Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior, 24385-24418 [2016-09433]

Download as PDF Vol. 81 Monday, No. 79 April 25, 2016 Part VI Department of Health and Human Services asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Food and Drug Administration 21 CFR Parts 882 and 895 Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior; Proposed Rule VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\25APP4.SGM 25APP4 24386 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules Written/Paper Submissions DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 882 and 895 [Docket No. FDA–2016–N–1111] Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule. The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or selfinjurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling. FDA is proposing to include in this ban both new devices and devices already in distribution and use. SUMMARY: Submit either electronic or written comments on the proposed rule by May 25, 2016. DATES: ADDRESSES: You may submit comments as follows: asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2016–N–1111 for ‘‘Proposal to Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. 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For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. Docket: For access to the docket to read background documents or the PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993–0002, 301–796–6527. SUPPLEMENTARY INFORMATION: Executive Summary Purpose of the Proposed Rule FDA is proposing to ban electrical stimulation devices (ESDs) used for selfinjurious or aggressive behavior. ESDs are devices that apply a noxious electrical stimulus to a person’s skin upon the occurrence of a target behavior in an attempt to condition the individual over time to reduce or cease the behavior. Self-injurious behaviors (SIB) and aggressive behaviors (AB) frequently manifest in the same individual, and people with intellectual or developmental disabilities exhibit these behaviors at disproportionately high rates. Notably, many such people have difficulty communicating and cannot make their own treatment decisions because of such disabilities, meaning many people who exhibit SIB or AB are among a vulnerable population. SIB commonly include: Head-banging, hand-biting, excessive scratching, and picking of the skin. However, SIB can be more extreme and result in bleeding, protruding, and broken bones; blindness from eyegouging or poking; other permanent tissue damage; or injuries from swallowing dangerous objects or substances. AB involve repeated physical assaults and can be a danger to the individual, others, or property. In our proposed rule, like much of the scientific literature, we discuss SIB and AB in tandem. ESDs are intended to reduce SIB and AB according to the principle of aversive conditioning. Aversive conditioning pairs a noxious stimulus with a target behavior such that the individual begins to associate the noxious stimulus with the behavior, with the intended result being that the individual ceases engaging in the behavior and, over time, becomes conditioned not to manifest the target behavior. A noxious stimulus is one that is uncomfortable or painful; the noxious stimulus delivered by an ESD is an E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules electric shock to the skin. Some ESDs are intended for other purposes, such as smoking cessation; however, the proposed ban includes only those devices intended to reduce or eliminate SIB or AB. ESDs are not used in electroconvulsive therapy, sometimes called electroshock therapy or ECT, which is unrelated to this proposed rulemaking. The effects of the shock are both psychological (including suffering) and physical (including pain), each having a complex relationship with the electrical parameters of the shock. As a result, the subjective experience of the person receiving the shock can be difficult to predict. Physical reactions roughly correlate with the peak current of the shock delivered by the ESD. However, various other factors such as sweat, electrode placement, recent history of shocks, and body chemistry can physically affect the sensation. As a result, the intensity or pain of a particular set of shock parameters can vary greatly from patient to patient and from shock to shock. Possible adverse psychological reactions are even more loosely correlated with shock intensity in that the shock need not exceed certain physical thresholds. Rather, the shock need only be subjectively stressful enough to cause trauma or suffering. Trauma becomes more likely, for example, when the recipient does not have control over the shock or has developed a fear of future shocks, neither of which is an electrical parameter of the shock. Whenever FDA finds, on the basis of all available data and information, that a device presents substantial deception or an unreasonable and substantial risk of illness or injury, and that such deception or risk cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, FDA may initiate a proceeding to ban the device. In making such a finding, FDA weighs the benefits against the risks posed by the device and considers the risks relative to the state of the art. With respect to ESDs for SIB and AB, FDA has weighed these factors based on consideration of information from a variety of sources, including the scientific literature, opinions from experts (including an advisory panel meeting), information from and actions of State agencies, information from the affected manufacturer, information from patients and their family members, and information from other stakeholders. FDA has determined that ESDs for SIB or AB present a number of psychological and physical risks: Depression, fear, escape and avoidance behaviors, panic, aggression, VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 substitution of other behaviors (e.g., freezing and catatonic sit-down), worsening of underlying symptoms (e.g., increased frequency or bursts of self-injury), pain, burns, tissue damage, and errant shocks from device misapplication or failure. Based on literature for implantable cardioverter defibrillators, FDA has determined that ESDs present the risks of posttraumatic stress or acute stress disorders, shock stress reaction, and learned helplessness. That literature provides additional support for the risks of depression, anxiety, fear, and pain. Experts in the field of behavioral science, State agencies that regulate the use of ESDs, the sole current manufacturer and user of ESDs, and individuals who were subject to ESDs corroborate most of these findings, and they attest to additional risks. Our search of the scientific literature revealed a number of studies showing that ESDs result in the immediate interruption of the target behavior upon shock, and some of the literature also suggested varying degrees of durable conditioning. However, the studies in the literature suffer from serious limitations, including weak study design, small size, and adherence to outdated standards for study conduct and reporting. The conclusions of several of the studies are undermined by study-specific methodological limitations, lack of peer review, and author conflicts of interest. There is also evidence that the shocks are completely ineffectual for certain individuals. FDA weighed the benefits against the risks. FDA recognizes that ESDs can cause the immediate interruption of self-injurious or aggressive behavior, but the evidence is otherwise inconclusive and does not establish that ESDs improve the underlying disability or successfully condition individuals to achieve durable long-term reduction of SIB or AB. The short-term effect of behavior interruption is outweighed by the numerous short- and long-term risks. For many individuals who exhibit SIB or AB, these risks are magnified by their inability to adequately communicate the harms they experience to their health care providers. Even if immediate cessation is achieved, without durable conditioning the target behavior will recur over time and necessitate ongoing shocks to cause immediate cessation, magnifying the risks. For some patients, the shocks are wholly ineffective and can lead to progressively stronger shocks with the same result. Thus the degree to which the risks outweigh the benefits increases over time. PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 24387 When considering the reasonableness of the risk of illness or injury posed by a device in a banning proceeding, FDA also considers the state of the art. Notably, the use of aversive conditioning in general, and ESDs in particular, has been on the decline for decades; only one facility in the United States still uses ESDs for SIB and AB. This decline is due in part to scientific advances that have yielded new insights into the organic causes and external (environmental or social) triggers of SIB and AB, allowing the field to move beyond intrusive punishment techniques such as aversive conditioning with ESDs. Moreover, punishment techniques (which include the use of ESDs) are highly contextsensitive, so the same technique may lose effectiveness simply by changing rooms or providers. The evolution of the state of the art responded to this limitation by emphasizing skills acquisition and individual choice. The evolution is also due in part to the ethical concerns tied to the risks posed by devices such as ESDs, especially regarding the application of pain to a vulnerable patient population. In light of scientific advances, out of concern for ethical treatment, and in an attempt to create generalizable interventions that work in community settings, behavioral scientists have developed safer, successful treatments. The development of the functional behavioral assessment, a formalized tool to analyze and determine triggering conditions, has allowed providers to formulate and implement plans based on positive techniques. As a result, multi-element positive interventions (e.g., paradigms such as positive behavior support or dialectical behavioral therapy) have become stateof-the-art treatments for SIB and AB. Such interventions achieve success through environmental modification and an emphasis on teaching appropriate skills. Behavioral intervention providers may also recommend pharmacotherapy (the use of medications) as an adjunct or supplemental method of treatment. Positive-only approaches are generally successful even for challenging SIB and AB, in both clinical and community settings. The scientific community has long since recognized that addressing the underlying causes of SIB or AB, rather than suppressing it with painful shocks, not only avoids the risks posed by ESDs, but can achieve durable, longterm benefits. Based on all available data and information, FDA has determined that the risk of illness or injury posed by ESDs for SIB and AB is substantial and E:\FR\FM\25APP4.SGM 25APP4 24388 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules unreasonable and that labeling or a change in labeling cannot correct or eliminate the unreasonable and substantial risk of illness or injury. The purpose of this proposed rule is to seek comments on these determinations as well as seek comments on FDA’s proposal to ban ESDs used for SIB or AB and comments on any other associated issues. Legal Authority The FD&C Act authorizes FDA to ban a device intended for human use by regulation if it finds, on the basis of all available data and information, that such a device presents substantial deception or an unreasonable and substantial risk of illness or injury. A banned device is adulterated except to the extent it is being studied pursuant to an investigational device exemption. This proposed rule is also issued under the authority to issue regulations for the efficient enforcement of the FD&C Act. In determining whether a deception or risk of illness or injury is ‘‘substantial,’’ FDA will consider whether the risk posed by the continued marketing of the device, or continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued marketing. Although FDA’s device banning regulations do not define ‘‘unreasonable risk,’’ FDA previously explained that, with respect to ‘‘unreasonable risk,’’ we will conduct a careful analysis of risks associated with the use of the device relative to the state of the art and the potential hazard to patients and users. The state of the art with respect to this proposed rule is the state of current technical and scientific knowledge and medical practice with regard to the treatment of patients exhibiting self-injurious and aggressive behavior. Thus, in determining whether a device presents an ‘‘unreasonable and substantial risk of illness or injury,’’ FDA analyzes the risks and the benefits the device poses to individuals, comparing those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice. Actual proof of illness or injury is not required; FDA need only find that a device presents the requisite degree of risk on the basis of all available data and information. Whenever FDA finds, on the basis of all available data and information, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury, and that such deception or risk cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, FDA may initiate a proceeding to ban the device. Summary of the Major Provisions of the Proposed Rule If this proposed rule is finalized as proposed, the ban would include devices that apply a noxious electrical stimulus to a person’s skin to reduce or cease aggressive or self-injurious behavior. The proposed ban would apply to devices already in commercial distribution and devices already sold to the ultimate user, as well as devices sold or commercially distributed in the future. A banned device is an adulterated device, subject to enforcement action. The ban may not, however, prevent further study of such devices pursuant to an investigational device exemption. Costs and Benefits of the Proposed Rule FDA is proposing to ban ESDs for the purpose of treating self-injurious or aggressive behavior. Because we lack sufficient information to quantify the benefits, we include a qualitative description of some potential benefits of the proposed rule. We expect that the rule would directly affect only one entity. In addition to the incremental costs this entity would incur to comply with the requirements of the proposed rule, there would be potential transfer payments of between $11.5 million and $15 million annually either within the affected entity or between entities. The present value of total costs over 10 years ranges from $0 million to $60.1 million at a 3 percent discount rate, and ranges from $0 million to $51.4 million at a 7 percent discount rate. Annualized costs range from $0 million to $6.8 million at a 3 percent discount rate and range from $0 million to $6.8 million at a 7 percent discount rate. TABLE OF ABBREVIATIONS AND ACRONYMS asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Abbreviation or acronym What it means AB ................................................... ABA ................................................. AE ................................................... DBT ................................................. DDS ................................................. DEEC .............................................. EA ................................................... ESD ................................................. FD&C Act ........................................ FONSI ............................................. GED ................................................ ICD .................................................. JRC ................................................. NASDDDS ....................................... NYSED ............................................ PBS ................................................. PTSD ............................................... SIB .................................................. SIBIS ............................................... Aggressive Behavior. Applied Behavior Analysis. Adverse Event. Dialectical Behavioral Therapy. (Massachusetts) Department of Developmental Services. (Massachusetts) Department of Early Education and Care. Environmental Assessment. Electrical Stimulation Device. Federal Food, Drug, and Cosmetic Act. Finding of No Significant Impact. Graduated Electronic Decelerator. Implantable Cardioverter Defibrillator. Judge Rotenberg Educational Center, Inc. National Association of State Directors of Developmental Disability Services. New York State Education Department. Positive Behavioral Support. Post-traumatic Stress Disorder. Self-Injurious Behavior. Self-Injurious Behavior Inhibiting System. Table of Contents I. Background A. Introduction B. What are SIB and AB, and how do they affect patients? VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 C. What are ESDs and how do they affect SIB and AB? D. How has FDA regulated ESDs in the past? E. Scope of the Ban F. Legal Authority PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 II. Evaluation of Data and Information Regarding ESDs A. Risks of Illness or Injury Posed by ESDs B. Effect on Targeted Behavior C. State of the Art E:\FR\FM\25APP4.SGM 25APP4 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules III. Determination That ESDs for SIB and AB Present an Unreasonable and Substantial Risk of Illness or Injury IV. Labeling V. Application of Ban to Devices in Distribution and Use VI. Proposed Effective Date VII. Analysis of Environmental Impact VIII. Economic Analysis of Impacts A. Introduction B. Summary of Costs and Benefits IX. Paperwork Reduction Act X. Federalism XI. References asabaliauskas on DSK3SPTVN1PROD with PROPOSALS I. Background A. Introduction Electrical stimulation devices (ESDs) for self-injurious behavior (SIB) or aggressive behavior (AB) are devices that apply a noxious electrical stimulus (a shock) to a person’s skin to reduce or cease such behaviors. Although FDA cleared a few of these devices more than 20 years ago, due to scientific advances and ethical concerns tied to the risks of ESDs, state-of-the-art medical practice has evolved away from their use and toward various positive behavioral treatments, sometimes combined with pharmacological treatments. Only one facility in the United States has manufactured these devices or used them on individuals in recent years. As a result of this evolution in treatment over the past several decades, the available data and information on the risks and benefits of ESDs are limited. Although the available data and information show that some individuals subject to ESDs exhibit an immediate reduction or cessation of the targeted behavior, the available evidence has not established a durable long-term conditioning effect or an overallfavorable benefit-risk profile for ESDs for SIB and AB. No randomized, controlled clinical trials have been conducted, and the studies that have been conducted are generally small and suffer from various limitations, including the use of concomitant treatments over long periods that make it difficult to determine the cause of any behavioral changes. The medical literature shows that ESDs present risks of a number of psychological harms including depression, posttraumatic stress disorder (PTSD), anxiety, fear, panic, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness (becoming unable or unwilling to respond in any way to the ESD); and the devices present the physical risks of pain, skin burns, and tissue damage. Because the medical literature likely underreports adverse events (AEs), risks identified through other sources, such as from experts in the field, State VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 agencies that regulate ESD use, and records from the only firm that has recently manufactured and is currently using ESDs for SIB and AB demand closer consideration. As discussed in section II.A, these sources further support the risks reported in the literature and indicate that ESDs have been associated with additional risks such as suicidality, chronic stress, acute stress disorder, neuropathy, withdrawal, nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and injuries from falling. In contrast to the state of the art for the treatment of SIB and AB, the risks of ESDs are unreasonable. As discussed later in this document, FDA has determined that ESDs present a substantial and unreasonable risk of illness or injury and that the risks cannot be corrected or eliminated by labeling. Thus, FDA has decided to ban these devices under section 516 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360f). The proposed rule applies to devices already in distribution and use, as well as to future sales of these devices. B. What are SIB and AB, and how do they affect patients? SIB and AB are among the most striking and devastating conditions associated with intellectual and developmental disabilities (Ref. 1). Individuals with such disabilities may exhibit destructive behavior that falls within two major categories, self-injury and aggression toward others or property. The most common forms of self-injury include head-banging, handbiting, excessive scratching, and picking of the skin. The most extreme cases of persons with serious self-injurious behavior afflict an estimated 25,000 or more individuals in the United States (Ref. 2). These more extreme behaviors usually involve repeated, self-inflicted, non-accidental injuries producing, for example: (1) Bleeding, protruding, and broken bones; (2) eye gouging or poking leading to blindness; (3) other permanent tissue damage; and (4) swallowing dangerous substances or objects. (For a more detailed technical discussion, see Ref. 3.) Persons who exhibit SIB also frequently demonstrate aggression, the other major category of destructive behavior. Aggressive behaviors encompass a wide range of behaviors, which are generally defined by conduct that, due to its intensity or frequency, presents an imminent danger to the person who demonstrates it, to other people, or to property (see, e.g., Ref. 4 PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 24389 for a discussion of aggression in autistic children). Aggressive behaviors that involve repeated physical assaults are dangerous particularly for caregivers and family. Beyond the potential for obvious physical injury, SIB and AB can be very distressing for parents and caregivers (Ref. 5), severely limit the patient’s participation in community activities, and lead to placement of the patient in a more restrictive living environment (Ref. 6). Accordingly, intervention is necessary for the safety of the individual engaging in the aggressive behavior, for those against whom the aggression is directed, and for the protection of property. The majority of published studies on SIB include aggression either as part of the description of the clinical spectrum of the behavior or as an inclusion criterion for the clinical study. Accordingly, this proposed rule addresses self-injury and aggression in tandem as SIB and AB. Destructive behavior in both major categories— aggression and self-injury—are often present in individuals with intellectual or developmental disabilities. Examples of those disabilities include, but are not limited to: Autism spectrum disorder, Cornelia de Lange syndrome, Down syndrome, Fragile X syndrome, hereditary sensory neuropathy, LeschNyhan syndrome, Rett syndrome, and Tourette syndrome. Those disabilities may also include visual impairment, severe intellectual impairment, and a variety of cognitive and psychiatric disorders. Estimates of the prevalence of SIB in individuals with intellectual or developmental disabilities range from 2.6 percent to 40 percent (Ref. 7), or 2 to 23 percent in community samples (Ref. 8). More recently, one analysis found a prevalence of SIB in a clinical population of children with developmental disabilities at 32 percent, suggesting that the actual prevalence may be at the high end of earlier estimates (Ref. 9). Estimates of the prevalence of AB in individuals with intellectual or developmental disabilities range as high as 52 percent, though 10 percent is more commonly reported (Ref. 8). Thus, by conservative estimates, counting only individuals who have intellectual or developmental disabilities (and not all people who manifest SIB or AB), at least 330,000 people in the United States manifest SIB, AB, or both; less conservative estimates are much higher (see Refs. 3 and 8).1 1 An estimated 1 to 3 percent of individuals in the United States have an intellectual or developmental E:\FR\FM\25APP4.SGM Continued 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 24390 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules C. What are ESDs and how do they affect SIB and AB? As stated, ESDs apply a noxious electrical stimulus (a shock) to a person’s skin upon the occurrence of a target behavior in an attempt to reduce or cease the behavior. As such, ESDs are a type of aversive conditioning device (‘‘aversive’’). ESDs apply shocks to the skin. ESDs are not used in ECT, sometimes called electroshock therapy, which is unrelated to this rulemaking. The electrical shock from an ESD is intended to interrupt the undesirable behavior and result in its quick cessation. Repeatedly pairing the shock with the unwanted behavior is intended to cause individuals to associate the two and thereby induce them to decrease the frequency of the behavior or stop it altogether. In order to achieve the intended results, the shock must be applied during the behavior (for cessation and decrease) or immediately afterward (for decrease). ESDs are intended to affect behavior in two ways: By interrupting the target behavior as an immediate response to the stimulus and, over time, through a conditioned reduction in the target behavior. The main components of ESDs are an electrical stimulus generation module, electrodes, and a trigger switch. Either a remote monitor module or an automatic mechanism can trigger the electric shock to the individual. Typically, the patient carries the stimulus generation module, which applies an electrical current (the shock) to the individual’s skin via electrodes. When a remote monitor is used, an observer determines when to apply an electrical shock to the patient and triggers a shock from a specific stimulus generation module via a radiofrequency signal. Alternatively, a sensor can detect certain unwanted behaviors and automatically activate the generation module. For example, an accelerometer attached to the head could detect headbanging and, when the behavior is severe enough, trigger an electrical shock. Although several factors specific to the patient affect shock perception, the key device output characteristics that most affect shock perception include: Electric current, voltage, skin resistance (or load), pulse width, shock duration, output frequency and waveform, disability (Ref. 8). Given a U.S. population of 330 million, at least 3.3 million people would have such a disability; 10 percent of 3.3 million is 330,000, and 2 percent of 3.3 million is 66,000. If there is no overlap, the total would be 396,000 people. These numbers are based on the lowest bounds reported in Ref. 8. Using the same source and method, the highest bound would yield an estimate of about 7.4 million people. VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 electrode characteristics (e.g., size, location, design, or material), and the number and frequency of shocks delivered. For the purposes of this proposed rule, a stronger shock is one for which at least one of those parameters is adjusted to increase the intensity or sensation. Electric current, measured in milliamperes (mA) for ESDs, is the primary variable for determining the effects of an electric shock that passes through the body. To determine the current output of a device designed to deliver a constant voltage, the voltage is divided by the electric resistance, measured in ohms (W), the relationship described by Ohm’s Law. A lower resistance for a given voltage results in higher current; the skin’s conducting resistance can vary between 1 kW and 100 kW (Refs. 10 and 11). Sweat and blood are excellent conductors and therefore lower the conducting resistance, which increases the current and the intensity of the stimulus. The sensory nerves respond to the current as a function of its strength and duration. A stronger current will elicit a response with a shorter pulse width, and a weaker current will need a longer pulse width to elicit the same response. The pulse width (or pulse duration) is the length of time a pulse of current is applied to the skin, measured in milliseconds for ESDs. Longer pulse durations have been shown to increase the intensity or unpleasantness of the sensation in healthy subjects (Refs. 12– 14). The characteristics of the electrodes that deliver the shock to the skin also affect the perception of the shock. The amount of current delivered per unit area of an electrode is referred to as the current density. A higher current density has been found to correspond with a more intense or unpleasant feeling (Refs. 15 and 16). One study has shown that smaller electrodes deliver painful shocks that are described as sharp, cutting, or lacerating. Larger electrodes for the same current are associated with pain that was pinching, pressing, or gnawing (Ref. 16). A related measure, power density, is found by multiplying the current and the voltage and relating the product to surface area; it is expressed as watts per unit area. Both current and power densities correlate with the risk of burns; a higher current or power density increases the risk. The risk of burns also increases when the current itself is direct current; all FDA-cleared ESDs utilize alternating current (AC) rather than direct current (DC). Electrodes additionally affect pain sensation in that placement on locations PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 with a higher density of sensory nerves will result in more pain. For that reason, the hands, feet, genitals, underarms, torso, neck, and face will be particularly sensitive to shocks. Repeated shocks to the same location will also alter the perception, increasing intensity or pain (Refs. 17–19). The exact mechanism behind this change is unclear, but one hypothesis holds that the changing sensation may result from changes in the skin’s electrical resistance (Ref. 19). Others have hypothesized that repeated stimulation depletes endorphins, which are chemicals that affect pain sensation (Ref. 17). Finally, with regard to key device output parameters, some authors have attempted to relate physiological responses, sensations and muscle contraction for example, to electric current (e.g., Refs. 10, 11, and 20). The Judge Rotenberg Educational Center, Inc. (JRC), the only entity of which FDA is aware that has recently manufactured ESDs and that currently uses ESDs, has submitted a similar comparison (Ref. 21). However, comparisons based solely upon the electric current oversimplify the relationship because they do not account for other key parameters, nor do they account for intersubject variability in perception. (See, for example, Refs. 11, 17, 18, and 22–25). Such comparisons also do not account for the recipient’s psychological state (Refs. 18, 22, and 23), which can affect the response to shocks. Furthermore, the relationships between current and response as reported by these authors (Refs. 10, 11, and 20) are more relevant in a setting where a body part comes into direct contact with a 60-Hz AC electrical source (e.g., a current from a wall outlet), with the current passing through the chest. In contrast, ESDs provide localized stimulation to the skin through an electrode interface. Thus, although the amount of current may suggest a type of response (e.g., tingling, pain, or involuntary muscle contraction), predictions based on such thresholds are subject to considerable uncertainty. These key device output parameters affect the experience of the shock primarily in terms of physiological responses (see Ref. 3 for a more technical discussion). As explained in more detail in section II.A.1, a stimulus need not be physically intense to trigger an adverse psychological reaction. Thus, although lower peak current or shorter pulse duration corresponds with lower physical intensity, neither necessarily corresponds with a less-adverse psychological response. Table 1 summarizes the device output characteristics of ESDs for SIB or AB E:\FR\FM\25APP4.SGM 25APP4 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules that have been cleared by FDA or are currently in use. Note that FDA has 24391 cleared 510(k)s for ESDs for SIB or AB from other manufacturers besides JRC. TABLE 1—DEVICE OUTPUT CHARACTERISTICS Device name Average current Max current Max voltage Pulse width Shock duration Frequency Power density Whistle Stop 1 ... SIBIS ................. 10 mA at 20 kW 10 mA .............. 200 V ............... 200 V ............... 1–2 ms ............ 6.2 ms ............. 0.5–12 s .......... 0.1–0.2 s ......... 10 Hz ............... 80 Hz ............... 0.02 W/cm. 2 0.16 W/cm. 2 GED, GED–3A 2 ......................... 3.5 mA at 20 kW. 12 mA at 5 kW 150 V ............... 3.125 ms ......... 2 s ................... 80 Hz ............... 1.01 W/cm. 2 GED–4 2 ............ 42 mA at 5 kW 29.4 mA at 5 kW. 90 mA .............. ......................... 3.125 ms ......... 2 s ................... 80 Hz ............... 1 The 510(k) did not include enough information for FDA to determine the average current of the device (as indicated by blank field). 2 The GED–3A and GED–4 have not been cleared or approved by FDA, and we do not have information about all device characteristics (as indicated by blank fields). asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Again, individual patient variability makes comparison across devices—and even individual shock applications— difficult. Some people are generally highly sensitive to current, experiencing involuntary muscle contraction from static electric shocks. On the other end of the spectrum, some individuals can draw a large static electric spark and hardly perceive it, much less experience a muscle spasm. Studies of subjects without intellectual or developmental disabilities have demonstrated a large range of intersubject variability for equally applied shocks. For example, one study found that the range of pain thresholds was 3.9 to 11.6 mA (Ref. 11), while another found the range was 0.45 to 2.4 mA (Ref. 25). Such articles often did not include key output characteristics, such as pulse width and frequency or electrode size and placement, further confounding attempts to compare or apply the findings. In light of variability and methodological limitations underlying the reported current-response relationships, physiological responses, including pain perception, are difficult to predict accurately, especially based solely on the current. D. How has FDA regulated ESDs in the past? In 1979, FDA classified aversive conditioning devices as class II (see § 882.5235 (21 CFR 882.5235)), which was consistent with the recommendation of the Neurological Device Classification Panel of the Medical Device Advisory Committee in 1978. Such devices may or may not use electric shocks to administer a ‘‘noxious stimulus to a patient to modify undesirable behavioral characteristics’’ (§ 882.5235). Thus, ESDs intended to treat SIB and AB are within the aversive conditioning device classification regulation. The proposed rule for classifying aversives, including ESDs, focused on the risks of: (1) Worsened psychological conditions, (2) errant VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 electric shocks, and (3) the harmful or lethal nature of excess electric current or its inappropriate application (43 FR 55705, November 28, 1978). At the time, FDA and the panelists believed that performance standards could adequately assure the safety and effectiveness of aversives. We received no comments from the public on the proposed rule, and we issued the final rule classifying aversives as proposed at § 882.5235 (44 FR 51726 at 51765, September 4, 1979). FDA has cleared four devices for the treatment of SIB as substantially equivalent to the ones initially placed into class II, 510(k) notification numbers and clearance dates in parentheses: • Stimulator Sonic Control, ‘‘Whistle Stop’’ (K760166; July 20, 1976); • Self-Injurious Behavior Inhibiting System, ‘‘SIBIS’’ (K853178; February 28, 1986); • SIBIS Remote Actuator (K871158; May 29, 1987); and • Graduated Electronic Decelerator, ‘‘GED’’ (K911820; December 5, 1994). A prescription is required for each, meaning that Federal law restricts the sale of these aversives to professionals licensed according to State requirements or those acting pursuant to a licensed professionals orders (see 21 CFR 801.109). As part of the evaluation of the premarket notifications, i.e., the 510(k) submissions, FDA reviewed the average current (the amount of electricity) and power density of the shocks (the wattage applied to a given area of skin), among other things. Average current and power density are important parameters in determining the likelihood and severity of a potential physical injury from a shock. The cleared ESDs include warnings never to place electrodes on the head or chest, or in such a way that current would flow through the chest because this could cause ventricular fibrillation (a dangerous irregularity in the heartbeat). We are aware of only one manufacturer, JRC, that has recently PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 manufactured ESDs and that currently uses ESDs, including devices that we have not previously cleared. JRC uses these devices because it is also a residential facility, and its employees apply the devices to individuals there. In 2000, FDA incorrectly notified JRC that it qualified for exemption from registration and 510(k) requirements under 21 CFR 807.65(d). Once FDA recognized its error, FDA sent JRC an Untitled Letter on May 23, 2011, and a Warning Letter on December 6, 2012, for violations related to the lack of FDA clearance or approval for the modified GED devices.2 FDA now has a better understanding of the risks and benefits presented by these devices than it did 36 years ago when these devices were classified, and, as discussed later in sections II.A and II.B, the state of the art for the treatment of SIB and AB has progressed significantly over that time period. As a result, FDA now believes that the risk of illness or injury from the use of ESDs for the treatment of SIB and AB is unreasonable and substantial. E. Scope of the Ban The ban would apply to devices that apply a noxious electrical stimulus to a person’s skin to reduce or stop aggressive or self-injurious behavior. (See section I.B for a discussion of the relevant behaviors; see also Ref. 3 for a more technical discussion of the scientific literature regarding these behaviors.) To FDA’s knowledge, the only such devices that are currently in use are two models of the GED device (the GED–3A and GED–4), neither of which has been cleared or approved by the Agency. The ban would not apply to ESDs used to create aversions to other conditions or habits, such as smoking. Although other ESDs have parallels in 2 The Warning Letter is available on the Internet at http://www.fda.gov/ICECI/EnforcementActions/ WarningLetters/2012/ucm331291.htm. E:\FR\FM\25APP4.SGM 25APP4 24392 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS treatment strategy and method, those devices address very different conditions in very different patient populations. Smoking-cessation devices differ with respect to whether patients have control over the shocks—and what level of control they have—as well as how the electric shock affects the target behavior and underlying conditions. These differing types of ESDs thus present different benefit-risk profiles. Importantly, individuals who manifest SIB or AB typically have additional vulnerabilities that relate directly to the risks of the treatment method. For example, individuals with intellectual or developmental disabilities who manifest SIB or AB, and who have difficulty communicating pain or other harms that may be caused by ESDs would bear a higher risk of injury from the shock than smokers who choose to use an ESD to help quit smoking. Those smokers, if without intellectual or developmental disabilities, can immediately communicate pain to the device’s controller or remove the device themselves. They can communicate symptoms of other harms that may be caused by ESDs, such as PTSD, to their health care provider, which may lead to discontinuation of the device’s use. Communication challenges in patients who suffer from SIB and AB are discussed in the literature, were raised by the advisory panel, and are reviewed in more detail in section II.A. F. Legal Authority Section 516 of the FD&C Act authorizes FDA to ban a device intended for human use by regulation if it finds, on the basis of all available data and information, that such a device ‘‘presents substantial deception or an unreasonable and substantial risk of illness or injury’’ (21 U.S.C. 360f(a)(1)). A banned device is adulterated under section 501(g) of the FD&C Act (21 U.S.C. 351(g)), except to the extent it is being studied pursuant to an investigational device exemption under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)). This proposed rule is also issued under the authority of section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which provides authority to issue regulations for the efficient enforcement of the FD&C Act. In determining whether a deception or risk of illness or injury is ‘‘substantial,’’ FDA will consider whether the risk posed by the continued marketing of the device, or continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 marketing (see § 895.21(a)(1) (21 CFR 895.21(a)(1))). Although FDA’s device banning regulations do not define ‘‘unreasonable risk,’’ in the preamble to the final rule promulgating 21 CFR part 895, FDA explained that, with respect to ‘‘unreasonable risk,’’ it ‘‘will conduct a careful analysis of risks associated with the use of the device relative to the state of the art and the potential hazard to patients and users’’ (44 FR 29214 at 29215, May 18, 1979; Ref. 25a). The state of the art with respect to this proposed rule is the state of current technical and scientific knowledge and medical practice with regard to the treatment of patients exhibiting selfinjurious and aggressive behavior. Thus, in determining whether a device presents an ‘‘unreasonable and substantial risk of illness or injury,’’ FDA analyzes the risks and the benefits the device poses to individuals, comparing those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice. Actual proof of illness or injury is not required; FDA need only find that a device presents the requisite degree of risk on the basis of all available data and information (H. Rep. 94–853 at 19; 44 FR 28214 at 29215). Whenever FDA finds, on the basis of all available data and information, that the device presents substantial deception or an unreasonable and substantial risk of illness or injury, and that such deception or risk cannot be, or has not been, corrected or eliminated by labeling or by a change in labeling, FDA may initiate a proceeding to ban the device (see § 895.20). If FDA determines that the risk can be corrected through labeling, FDA will notify the responsible person of the required labeling or change in labeling necessary to eliminate or correct such risk (see § 895.25). Section 895.21(d) requires this proposed rule to briefly summarize: • The Agency’s findings regarding substantial deception or an unreasonable and substantial risk of illness or injury; • the reasons why FDA initiated the proceeding; • the evaluation of the data and information FDA obtained under provisions (other than section 516) of the FD&C Act, as well as information submitted by the device manufacturer, distributer, or importer, or any other interested party; • the consultation with the classification panel; • the determination that labeling, or a change in labeling, cannot correct or eliminate the deception or risk; PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 • the determination of whether, and the reasons why, the ban should apply to devices already in commercial distribution, sold to ultimate users, or both; and • any other data and information that FDA believes are pertinent to the proceeding. We have grouped some of these together within broader categories and addressed them in the following order: • Evaluation of data and information regarding ESDs, including data and information FDA obtained under provisions other than section 516 of the FD&C Act, information submitted by the device manufacturer and other interested parties, the consultation with the classification panel, and other data and information that FDA believes are pertinent to the proceeding, with respect to risks, benefits, and the state of the art; • the reasons FDA initiated the proceeding and FDA’s determination that ESDs for SIB and AB present an unreasonable and substantial risk of illness or injury (FDA has not made a finding regarding substantial deception); • FDA’s determination that labeling, or a change in labeling, cannot correct or eliminate the risk; and • FDA’s determination that the ban applies to devices already in commercial distribution and sold to ultimate users, and the reasons for this determination. II. Evaluation of Data and Information Regarding ESDs In considering whether to ban ESDs, FDA first conducted an extensive, systematic literature review to assess the benefits and risks associated with ESDs as well as the state of the art of treatment of patients exhibiting SIB and AB. In the literature review, as explained earlier, SIB and AB were considered in tandem, and these conditions presented in individuals with intellectual and developmental disabilities, such as autism spectrum disorder, Down syndrome, Tourette syndrome, as well as other cognitive or psychiatric disorders and severe intellectual impairment (including a broad range of intellectual measures). The studies encompassed both children and adults. (For more technical details, see Ref. 3.) FDA next convened a meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee (‘‘the Panel’’) on April 24, 2014 (‘‘the Panel Meeting’’), in an open public forum, to discuss issues related to FDA’s consideration of a ban on ESDs for SIB and AB (see 79 FR 17155, March 27, 2014; Ref. 26). Although FDA is not E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules required to hold a panel meeting before banning a device, FDA decided to do so in the interest of gathering as much data and information as possible, from experts in relevant medical fields as well as all interested stakeholders, before proposing this significant regulatory action. Eighteen panelists with expertise in both pediatric and adult patients represented the following biomedical specialties: Psychology, psychiatry, neurology, neurosurgery, bioethics, and statistics, as well as representatives for patients, industry, and consumers (Ref. 27). FDA provided a presentation that described the banning standard, the regulatory history of aversive conditioning devices, alternative treatments, and a summary of the benefits and risks of ESDs, including a comprehensive, systematic literature review based on the information available at that time (Refs. 3 and 28). After the Panel Meeting, we reviewed all 294 comments from 281 unique commenters submitted to the public docket created for the Panel Meeting (Docket No. FDA–2014–N– 0238). FDA considered all available data and information from a wide variety of sources, including from the categories listed in this document. In weighing each piece of evidence, FDA took into account its quality, such as the level of scientific rigor supporting it, the objectivity of its source, its recency, and any limitations that might weaken its value. Thus, for example, we generally gave much more weight to the results of a study reported in a peer-reviewed journal than we did to non-peerreviewed papers. • The scientific literature. FDA considered published scientific sources to understand SIB and AB as well as the risks and benefits of ESDs and the state of the art for the treatment of challenging behaviors. However, several limitations influenced the conclusions drawn from the literature, including the likely underreporting of AEs, reporting biases, and various methodological weaknesses. • Information and opinions from experts, including those expressed by the panelists at the Panel Meeting, as well as those expressed in individual expert reports obtained by FDA from Drs. Tristram Smith, Gary LaVigna, and Fredda Brown. Each of these experts has experience in the field of behavioral psychology, particularly with individuals who manifest SIB or AB. Drs. LaVigna and Brown have expertise regarding the state of the art for treatment of SIB and AB and the development of positive behavioral treatment plans for patients, including VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 for transition away from ESDs and other aversive strategies. FDA obtained reports from these experts to supplement our understanding of the risks and benefits of ESDs and the state of the art for the treatment of SIB and AB. • Information from State agencies and State actions on ESDs. FDA has considered information regarding the use of ESDs for SIB and AB from agencies in Massachusetts and New York. These agencies possess substantial information on ESDs for SIB and AB because the overwhelming majority of patients—nearly 75 percent—on whom ESDs are used are from these two States. According to information provided by JRC in its comments, 60 of the 82 individuals enrolled at JRC as of April 2014 on whom GED devices were used are from these two States. FDA also considered a comment from the Executive Director of the National Association of State Directors of Developmental Disabilities Services (NASDDDS), which was supportive of a ban, and various State legal actions related to the use of ESDs for SIB and AB. • Information from the affected manufacturer/residential facility. In addition to presenting information at the Panel Meeting and responding to questions from Panel members, JRC has made several submissions to the Panel Meeting docket, as has a former JRC clinician. • Information from patients and their family members. Three individuals formerly on ESDs at JRC and family members of four such individuals currently at JRC spoke against a ban at the Panel Meeting. Two associations of family members of such individuals submitted comments opposing a ban (one of the comments included 32 letters from family members). Two individuals formerly on ESDs at JRC spoke in favor of a ban at the Panel Meeting, and one other individual submitted a comment in favor of a ban. In 2013 and 2014, FDA clinicians interviewed three individuals formerly on ESDs at JRC by phone (one of whom spoke in favor of a ban at the Panel Meeting). • Information from other stakeholders, including other government entities, disability rights groups, and members of the public. In addition to NASDDDS and a JRC parents group, referenced earlier, 15 other organizations concerned with the treatment and the rights of individuals with disabilities spoke at the Panel Meeting, all of which supported a ban. Twenty-two disability rights organizations submitted written PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 24393 comments to the Panel Meeting docket, one of which was signed by 23 disability rights groups. Nine of these organizations were among the 15 represented at the Panel Meeting. All of these comments support the ban. FDA also received a comment from the U.S. Department of Justice Civil Rights Division supportive of a ban, and we considered information from the National Council on Disability, the National Institutes of Health, and the United Nations Special Rapporteur on Torture. A. Risks of Illness or Injury Posed by ESDs 1. Scientific Literature FDA conducted an extensive, systematic review of the medical literature for harms, i.e., AEs, associated with ESDs to understand specific risks and dangers that ESDs present to individuals’ health. As previously discussed, the focus of the analysis in considering a ban is on risks and does not require proof of actual harm, but evidence of actual harms helps inform the analysis. One prospective casecontrol study and one retrospective chart review of 60 patients reported AEs (Refs. 29 and 30, respectively). Additionally, 26 case reports or series encompassing 66 subjects included an assessment of AE occurrences. Ten other case reports or series did not assess AEs, and 6 articles, encompassing 11 subjects in total, noted that the researchers did not observe AEs in their subject population. (See table 4 in Ref. 3 for a summary of articles reviewed for adverse events.) We identified the following AEs in the literature. a. Psychological risks. The risks of psychological harm are less tightly linked to the electrical parameters of an ESD shock than are physical risks (section I.C discussed shock parameters and how they relate to the physical response). For example, when the recipient does not have control over the shocks and has previously received multiple such shocks, psychological trauma such as an anxiety or panic reaction can result even when the strength is relatively modest (Ref. 31). In this example, the shock does not necessarily need to be stronger to increase the risk of psychological trauma; it need only recur. Similarly, the shock need not be painful; it need only be psychologically stressful. Further, a series of less traumatic events can cause the development of stress disorders such as PTSD. The underlying trauma need not be a single, discrete event, although a single trauma can lead to PTSD (Ref. 32; see also Ref. E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 24394 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules 31, discussing research on stressors prior to the 2013 update of the Diagnostics and Statistical Manual of Mental Disorders). Shocks that may be tolerable on their own could, in series, amount to a traumatic experience leading to a stress disorder. (See Ref. 33 discussing impaired cue-reversal independent of level of trauma.) In turn, such disorders can leave an individual susceptible to future traumas such as anxiety reactions that can be triggered by a relatively weak stimulus. For example, a provider reaching for an ESD remote control can trigger an anxiety response in individuals wearing ESDs, even without a shock. Thus, although a shock may need to surpass a minimum subjective threshold to be harmful (e.g., the shock needs to be sufficiently stressful to the recipient), that subjective minimum (what is sufficiently stressful) does not correspond with a particular objective minimum (shock parameters). Several articles reported aversion, fear, and anxiety in response to ESDs. One article states that ESDs may initially evoke fear, panic, and even aggression responses (Ref. 34). For the most part, researchers have interpreted these events as anticipatory responses prior to or upon stimulus application. In addition to reports of panic and bouts of aggression, others have reported events such as screaming, crying, or shivering upon device application; grimacing; flinching; perspiring; and escape behavior (Refs. 34–43). One article reported a temporary aversion to the experimenter (Ref. 36). Such fear, anxiety, or panic reactions are additionally concerning because when they cause the individual to sweat, they would lead to electrical conductivity changes across the skin that increase the intensity of the electric shock. Other articles report substitution of behaviors—negative or collateral—that span a range of severity. One author speculated that, in institutional settings, ‘‘the probability that a replacement behavior will be undesirable is quite high’’ (Ref. 44). Some patients ‘‘froze by refraining from showing any sort of behavior’’ (Ref. 34). Similarly, others reported a ‘‘pseudocatatonic sit-down,’’ i.e., muscular freezing or melting (Ref. 45). One study described temporary tensing of the body and noted attempts to remove the device or grab the transmitter during treatment (Ref. 30). Some patients resorted to hostility and retaliation (Ref. 46), including surrogate retaliation, threats, and warnings (Ref. 45). In some patients, another undesirable behavior known as selfrestraint, where patients attempt to physically restrain themselves, for example, with their clothing, emerged VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 or intensified (Refs. 29 and 47). Others exhibited lesser self-injury and aggression, non-injurious pinching, emotional behaviors, and napkintearing. (See also Refs. 30 and 43.) In some cases, crying increased (Ref. 48). One study reported that, as measured by rating scales of dependency, affectionseeking increased repeatedly during treatment (Ref. 42). Temporary or long-term increases in symptoms have also been attributed to ESDs in the literature. One article reported increases in emotionality and the frequency of self-injury, as well as post-treatment incontinence (Ref. 49). Another observed increasing episodic ‘‘bursts’’ of self-injury, eventually reaching the point that extended treatment with the ESD became impossible to maintain (Ref. 50). Some ESDs have been used for conditions other than SIB and AB, e.g., obsessions or compulsions, according to the same principle of aversive conditioning. FDA believes that reports of AEs from these alternative uses are informative regarding the risks of ESDs for SIB and AB because individuals with ESDs for other conditions generally do not have the same patient vulnerabilities that often accompany SIB and AB. As discussed in sections II.A.2 and A.3, these vulnerabilities generally increase the risk of harm from ESDs for individuals who manifest SIB or AB, so any harms from ESDs for other uses would be at least as likely, if not more so, to cause harm to many patients exhibiting SIB or AB. One article on the effects of shock on five subjects to reduce obsessions and compulsions reported that one subject demonstrated anxiety and psychotic delusions (Ref. 51). One case-control study on ESDs used to treat alcohol dependence in 12 subjects found that symptoms of experimental repression, such as headaches, restlessness, and mild dysphoria, were common and appeared usually within 3 or 4 days of the treatment (Ref. 52). Another researcher performed a prospective study of ESDs used for smoking cessation in 14 subjects. The author reported that seven subjects exhibited mild transient depression (Ref. 53). FDA acknowledges that confounding factors potentially contributed to these AEs. Since ESDs are aversive conditioning devices, FDA also considered AEs associated with aversive conditioning more generally. We identified 12 review articles examining AEs associated with punishment or aversive conditioning. Many of the reviews acknowledge the possibility of negative emotional reactions associated with punishment in general, such as fear or avoidance (Refs. PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 54–59) and anxiety and depression (Ref. 54). Some reviews, similar to the findings specific to ESDs, noted AEs that include retaliation, increased aggression, or substitution of one injurious behavior for another (Refs. 54 and 57–60). FDA believes that the risks posed by another type of device that delivers a shock to the patient are instructive. Specifically, a comparison to implantable cardioverter defibrillator (ICD) devices further supports the potential for certain psychological risks in patients receiving shocks from ESDs for SIB and AB. While the strength and purposes of the shock differ significantly between ICDs and ESDs, the psychological risks posed by ESDs do not necessarily depend on the strength of the shock, as discussed earlier, and FDA does not believe the different purposes of the shocks undermine the comparison for the following reasons. Treatment with either of these devices entails several similar characteristics that support a comparison, including the lack of patient control over the shocks, the application of multiple shocks, and the startling or unpleasant nature of the shocks. We found that fear of future shocks, in particular, is a trauma that is shared for both the ICD and ESD populations, unlike other trauma experiences in which subsequent trauma (repetition of the experience) is unlikely, indicating that ongoing application worsens the harm (Ref. 61). The following risks have been reported in the literature for ICDs: The development of PTSD, acute stress disorder, a shock stress reaction (a temporary condition), learned helplessness, depression, and anxiety (Refs. 61–63). A contributing factor in the development of these harms in patients with an ICD may be that treatment with an ICD may act as a constant reminder of the underlying life-threatening disease condition (Ref. 64). A 2011 report observed that ‘‘[t]he available research literature can only provide a limited view of whether ICD shock or the potentially life-threatening arrhythmic condition is the primary driver of a PTSD presentation’’ (Ref. 61). However, Sears and Conti report that ‘‘[s]hock is the major distinguishing factor between patients with ICDs and general cardiac patient populations’’ (Ref. 63), meaning that the presence of an ICD, rather than the underlying cardiac condition, increases the psychological risks. Other authors have reported that ICD shocks may cause distress either from the associated pain, skeletal muscle contraction, and nerve E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules stimulation or merely from fear of shocks (Ref. 62). Because of the similar characteristics of the shocks delivered by ICDs and ESDs, and because the identified risks may be attributable to the ICD shock itself, as opposed to the fear of a lifethreatening condition, the risks of development of PTSD or a shock stress reaction, learned helplessness, depression, or anxiety may also exist when shocks are applied by ESDs in patients with SIB or AB. FDA notes that due to the drastically different intended uses, patient populations, benefit-risk profiles, and state of the art for these devices, FDA is not considering banning ICDs. b. Physical risks. Research shows that shock strength and other device characteristics play a role in shaping the physical response to ESDs, such as whether the patient receives burns or experiences pain (see section I.C). We note that the lack of complete information regarding shock characteristics in much of the literature can make it difficult to determine to which ESDs these findings are applicable. The literature contains many reports of tissue damage or burns from ESDs. Reports of skin damage ranged from burns to bruises to slightly reddened or discolored areas. In all such reports, the effects were temporary (Refs. 29, 30, 39, 41, 50, and 65). Given that ESDs achieve their intended effects by causing an aversion with an electric shock, it is not surprising that researchers have reported experiencing or observing pain upon ESD application to themselves or their patients. For example, one experimenter stated that he definitely felt pain when he applied the ESD to himself. He described it like a dentist drilling on an un-anesthetized tooth, but the pain terminated when the shock ended (Ref. 36). Another report observed pain upon stimulation by the ESD (Ref. 35), and another observed a tremor in the thigh (Ref. 36). Although ESDs are intended to apply an aversive stimulus, and any pain that results from ESDs may cause an aversive reaction, pain is nonetheless a harm that should be considered in our analysis of risks posed by the device. Finally, two articles reported misapplication or device failure (Refs. 39 and 65). In such cases, there is a risk that any of the harms discussed in this section may occur but without any possibility of benefit. 2. Likely Underreporting of AEs The Agency’s analysis indicates that the medical literature suffers from some VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 significant limitations and has likely underreported AEs associated with ESDs for a number of reasons. Perhaps most importantly, the devices have been studied only on a very small number of subjects, many of whom would have difficulty communicating or otherwise demonstrating AEs and injuries. The bulk of the articles describe case reports or series, employing only retrospective reviews of clinical experience, not prospective studies. Further, most of the research articles were published in the 1960s and 1970s, before significant advances in the ability to diagnose and classify psychological AEs such as PTSD. The dated nature of most of the research also means it did not adhere to modern standards for AE monitoring. Simply put, researchers likely did not report AEs because they had not planned to study them separately. None of the articles on the application of ESDs described an attempt to assess AEs systematically, and many articles did not state whether the authors attempted to assess AEs at all. Finally, researcher bias also may have contributed to underreporting of AEs. As noted, the literature review suggests some subjects’ difficulty with reporting AEs due to the subjects’ disability likely hindered any assessment of AEs, particularly psychological AEs. Since SIB and AB often present in individuals with cognitive, intellectual, or psychiatric conditions, SIB and AB affect many individuals with diminished communication abilities. Patients who exhibit SIB or AB may not offer—or providers may not recognize—feedback indicating injuries from misfires or other erroneous applications of ESDs. For example, conditions such as an autism spectrum disorder may impair expressions of pain (see Ref. 66 for a discussion of pain sensitivity and expression in autistic individuals). In such a case, an AE could go unrecognized because the provider does not understand the individual’s response, if any. Worse, some individuals’ impaired ability to communicate, express themselves, or associate cause and effect, coupled with the difficulty providers may have in distinguishing underlying symptoms from negative effects of ESDs, compounds the dangers posed by these devices. This is because individuals’ impairments with communication or stimulus association may prevent the individuals and their health care providers from mitigating or avoiding both physical and especially psychological harms. (See section II.C.1 for a discussion of interventions that do not rely on stimulus association.) In PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 24395 such circumstances, ESDs are riskier than for other patients on whom ESDs are used. For the reports of AEs that do exist, many of those researchers published during the 1960s and 1970s, an era when conceptions of disease and how a person’s physiology may affect or cause disease, i.e., pathophysiology, differed significantly from current medical science, particularly psychiatric pathophysiology. As a result, those researchers may have interpreted pathological processes differently. For instance, they may not have recognized certain currently accepted disease processes like acute and posttraumatic stress. Some researchers did not report pain or discomfort as AEs since they were considered the ESDs’ intended result and indicators of effectiveness. (See, e.g., Refs. 44 and 57). In short, because science has advanced since much of the AE reporting, FDA believes existing AE reports in the literature are likely not comprehensive by current scientific and clinical reporting standards. The Agency’s analysis also suggests the possibility of bias against reporting AEs. As previously noted, the majority of articles did not define a systematic method for assessing AEs. In one review, the authors concluded that there was no evidence associating AEs with ESDs (Ref. 67). However, the authors went on to opine, ‘‘in light of the intrusive nature of shock treatment, it is puzzling that so few negative side effects have been reported. In interpreting the existing literature, we might be wise to consider the possibility that some investigators have been predisposed to see only the positive side effects.’’ Similarly, the reports of treatment relapse in the literature may not reflect the actual prevalence in clinical settings because such cases are less likely to be submitted or accepted for publication (Ref. 59). Potential bias against AE reporting might also have influenced the authors of the article that included the largest group of individuals (60) subject to ESD application in its retrospective review. The review noted only one negative side effect, ‘‘temporary discoloration of the skin that cleared up in a few minutes or days’’ (Ref. 30). However,’’temporary emotional behaviors, a temporary tensing of the body, or attempts to remove the device or grab the transmitter noted during treatment were classified as ’immediate collateral behavior’ and were not considered adverse events’’ (Ref. 30). The lead author of this article, Dr. Matthew Israel, may also have been biased in his roles as founder of JRC and Chief Executive E:\FR\FM\25APP4.SGM 25APP4 24396 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Officer of JRC at the time he co-wrote the article. In light of the foregoing, FDA believes that researchers, by current clinical and peer-review standards, likely underreported AEs. Many patients on whom ESDs have been used have limited ability to express themselves. Some earlier studies considered certain reactions that we would now consider to be AEs as mere responses or even treatment requirements. Even current researchers may classify AEs as unwanted side effects that then go unreported. For example, of the 66 patient case histories spanning 1991 through 2014 that FDA received from JRC, none reported any AEs, which is highly unusual for so many patients over such a long time (though individual exposure periods varied). Nor did any of these case histories include systematically defined methods for short- or long-term AE monitoring. Thus, even the more recent studies may still reflect outmoded standards. Significantly, because much of the relevant literature was published many years ago, it does not benefit from recent advancements in psychiatric pathophysiology that have expanded researchers’ ability to identify and record AEs. In light of the foregoing, we conclude that realized risks and dangers to individuals’ health from ESDs are likely greater than reported in the medical literature. As a result, the risks posed by ESDs reported by other sources, discussed in the following sections, warrant careful consideration. 3. Information and Opinions From Experts FDA presented the following dangers to individuals’ health related to the use of ESDs at the Panel Meeting: Negative emotional reactions or behaviors, including aggression; burns and other tissue damage; anxiety; acute stress, or PTSD; fear and aversion or avoidance; pain or discomfort; depression and possible suicidality; psychosis; and neurological symptoms and injury. The panelists generally opined that the list was incomplete, and in some cases, too vague and in need of clarification (see Ref. 68).3 One panelist noted peripheral nerve injury as a possible side effect and was surprised JRC had not reported severe depression, especially since ‘‘producing pain in people who have no control over the pain’’ is ‘‘a perfect paradigm for the learned helpless,’’ and learned helplessness is used in drug studies 3 Unless otherwise noted, all references to statements and opinions expressed at the Panel Meeting are taken from Ref. 68. VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 ‘‘because it produces in animals something analogous to depression and it can be used to test antidepressants.’’ Another panelist stated that cardiac effects, renal effects, muscle damage, and neurological symptoms, such as neuropathy, could be happening at low levels but go unreported because there has not been a systematic look at these types of potential injury over the last 40–50 years. Other panelists recommended specific additions and refinements to the list of risks and dangers, including: Equipment malfunction; long-term effects of pain; delineation of range of pain; trauma from falls; mistrust of providers; learned helplessness; chronic stress; generalized behavioral suppression; small, repetitive damage of other tissues; cognitive impairment; neuropathy; ventricular fibrillation if the electrodes are placed transthoracically; neuropsychiatric symptoms; and emotional sequelae. Several Panel members echoed the concerns discussed earlier regarding the likelihood of underreporting of AEs. For example, one Panel member pointed out that the populations treated with ESDs are very vulnerable and may not be able to self-report AEs. Panelists also indicated that because clinicians have little understanding of the breadth and the range of pain experienced by ESD patients, clinicians may mistakenly attribute adverse effects to the patients’ cognitive, intellectual, or psychiatric conditions rather than to the device. Some panelists observed that many of the risks and dangers of ESDs resemble co-morbidities in the individuals subject to treatment; as a result, adverse effects of the device would be difficult to distinguish from symptoms of the disability. This could result in AEs being misperceived as underlying symptoms, the likelihood of which is supported by the lack of systematic evaluation of AEs in the literature discussed in section II.A.2. Panel members similarly expressed concerns about communication and diagnosis difficulties exacerbating the harms experienced by patients on whom ESDs are used. In his expert report, Dr. Smith explains that ESDs for SIB or AB ‘‘necessarily involve inflicting pain on a person with [an intellectual or developmental disability],’’ and notes the risks of fear and agitation observed in one study. Dr. Smith details several limitations to the studies on ESDs in the literature, including the failure of any of the studies to have a prespecified, systematic plan for monitoring AEs, which may have resulted in underreporting of AEs. He also discusses the possibility that the PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 publication process may also introduce a bias against reporting AEs in the retrospective single-patient studies relied on by many researchers of ESDs. This is because, according to Dr. Smith, when studying only one patient, researchers tend to emphasize data that epitomize experimental control rather than an average response to the device (Ref. 8). Further, researchers generally tend to publish clear-cut results rather than less-clear outcomes (Ref. 8). Although he notes that the ‘‘overall strength of evidence is low’’ with respect to both benefit and harm, Dr. Smith concludes that ‘‘existing evidence shows that aversive conditioning with electric shock can be safe and effective in at least some cases, but that it can also be misapplied, risking severe, negative consequences’’ (Ref. 8). A comment submitted by the Disability Law Center includes a 2014 expert affidavit from Dr. James Eason, a university instructor of biomedical engineering with a Ph.D. in biomedical engineering and a B.S. in electrical engineering who has particular expertise on ICDs (Ref. 69, attachment 2). Dr. Eason opines on the potential hazards posed by three ESDs: The SIBIS (cleared by FDA in 1986), the GED–1 (cleared by FDA in 1994), and the GED– 4 (not FDA cleared or approved). Focusing on peak current, based on his views on the relationship between certain electrical stimulus parameters and pain, Dr. Easton compares the SIBIS (4.1 mA), GED–1 (30 mA), and GED–4 (90 mA), with an electrical fence (4 mA), a dog training collar (2–4 mA), and a cattle prod (10 mA), respectively. Dr. Eason opines that, when applied to non-sensitive locations such as the arm or leg, the SIBIS shock falls below the range usually considered painful; the GED–1 shock falls within the range of pain thresholds, meaning some would find it painful and some may not; and the GED–4 shock would be painful or extremely painful to anyone. According to Dr. Eason, when the electrodes are placed on sensitive parts of the body, such as hands, feet, underarms, torso, or neck, all three ESDs are capable of inflicting extreme pain on anyone. Dr. Eason explains that sweating, which may be caused by stress or anxiety about receiving a shock, lowers skin resistance, which in turn may lower one’s pain threshold, and that one’s pain threshold may also be lowered by repeated shocks. He further concludes all three devices are capable of producing tissue damage due to strong muscle contractions, and all are capable of causing superficial skin burns under certain circumstances. E:\FR\FM\25APP4.SGM 25APP4 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Dr. Eason also concludes that the ESDs ‘‘are likely to induce an immediate increase in physiological stress ranging from mild to severe. Further, the longterm effects of receiving numerous painful and uncontrollable shocks will be an increased risk for developing ASD or PTSD.’’ His conclusion is based partly on observations of people who have ICDs, which have been shown to induce psychological trauma, including PTSD, as discussed in section II.A.1. Finally, Dr. Eason believes the GED–4 presents a risk of heart palpitations, long-term psychological disorders, and neurological effects. Dr. Eason’s expert opinion is consistent with other available data and information demonstrating that ESDs can be painful, particularly when placed on sensitive areas, and that physiological and psychological factors contribute to the experience of pain. However, as explained in section I.C, because an individual’s experience of pain varies significantly based on many factors, pain predictions based on peak current are subject to considerable uncertainty. As such, although higher peak currents correspond to greater risks of physical illness or injury, the peak current is but one factor in an individual’s experience. Similarly, pain is but one risk of physical harm that ESDs pose. The devices pose serious risks of other short- and long-term psychological and physical harms, as discussed in the literature and at the Panel Meeting. 4. Information From State Agencies and State Actions on ESDs FDA reviewed complaints regarding ESD use made to the Massachusetts Disabled Persons Protection Committee (DPPC) from August 30, 1993, to July 28, 2013. Of 53 complaints, DPPC screened out 18 as not meeting complaint criteria; DPPC found 22 more were unsubstantiated. The remaining 13 complaints described the following AEs: Burns or tissue injury (6 reports), inappropriate device use (3 reports), negative emotional reactions (3 reports), and PTSD (1 report). In 2007, the Massachusetts Department of Early Education and Care (DEEC) conducted an investigation of JRC’s Stoughton Residence, where GED devices were used on individuals living there (Ref. 70). According to the Investigation Report, an individual reported waking up because his roommate was screaming; his roommate had been asleep but was shocked by a GED, waking him and causing him to scream. JRC staff reported that ‘‘the skin was off of the area’’ of the leg where GED shocks had been applied, that the VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 GED was removed from the leg ‘‘because the area on was too bad to keep the device,’’ and either the individual who received the shocks or the staff (it is not clear who) believed a stage two ulcer was in the area where skin was missing (Ref. 70). In 2006, the New York State Education Department (NYSED) conducted an onsite review of JRC’s behavior intervention programs, with purposes including identification of any health and safety issues relating to JRC’s use of aversive interventions (Ref. 71). The review was conducted by NYSED staff and three behavioral psychologists serving as independent consultants. It included a review of school policies, student records, observations of school and education programs, and interviews with staff and randomly selected individuals living at JRC. The reviewers witnessed staff rotating GED electrodes on individuals’ bodies at regular intervals to ‘‘prevent burns that may result from repeated application of the shock to the same contact point’’ (Ref. 71). During interviews, individuals reported ‘‘pervasive fears and anxieties related to the interventions used at JRC,’’ which include other interventions in addition to the GED devices. Although not reported as relating specifically to GED use, one patient stated she felt depressed and fearful, that her greatest fear was having to stay at JRC past her 21st birthday, and that she thought about killing herself every day. The review notes various other potential negative effects that may result from aversive behavioral strategies, such as depression, social withdrawal, aggression, and worsening of PTSD symptoms in individuals diagnosed with PTSD, though it did not report any specific instances of these adverse effects related to GED use. NYSED also submitted a comment to the 2014 Panel Meeting docket stating that it has received reports of collateral effects from the use of these devices, such as increases in aggression and increases in escape behaviors or emotional reactions. NYSED states it has received ‘‘numerous reports of students who have incurred physical injuries (burns, reddened marks on their skin) as a result of being shocked and for whom parents and students themselves have reported short-term and long-term trauma effects as a result of use of such devices or watching other students being shocked (e.g., loss of hair, loss of appetite, suicidal ideation).’’ NYSED believes it is well established that stress and trauma impair brain functioning. According to NYSED, one student explained, ‘‘I am scared and sometimes PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 24397 I feel like my life is in danger. There are days when I am scared to even say a word to anyone. I am afraid to wake up because I never know what is going to happen to me. I think I should not have to live in fear and be scared . . . I get so depressed here I wish my life by fast’’ (Ref. 72). 5. Information From the Affected Manufacturer/Residential Facility JRC acknowledges the risk of physical harms to the skin, that ‘‘in rare cases, mild erythema of the skin may result’’ that disappears within an hour to a few days, ‘‘less than 1% of applications result in <1 mm lesion,’’ and ‘‘it is possible that repeat exposure to the GED skin-shock could result in blistering’’ (Refs. 21 and 73). With respect to psychological adverse effects, JRC states, ‘‘there also may be brief, temporary anxiety just prior to the delivery of the application as well as occasional harmless avoidance responses (e.g., tensing of the body, attempts to remove the electrode in some cases)’’ (Ref. 21). JRC also acknowledges that, ‘‘in very rare circumstances, the GED may errantly deliver an unintended skinshock to a patient,’’ either when the shock is delivered to the wrong patient or due to spontaneous activation (Ref. 73). In line with the decades-old research that considered pain or discomfort to be merely an indicator of effective treatment (see section II.A.2), JRC does not include pain in its discussion of AEs caused by the device. Two tables provided by JRC in one of its submissions suggest its GED devices may not cause pain based solely on their peak current levels (Ref. 21). However, as discussed in section I.C, conclusions regarding pain based on peak current alone are difficult to draw, and the stimulus-pain matching tables in some of the sources cited by JRC are not based on shock sources akin to ESDs. JRC elsewhere acknowledges ‘‘the stimulation may be considered painful by some patients’’ (Ref. 73), and when asked directly whether the stimulus causes pain at the Panel Meeting, Dr. Nathan Blenkush, JRC’s Director of Research, answered ‘‘yes.’’ Except for the harms described earlier, JRC maintains that it ‘‘has not found any side effects associated with aversive conditioning’’ (Ref. 21) and ‘‘there are no confirmed reports or confirmed medical evidence that patients have any negative psychological side effects related to any discomfort experienced due to therapy with the proper use of the GED devices’’ (Ref. 73). FDA’s review of records collected as part of a 2013 inspection of E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 24398 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules JRC did not reveal any AEs reported by JRC for individuals with ESDs. A former JRC clinician commented that he ‘‘did not observe any permanent negative side effects’’ (Ref. 74). JRC concludes, ‘‘the medical literature cited by FDA [in the FDA Executive Summary for the Panel Meeting] did not show any evidence of profound, sustained, or significant harm or patient injuries resulting from use of ESDs’’ (Ref. 21). However, with respect to psychological harms, JRC’s records provide compelling evidence of risks of such harms that may result from GED use. For example, a JRC document entitled, ‘‘Procedures to Facilitate the Assessment of Possible Collateral Effects,’’ dated June 14, 2012, directs staff to note ‘‘any sign of any adverse effect on the student that may be resulting from the use of aversive interventions,’’ and ‘‘look for any collateral effects that may be related to the administration of an aversive intervention.’’ The collateral effects listed in the JRC document include, but are not limited to: Nightmares, intrusive thoughts, avoidance behaviors, marked startle responses, mistrust, depressions, flashbacks of panic and rage, anger, hypervigilance, and insensitivity to fatigue or pain. The corresponding section of the training manual headed ‘‘Responding to Collateral Effects’’ further directs staff to look for ‘‘signs of any form of distress or discomfort,’’ including but not limited to: Changes in sleep patterns, loss of appetite, confusion, irritability, lack of energy, sadness, mood swings, significant weight loss, loss of interest, fatigue and lack of energy, difficulty concentrating, agitation, restlessness, or irritability, withdrawal from usual activity, and feelings of helplessness. Another JRC document entitled ‘‘Pre-Service Training Manual,’’ dated September 11, 2012, contains the same information. Although the patient records submitted by JRC do not indicate occurrences of any of these harms, and JRC’s comments claim they adequately train their staff, monitor individuals on ESDs, and report adverse events, FDA has reason to doubt that none of these harms occurred. As discussed earlier, impairments with patient communication and provider recognition pose difficulties in identifying harms caused by the device, even for vigilant staff. State agencies in Massachusetts and New York have reported problems with staff supervision of individuals and monitoring of adverse events at JRC. For example, the 2006 NYSED review of JRC’s program found that the collateral effects of punishment ‘‘are not VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 adequately assessed, monitored, or addressed,’’ and ‘‘[t]here does not appear to be any measurement of, or treatment for, the possible collateral effects of punishment such as depression, anxiety, and/or social withdrawal.’’ Further, ‘‘[s]kin shock has the potential to increase the symptoms associated with PTSD, yet there is no evidence of data measuring these possible side effects or therapies designed to treat these symptoms’’ (Ref. 71). The 2007 Massachusetts DEEC investigation resulted in several determinations of deficiencies in patient oversight at one of JRC’s residential facilities, including lack of necessary training and experience among staff, problems regarding communication of medical issues, monitoring staff neglect of responsibilities that ‘‘compromis[ed] the supervision and the safety of residents,’’ and staff failure ‘‘to monitor the residents in a manner that assured their health and safety’’ (Ref. 70). Given these findings, patient records may well fail to capture occurrences of harms. 6. Information From Patients and Their Family Members Although three individuals formerly at JRC who spoke at the Panel Meeting either did not mention any harms or stated the GED did not harm them, two other individuals formerly at JRC described a variety of harms related to their experience with the GED, including panic and a fear of authority and being controlled, severe muscle cramps that would last 1 to 2 days, skin burn marks, terrible pain from the site of GED application on the leg down to the foot, loss of sensation in the leg and skin, frequent misfires, nightmares, freezing up upon hearing certain sounds associated with GED application, and flashbacks. Three individuals formerly at JRC interviewed by FDA clinicians asserted the following additional serious AEs resulting from GED use: Heart palpitations, seizure, depression, and suicidality. These individuals described the GED shock as ‘‘a thousand bees stinging you in the same place for a few seconds,’’ a ‘‘bad bee sting,’’ and ‘‘extremely painful,’’ and gauged the pain level from 5 to 8, depending on the GED model and the location of the shock on the body. Some of the relatives of individuals at JRC who spoke at the Panel Meeting only spoke about the positive effects of the GED devices and did not recount any adverse effects. Family members of individuals at JRC and a JRC parent association also commented that individuals at JRC have not suffered any side effects from the GED devices (see, PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 e.g., Ref. 75). However, one parent of an individual formerly at JRC described the following adverse effects from use of the GED: Burns, fear, pain, PTSD, catatonia, and deep vein thrombosis caused by catatonia. 7. Information From Other Stakeholders At the Panel Meeting, organizations concerned with the treatment and rights of individuals with disabilities cited risks of the following harms posed by ESDs based on first- or second-hand accounts: Pain, fear, anxiety, panic, depression, attempts to avoid or escape, nightmares, hyperarousal, flashbacks, burns, scars, loss of sensation, muscle contractions, learned-helplessness responses, nerve damage, muscle cramps, soreness, and neurological injuries such as seizures. The presenters stated that, in some cases, ESDs hindered the development of the very skills and behaviors necessary to control SIB or AB. The written comments from disability rights organizations, as well as health care professionals and other concerned citizens, identified the following risks based on first- and second-hand accounts of the use of ESDs: PTSD and other effects on brain function from stress, including memory loss, loss of verbal communication, and sleep pattern disturbances; severe psychological trauma; depression with possible suicidal ideation; anxiety; increase in aggression; increase in escape behaviors and emotional reactions; fear and aversion or avoidance; seizures; migraine headaches; burns or red marks on the skin; loss of hair; loss of appetite; pain; misuse of the device (misfires and erroneous applications); persistent numbness and other neurological injuries; and ear problems. One comment from a disability rights group cites a media report quoting an expert in a lawsuit filed by a parent of an individual formerly at JRC against JRC, describing the individual’s state after he was shocked repeatedly with a GED device: ‘‘He was essentially in what we would call a catatonic condition . . . That means a condition that happens with people that are acutely psychotically disturbed’’ (Ref. 76). Another comment from a psychologist, who has worked with patients exhibiting SIB and AB, reports witnessing patients waking up screaming from nightmares, which only happened after ESDs were used on them. The psychologist reported that other patients have ‘‘waking nightmares, in which horrible memories of shock, pain, and restraint suddenly overcome E:\FR\FM\25APP4.SGM 25APP4 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules them, even during an otherwise happy event’’ (Ref. 77). asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 8. Conclusion Based on the scientific literature regarding ESDs for SIB, AB, and other unwanted behaviors, and regarding aversive conditioning generally, FDA has determined that ESDs for SIB and AB present the following risks: Depression; fear; escape and avoidance behaviors; panic; aggression; substitution of other behaviors such as freezing and catatonic sit-down; worsening of underlying symptoms, such as increased frequency and bursts of self-injury; pain; burns; tissue damage; and device misapplication or failure. Based on the scientific literature regarding ICDs, FDA has determined that ESDs for SIB and AB also present the risks of PTSD or acute stress disorder, shock stress reaction, and learned helplessness. This literature also provides support for the risks of depression, anxiety, fear, and pain. Experts in the field of behavioral science and State agencies that regulate ESD use provide further support for the risks of depression, PTSD, learned helplessness, fear, anxiety, substitution of collateral behaviors, pain, burns, tissue damage, and inappropriate use. They indicate ESDs have been associated with the additional risks of short- and long-term trauma including suicidal ideation, chronic stress, acute stress disorder, neuropathy, heart palpitations, and trauma from falling. JRC’s internal policies include long lists of risks for aversives they use. Although these are not specific to ESDs, FDA finds these lists further support that ESDs pose the risks of depression, fear, anxiety, panic, learned helplessness, and substitution of collateral behaviors, and they support that ESDs are associated with the additional risks of nightmares, flashbacks, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and withdrawal from usual activity. Comments from individuals on whom ESDs have been used, their family members, disability rights groups, and others, provide additional support for the risks previously identified, and suggest ESDs may pose the additional risks of severe psychological trauma, catatonia, seizures, nerve damage, loss of sensation and numbness, migraine headaches, impaired brain function due to stress, memory loss, and muscle cramps. VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 B. Effect on Targeted Behavior 1. Scientific Literature FDA conducted an extensive, systematic review of the medical literature for information assessing the clinical benefits of the use of ESDs for SIB or AB. We identified a total of 45 studies, including 41 case reports or case series, a case-control study conducted outside the United States (Ref. 29), a within-subjects comparison trial conducted outside the United States (Ref. 78), a retrospective review of 60 patient charts (Ref. 30), and a questionnaire followup study of 22 subjects on whom ESDs were used for aversive conditioning (Ref. 79). (See table 3 of Ref. 3 for a summary of these 45 studies.) The 45 referenced studies showed that ESDs can have some immediate impact on the targeted behaviors in some patients, i.e., they interrupted the target behavior. We also evaluated 12 articles reviewing some of these 45 studies that included specific clinical information on individual subjects and examined the effectiveness of ESDs for various pathologies, e.g., AB, SIB, or problematic behaviors more generally. (See Ref. 3 for additional details.) These reviews generally support the conclusion that ESDs used on patients exhibiting SIB or AB caused the immediate cessation of the target behavior in some patients. One review article specifically examined reports of applying ESDs to autistic children (Ref. 57). The authors noted that ‘‘in all of these studies, electric shock proved to be a highly effective therapeutic agent with autistic children.’’ They estimated that positive effects compared to negative effects occurred at a ratio of 5 to 1. However, they also reported that settingspecificity (the specific setting affects the results) may be an obstacle to an overall satisfactory effect (see also Ref. 44). Similarly, a comparison of different treatments for controlling behavior in individuals with intellectual impairments or schizophrenia noted that, in terms of immediate effects, ‘‘punishment was the quickest means of suppressing behavior’’ (Ref. 80; see also Ref. 36). These studies show that ESDs can interrupt SIB or AB, causing an immediate cessation of the behavior. One study observed that a patient adapted to the stimulus intensity (Ref. 29), and another study showed that the application of ESDs can lead to adaptation (e.g., Ref. 36). Adaptation means that a patient no longer responds at a particular level of stimulation—in the case of ESDs, a particular shock strength—though the evidence is PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 24399 inconclusive as to whether this occurs. Some, including JRC, believe that adaptation occurs, and that when an individual adapts, the shock strength must be increased in an attempt to achieve the same effects. However, experts in the field, including at the Panel Meeting discussed in section II.B.3, have explained that what has been characterized as adaptation is really evidence of ineffectiveness, regardless of shock strength. Thus, for some individuals, shocks are ineffective, including with respect to immediate interruption or cessation of the target behavior. Twenty-two of the 45 literature studies reported on durability of the effects of ESDs (Refs. 29, 30, 34, 36, 39, 40, 46, 50, 65, 79, and 81–92). A durable effect is one where an individual develops a conditioned response, so the target behavior, along with the numbers of shocks, is greatly reduced either while the individual continues to wear the ESD or after the ESD is removed. Twenty of the studies reported a durable effect that lasted from months to years. Two of the 22 studies reported no durability (Refs. 50 and 92). However, all 22 suffer from various flaws and limitations, as described in the next section. Several of the literature reviews, which include reviews of many of these 45 studies, made observations regarding durability. One review opined that the use of ESDs might have long-term durability and concluded that results of aversive conditioning studies ‘‘suggest that sufficiently intense punishers . . . may produce lasting reductions in problem behavior’’ (Ref. 59). However, this conclusion included the qualifier, ‘‘as long as the punishment contingency remains in effect,’’ which implies that the authors were not discussing behavioral conditioning durability after the removal of the punisher. The authors also noted several limitations on the studies’ findings. Importantly, the available studies had methodological limitations that prevent generalizing research findings to a treatment setting (Ref. 59). One major limitation is that, because of the long duration of the studies, unplanned changes or other uncontrolled conditions hinder attributing observations to ESDs. The authors concluded that, ‘‘[u]ntil additional research on long-term maintenance is conducted, practitioners and caregivers should not assume punishment will remain effective over the long run’’ (Ref. 59). Other reviews were much more doubtful regarding the durability of ESD effects. One of the reviews discussed earlier in this subsection reported that, E:\FR\FM\25APP4.SGM 25APP4 24400 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules ‘‘[i]n marked contrast to [short-term effects], punishment and extinction programs seemed to have the least durable success’’ of any of several behavioral treatments reviewed (Ref. 80). Another review discussed earlier in this section reported that one author expressed dissatisfaction with the lack of long-term durability (Ref. 57), and another review similarly noted that the effect appeared to be short-term only, i.e., symptoms are only ‘‘momentarily suppressed’’ (Ref. 55). A more recent review found that research into durability has continued to lag (Ref. 93). See section II.C describing the state of the art for a more comprehensive explanation of the reasons that the research has lagged. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 2. Literature Limitations The medical literature described in the previous section on the effect of ESDs on SIB and AB suffers from a number of deficiencies that limit confidence in the results. Most importantly, study design deficiencies render these studies inadequate to draw any definitive conclusions. As discussed in the previous section, 41 of the 45 studies that the Agency’s analysis identified were case reports or series, which have limited evidentiary value in this patient population, as discussed in the paragraphs that follow. Another study was a retrospective analysis of patient charts (Ref. 30) that suffers from various flaws, discussed later in this section. Another study reported results from a questionnaire sent to 22 authors of case series publications, of whom only 11 responded (Ref. 79), used an unscientific sampling method (questionnaires were sent only to authors of published articles, some published more than 5 years prior), and asked questions that do not constitute validated measures of effects. The one prospective case-control study examining ESDs for SIB and AB (Ref. 29) only included 16 subjects (8 in the device group and 8 in the control group) and did not use a direct measure of SIB or AB as the primary outcome (instead, it measured a decrease in mechanical restraint). Finally, the within-subjects comparison study looked at heart rate changes as a measure of stress in five subjects, and it showed that active treatment with ESDs correlated to a statistically lower mean heart rate than when subjects were not wearing the ESD (Ref. 78). The authors surmised that heart rate was an indicator of stress but this correlation has not been demonstrated to be a valid marker of anxiety, and direct measures of reduction in SIB and AB were not taken. VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 No randomized controlled trials directly examined ESDs for SIB or AB. Generally, a study’s strength or weakness is related to design in a number of ways, particularly through randomization, control, and the number of study subjects. Randomization distributes characteristics that could affect the results evenly across conditions. This equalizes the influence of nonspecific processes not under study, e.g., the effects of participating in a study, being assessed, receiving attention, or self-monitoring. Control conditions attempt to subtract other influences to ensure observations do not have alternative explanations. They enable a comparison to a baseline in order to distinguish effects, if any, of the device being studied. A larger number of subjects provides greater confidence that the same results can be expected for any given person under the same conditions. Randomization and controls allow the researcher to determine causeand-effect, as opposed to mere coincidence, with greater confidence. As a general rule, these study design features improve the strength of conclusions, which is particularly useful in cases with potentially significant confounding factors, subtle outcomes (including AEs), or potential bias. In most cases, a study that is not randomized, controlled, inclusive of a sufficient number of subjects, or that suffers from more than one of these deficiencies, will yield weaker conclusions, and thus more uncertain predictions. Studies that fail to account for AEs will also yield weaker conclusions with respect to the benefitrisk profile, because such a study would not fully account for the risks. In the case of ESDs used for SIB or AB, randomization, control, large numbers of subjects, and AE reporting are critical to understanding the benefitrisk profile. Many factors contribute to the manifestation or reduction of target behaviors and therefore can be significantly confounding. Those factors may include, but are not limited to, the underlying condition, environmental cues, transient psychological and physical states, and the treatment plan details. ESDs used for SIB or AB may also produce subtle outcomes, especially when the individual has intellectual or developmental disabilities that can impair communication. Subtle outcomes may include, but are not limited to, the development of stress disorders, fear and anxiety, pain and suffering, or learned helplessness. In light of such circumstances, drawing conclusions about the effectiveness of ESDs for SIB PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 and AB, especially with respect to durable conditioning, is difficult in the absence of randomized controlled trials. In a randomized controlled trial, the researcher will randomly assign each subject to one group, at least one of which is a control group. A randomized controlled trial is prospective; the researcher creates different conditions across groups at the outset and will observe outcomes in the future. The researcher will eventually compare the outcomes across groups, with the control group providing confidence that the researcher-set conditions were responsible for any differences. A randomized controlled trial is one of the best designs for strong conclusions in most cases, including the use of ESDs for SIB and AB. In reviewing all the evidence, FDA did not identify any randomized controlled trials studying the effects of ESDs for SIB or AB. Other designs are often considered to provide weaker evidence, which is the case for ESDs used for SIB and AB. For example, a case-control study is usually considered to be weaker because it does not observe randomized subjects but, instead, retrospectively compares two types of subjects (one acting as the control) by observing different outcomes and working backwards to explain the cause of one set of outcomes. Retrospective reviews are often considered weaker still because they do not include a control group. Case reports or series are even weaker because they report on, and attempt to explain, the experiences of single individuals. Conclusions drawn from these other designs are generally considered weaker because they do not rule out other causes for any differences in results, including subject selection bias, as effectively. Designs that take an outcome as given and then work backwards in an attempt to explain it are more vulnerable to bias than prospective designs. Single-subject designs such as case studies are less likely to yield outcomes that would be typical for other such subjects. The conclusions drawn from randomized controlled trials are therefore generally considered much more reliable than these other designs. The general rule applies to ESDs used for SIB or AB because of the known multiple confounding factors, possible subtle outcomes (including unassessed AEs), and because bias is of particular concern. Thus, the reliance on weaker study designs for trials on ESDs limits the conclusions that may be drawn regarding their effectiveness. Other weaknesses stem from the fact that the majority of research articles E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules were published in the 1960s and 1970s. Specifically, researchers published 26 articles before 1980, 12 from 1980 to 2000, and 7 since 2000. Consequently, most of the articles do not adhere to current, more exacting peer-review standards for study conduct and reporting. This is evident not only from the time of publication but from the information provided regarding study design, conduct, and reporting. (See also section II.A.2, discussing likely underreporting of AEs.) Some of the papers have significant methodological limitations in addition to those already discussed. For example, the 2008 review by Dr. Israel and colleagues (Ref. 30), which provides a retrospective analysis of 60 subjects purporting to show all achieved successful treatment (defined as at least a 90 percent reduction in the targeted behavior), failed to explain, among other standard disclosures, data collection procedures, whether it was retrospective or prospective, and why and how staff made certain decisions that differed from patient to patient (e.g., the number of GED electrode sets applied). In short, that review did not take certain standard precautions that help to identify and eliminate bias and variability in order to understand results objectively. A 2010 review by Dr. Israel and colleagues is a series of case reports on seven individuals at JRC (Ref. 94). The authors investigated the addition of punishment-based techniques to behavioral modification plans for people for whom positive-only techniques and pharmacotherapy had been reported to have failed previously, and reported success from skin-shock treatment at JRC. A review of case reports could be useful to examine initial results for continued investigations of an intervention; however, it was retrospective and covered few subjects. The authors also failed to describe how they chose the specific case reports, meaning that the authors may have overlooked or omitted individuals for whom punishmentbased techniques did not affect the outcome. In contrast, studies that do not suffer from such methodological limitations have found that the removal of punishment techniques did not lead to an increase in problem behaviors (e.g., Ref. 95). A paper by Dr. van Oorsouw and Dr. Israel, et al. investigated the effects of GEDs, but it too suffered from significant limitations (Ref. 96). The authors claim that contingent shock (another term for aversive conditioning with ESDs) significantly improved some individuals’ behaviors; however, in each of the categories measured, no more VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 than four out of nine subjects demonstrated improvement. The other subjects ‘‘did not show any change.’’ Regarding measurements, the investigators apparently included ‘‘soft’’ neurological signs and symptoms, especially involuntary movements, which are common for individuals who exhibit SIB or AB. They apparently applied shocks for such involuntary movements even though the patients would not be able to consciously control those behaviors. The investigators also appeared to consider certain behaviors, such as refusing academic tasks, as target behaviors even though such behaviors are not clinically considered aggressive or self-injurious. Thus, the related results do not actually reflect the use of the devices for SIB or AB. Additionally, the investigators studied a small group with highly varied characteristics, e.g., intellectual capacity and primary diagnoses. Such high variability among so few patients suggests that the investigators may not have obtained results that could be generalized to other patients, even without the aforementioned deficiencies. Further, the 2008 and 2010 reviews by Dr. Israel and colleagues were published in The Journal of Behavioral Analysis of Offender and Victim Treatment and Prevention (JOBA–OVTP). JOBA–OVTP no longer appears to exist, and we determined that when it was active, it was not a peer-reviewed source because the articles were only reviewed by the journal’s editorial board rather than an expert whose sole role was to verify accuracy and validity. Failure to conduct peer review indicates that the source is unreliable because its articles were not subjected to independent expert critiques that help ensure unbiased, evidence-based conclusions. FDA also identified conflicts of interest relevant to some of the articles. While possible conflicts of interest do not on their own discredit results, certain safeguards help maintain the credibility of the authors. Authors commonly disclose possible conflicts in their papers, allowing readers to consider the information accordingly, and authors do not normally decide whether to accept their own papers for publication. However, FDA has particular concern with the bias that may have influenced many of the papers about the effects of ESDs on SIB or AB. For example, Dr. Israel, the founder of JRC, was an author of several of the 45 articles; Dr. Blenkush, the facility’s Director of Clinical Research, has coauthored several papers with him. At the time some of those papers were published in JOBA–OVTP, Dr. Israel PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 24401 was on the journal’s editorial board and thus part of the reviewing and approving body. Considering the lack of peer review of these papers, any potential bias, intentional or not, in favor of the company or Dr. Israel’s personal interests apparently went unquestioned before publication. In addition, without the expected conflict disclosures, readers were not adequately notified of any potential bias, which could affect their interpretation of the papers in consideration of the source. The evidence in the scientific literature of the effects of ESDs on individuals’ SIB or AB is therefore generally weak, and it is particularly weak with respect to the effectiveness of ESDs in achieving durable, long-term conditioning. This is not only because fewer studies considered long-term effectiveness, but more importantly, these studies failed to control for other treatment interventions applied over time, meaning that any effects observed may or may not have been due, in whole or in part, to ESDs. Thus, although the scientific literature indicates some individuals may stop engaging in the target behavior as an immediate effect of ESD application, the serious limitations discussed previously mean that durable long-term conditioning has not been established. 3. Information and Opinions From Experts The Panel Meeting convened by FDA to consider the benefits and risks of ESDs generally held opinions consistent with our review of the literature. When asked whether the evidence presented at the Panel Meeting demonstrates that ESDs provide a benefit, the Panel was divided. However, approximately half the Panel agreed that there was a benefit, but they qualified their answers by explaining that the evidence showed a benefit from the interruption and immediate cessation of the target behavior. They noted the weaknesses in the evidence, including some of the limitations discussed previously. Three panelists were undecided, with one indicating that anecdotal reports suggest benefit for an ill-defined subpopulation. About one-third of the Panel answered no, the evidence does not show that ESDs provide a benefit to patients; they cited the poor quality of the evidence, the lack of recent data, and the failure to examine long-term effects. At the Panel Meeting, one of the experts in the field observed that intervention with an aversive stimulus should not entail increasing the intensity, especially with ESDs, and that what might be characterized as adaptation or habituation to a particular E:\FR\FM\25APP4.SGM 25APP4 24402 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS shock level actually indicates that skin shock is ineffective for that individual. As he explained, ‘‘the way this whole process works is that within a given range in terms of interventions that we use, some are effective and some are not, and if they’re not effective, you go on to something else. . . . To use an analogy, a small amount of lemon juice might be another aversive event, but if that doesn’t work, we don’t put acid on the tongue.’’ With respect to ESDs, because the shock is designed to be effective very quickly, when it appears an individual has habituated to the stimulus, ‘‘it’s not really habituation; that is, they haven’t adapted to it. It’s simply ineffective, and you would move on rather than to step up the voltage, so to speak.’’ Thus, what may be characterized as adaptation to a particular ESD shock level would be evidence of ESD ineffectiveness regardless of shock level. Pointing to evidence FDA has considered, Dr. Tristram Smith’s expert opinion characterizes the results of the studies on aversive conditioning with electric shock as ‘‘highly favorable,’’ indicating that aversive conditioning reduces or eliminates severe SIB and aggression. As discussed in section II.A.3, he concludes that ESDs can be effective in at least some cases, but he is careful to note that the overall strength of the evidence is low (Ref. 8). Dr. Smith highlights many of the same evidentiary limitations discussed earlier, especially that the results may not be generalizable because they are based on small numbers of subjects and seldom provided information on key parameters, including recruitment, retention, standardization of measures, and participants’ treatment history. Dr. Smith echoes the concerns discussed earlier that the ability to reproduce the studies’ results in clinical practice is unclear because of differences between medical research and treatment settings, and notes that publication bias weighs in favor of reporting a clear effect on SIB and AB, since reports of clear effect are more likely to be published (Ref. 8). Finally, he observes that most of the few available studies have only evaluated short-term effectiveness and not longterm outcomes. 4. Information From State Agencies and State Actions on ESDs According to NYSED, in 2006 it promulgated regulations to prohibit future use of ESDs in public and private schools serving New York State students, and require review of each student who continued to receive a behavioral intervention with an aversive conditioning device by independent VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 panels of three behavior experts. NYSED reports that, ‘‘in almost every instance over a 6-year period of time, these panels have determined after reviewing student-specific information that use of such a device was not warranted.’’ The panels ‘‘consistently reported that the data presented regarding the use of an aversive conditioning device lacked evidence of effectiveness.’’ NYSED also found that the long-term use of ESDs further demonstrates the lack of efficacy. Specifically, many students remain subject to ESDs for several years, and many continue to receive shocks long into their adult lives. In 2006, NYSED documented that 17 New York citizens remained subject to ESDs for 3 to 7 years (Ref. 72). 5. Information From the Affected Manufacturer/Residential Facility JRC asserts that its ESDs provide substantial benefits to individuals by causing a meaningful decrease in the aggression, self-injury, or other harmful behaviors they exhibit, and that the literature evidences more positive side effects than negative ones. JRC representatives have stated that they have observed multiple positive side effects: The individuals ‘‘are no longer a threat to themselves or others. They are happy, they are healthy, they are medication and restraint free, and for the first time in their lives they are learning.’’ In many individuals, JRC staff ‘‘see a dramatic improvement in the affect and the way that they present. Many of them are able to receive medical treatment that they wouldn’t otherwise have been able to receive. They’re able to enjoy time with their family.’’ Regarding the effectiveness of the devices in conditioning patients’ behavior, the JRC representatives stated at the Panel Meeting that, of 83 individuals whose treatment plans included use of the GED devices, 12 no longer wear the devices, 11 additional individuals have stopped using ESDs altogether, and 6 have not received any applications in the past 6 months. The representatives gave a detailed account of an individual who they claim was successfully treated with a GED device. In their view, banning ESDs would mean many individuals ‘‘are going to go back to the state of being restrained, of losing access to education, and are going to lose access to the vocational progress they have made, and they are going to return to a life of mechanical restraint and high doses of drugs.’’ In its comments to the docket for the Panel Meeting, JRC submitted patient data purporting to demonstrate the durability of the effects of GED devices PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 in reducing or eliminating SIB and AB. However, this evidence lacks key information and provides only weak support for the durable effectiveness of ESDs. Importantly, the ESDs were part of multi-element interventions and thus were not solely responsible, if at all, for any long-term changes in individuals’ behavior. As section II.C.1 explains, multi-element treatment plans that do not involve the use of ESDs can be expected to result in durable effects (e.g., Ref. 97). Although JRC claims on its Web site that its devices are 100 percent effective (Ref. 98), at the Panel meeting JRC’s Director of Research acknowledged, ‘‘The GED and skin shock is not 100% effective for everybody . . . there are cases in the literature that show that some people it doesn’t work for.’’ He acknowledged that sometimes patients adapt to ESD shocks: [O]ne of the things that happens sometimes when you use these types of devices is that there’s a phenomenon of adaptation, which means that the skin shock device no longer functions as a punisher and the behaviors return. And that comes from using it over and over again, and the frequency of the behaviors accelerates and it no longer functions as a punisher, it no longer controls the behaviors. So when that happens, then you move—one of the things you can do is move to higher levels of stimulation . . . [W]hat JRC found in the ’90s was that if you start off at a level of 15, then you’re less likely to encounter that adaptation. And then we’ve also found that, in the rare cases where there is adaptation to the GED, we can move to the GED–4 and we generally don’t see adaptation at all after that. He later stated that JRC has ‘‘even seen adaptation to [the GED–4] in a few cases, and we’ve had to put in special protocols to help those particular people,’’ which include ‘‘a very comprehensive alternative behavior program’’ that has been ‘‘very effective’’ for at least one individual. 6. Information From Patients and Their Family Members At the Panel Meeting, a member of a JRC parent association explained that her child’s treatments were not successful until they tried JRC’s GED device. The speaker thought that the skin shock quickly and effectively targeted specific behaviors while other treatments did not stop dangerous or self-abusive actions. The three individuals formerly at JRC who expressed their opposition to a ban at the Panel Meeting described their severe behavior issues and the failures of alternative treatments. They described successful outcomes after application of GED devices at JRC, and they described how they are now independent, well- E:\FR\FM\25APP4.SGM 25APP4 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS functioning members of society and, in one case, married with children. The family members of individuals at JRC who opposed a ban described the serious SIB and AB that the individuals exhibited and the various treatments that they tried and that failed (pharmacological treatments, physical restraints, and positive behavioral interventions) prior to application of a GED device at JRC. They stated that as a result of GED application, their family members have exhibited less SIB and AB, are happier, and are improving their lives. One of the parents’ associations submitted a comment that included 32 letters from family members of individuals at JRC reporting success stories for the GED devices. One letter includes seven case reports of individuals said to have been successfully treated at JRC with ESDs. The letters contend ESDs were the only successful treatment for their family members. They describe the individuals’ severe behaviors prior to GED use, some life-threatening, including eye-gouging, suicidality, depression, swallowing sharp objects, cutting wrists, biting themselves, headbanging, hitting themselves with hard objects, running into walls, jumping out of windows, scrotal tearing, rumination, and projectile vomiting. The family members describe how previous treatments failed, leading many schools to reject or expel the individuals; in contrast, they described successful treatment with ESDs at JRC. 7. Information From Other Stakeholders One speaker at the Panel Meeting, who described himself as a doctor who worked in the field for over 25 years, said that he had published peerreviewed articles on both positive behavior support and punishment technologies. He opposes a ban ‘‘in the spirit of the right to effective treatment.’’ He believes that for some individuals, ‘‘primary salient punishment is what’s necessary in order to compete with their repertoires.’’ Several of the written comments we received from disability rights advocates assert that ESDs provide little if any benefit, and they criticize the scientific integrity of some of the sources cited by JRC in support of effectiveness. One comment from an advocate concludes that ‘‘the existing literature demonstrates only that electric shock aversives have inconsistent short-term efficacy with absolutely no long-term efficacy in reducing or eliminating destructive and self-injurious behaviors.’’ The comment criticizes the evidence relied upon by JRC to support VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 effectiveness as ‘‘published internally with the sole involvement of their own personnel or those closely connected to their facility with no meaningful external review.’’ For example, the comment states that JRC’s Web site represents a self-published followup study on 65 individuals at JRC as databased research, yet no related paper was accepted for peer review and there is no explanation or context for the methods of data collection. 8. Conclusion Our search of the scientific literature regarding the effect of ESDs on SIB and AB revealed a number of studies showing that ESDs result in the immediate interruption of the target behavior upon shock, and some of the literature also suggested varying degrees of durable conditioning. However, these studies suffer from serious limitations, including weak study design, small size, and adherence to outdated standards for study conduct and reporting. Also, the conclusions of several of the studies are undermined by study-specific methodological limitations, lack of peer review, and author conflicts of interest. There is also evidence that the shocks are completely ineffectual for certain individuals. FDA has determined that the evidence shows that ESD shocks generally interrupt and cause immediate cessation of the target behavior when applied at the onset of such behavior, but the evidence is otherwise inconclusive and does not establish that ESDs improve the underlying condition or successfully condition individuals to achieve durable long-term reduction of SIB or AB. C. State of the Art FDA considers the reasonableness of the risks of ESDs relative to the state of the art, i.e., the current state of technical and scientific knowledge and medical practice (see 44 FR 29214; May 18, 1979). 1. Scientific Literature In our systematic review of the scientific literature, FDA found that the weight of the evidence indicates the state of the art for the treatment of SIB or AB relies on multi-element positive methods, especially positive behavioral support (PBS), sometimes in conjunction with pharmacological treatments, and has evolved away from the use of ESDs. The first published studies of contingent skin shock (the stimulus delivered by an ESD) took place in the 1960s (see Ref. 3, summarizing published research). Since then, advances in science and medicine have led to a better understanding of the PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 24403 environmental triggers and organic origins of SIB and AB, improved behavior analysis methodology, and heightened ethical and human rights concerns regarding the use of ESDs, particularly in vulnerable patient populations (e.g., Refs. 99 and 100). We found that the state of the art has progressed along with these advancements, which have led to treatments that are successful in treating SIB and AB, and hold greater promise for achieving long-term results, while avoiding the risks posed by ESDs. a. Multi-element positive interventions. Elements, sometimes called components, of multi-element positive methods such as PBS, span several categories for a wide variety of purposes (e.g., Refs. 101 and 102). The term ‘‘positive’’ can apply to many different treatment modalities, such as educative programming, functional communication training, and nonaversive behavior management, but it does not include aversive interventions such as contingent skin shock (Refs. 103 and 104). Positive-intervention treatments incorporate the scientific and medical developments of recent decades as their foundation. For example, researchers have learned that behavioral treatment strategies should account for emotions and self-invalidation (rejecting the validity of one’s own thoughts or emotions), which can be underlying factors associated with challenging behaviors (e.g., Ref. 105). Relative to approaches in previous decades, multielement positive interventions broaden the scope for treatment of SIB or AB to include such factors. Pharmacotherapy (the use of medications) has similarly evolved in terms of understanding the relationship between underlying factors and SIB or AB (discussed in more detail in this section). In essence, medical approaches now treat SIB and AB as results of environmental cues and biological processes rather than subdue them through punishment-based techniques (Refs. 99 and 106). The key to creating a plan to address these cues and processes was the development of a formalized analysis, called a functional behavioral assessment (Ref. 106). Such an assessment is an analytical tool that facilitates various methods of applied behavioral analysis (ABA), which tailors treatment to the specific patient, particularly with respect to preventive measures. ABA is a fairly large family of treatment models that has existed as a general category for several decades. Although different authors define its scope differently, and older ABA models included aversives, in reviewing E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 24404 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules the state of the art, we have focused on behavioral treatment models descended from ABA that are based on current scientific and medical research. Overall, ABA and its progeny treatment models have led the treatment of SIB and AB beyond ESDs toward multi-element positive interventions, sometimes alongside pharmacotherapy, designed for the individual patient (Refs. 97, 99, and 106). To design the intervention, clinicians first conduct a comprehensive functional behavioral assessment to identify the target behaviors and the environmental and social triggers that contribute to them. This includes identifying the frequency of the unwanted behaviors as well as the social context and other environmental conditions (e.g., loud noise, crowded room) in which the behaviors are more likely to occur (e.g., Ref. 106 discussing ‘‘environmental redesign’’). Failure to conduct a functional behavioral assessment may actually lead to harm because the resulting plan may inadvertently reinforce and consequently increase the problem behavior (Ref. 107). Following the functional behavioral assessment, a behavioral treatment plan is developed utilizing a positive behavioral therapy approach, such as those discussed in the paragraphs that follow. Clinicians would ordinarily try multiple treatment interventions if the initial treatment is not successful. One particular type of positive behavioral therapy discussed in the literature is PBS. PBS uses functional behavioral assessment to develop a treatment strategy geared toward teaching new behaviors (Refs. 59, 99, and 108). These new behaviors proactively displace undesirable behaviors such as SIB and AB by teaching patients to express themselves with behavioral substitutions that will not cause harm to themselves or others. Functional communication training is one such approach. This process examines the communicative intent of the problem behaviors (what the individual is trying to tell or obtain from others), and then focuses on teaching the individual a functionally equivalent, but non-problematic, behavior (Ref. 107; see also Ref. 104). Several studies have demonstrated the value of functional communication training, especially when included as part of a comprehensive, multi-element intervention such as PBS (see Ref. 109 for a review of 29 studies). PBS also relies on reinforcing desired behaviors, altering the environment to prevent or avoid triggers, and is explicitly nonpunitive. Thus, PBS VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 treatments exclude physical aversive conditioning techniques, which react to self-injurious or aggressive behavior rather than prevent such behavior from occurring in the first place, and can often lead to the escalation of the same events they are trying to prevent (Refs. 97, 99, and 101). Although proactive in nature, PBS plans may include rapidreaction strategies for potentially serious problem behaviors that might pose a risk of harm to the subject or others to reduce the severity of an episode of problem behavior (Ref. 97). In contrast to a punishment technique, such plans are not intended to condition the individual or provide behavioral reinforcement. Another more recently developed positive-based behavioral therapy for SIB and AB is dialectical behavioral therapy (DBT). Like PBS, DBT grew out of ABA principles (Ref. 105). DBT is a cognitive behavioral treatment that was originally developed to treat chronically suicidal individuals diagnosed with borderline personality disorder, and it is now recognized as a standard psychological treatment for this population (Ref. 110). Research has shown that it is also successful in treating a wide range of other disorders such as substance dependence, depression, PTSD, and eating disorders. DBT consists of four components: A skills training group, individual treatment, DBT phone coaching, and a DBT therapist consultation team. Similar to PBS, DBT is a multi-element, empirical approach to treatment that relies on a behavioral analysis and emphasizes empathy, acceptance, and collaboration (Refs. 105 and 111). In both therapies, the goal is to impart new skills such as mindfulness, distress tolerance, interpersonal effectiveness, and emotion regulation (Refs. 105 and 111). However, because DBT was developed to treat certain conditions that may give rise to SIB and AB, such as borderline personality disorder, it differs subtly from PBS and centers on treating emotional dysregulation (Refs. 105 and 111). Thus, even though two patients may manifest SIB, DBT may be suited to treat one more than the other, depending on the underlying condition (Ref. 105). b. Evolution of the state of the art away from ESDs and toward positive interventions. During the 1960s and 1970s, aversive conditioning procedures were often used because they potentially offered a relatively easy way to immediately, if only temporarily, stop problem behaviors such as SIB or AB (Ref. 112). In one study of contingent skin shock, the authors observed that patients in treatment wards exhibiting PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 such behaviors often went untreated because of staffing inadequacies, including lack of training in reinforcement techniques (Ref. 36). In an overwhelmed ward, contingent shock potentially offered a quick fix (Ref. 36). The authors noted, however, that to get such results, they chose ‘‘a strong shock which guaranteed quick suppression,’’ one they felt was ‘‘definitely painful’’ (Ref. 36). Despite the apparent convenience, researchers have long raised ethical concerns about purposefully subjecting patients to the harms caused by physically aversive stimuli (Refs. 36 and 103). Patients subject to ESDs ‘‘gave every sign of fear and apprehension’’ associated with pain and anxiety (Ref. 36), yet decades ago, there was little oversight by human rights or behavior committees (Ref. 112). Indeed, experiments in punishment contributed to the development of behavior committees, and eventually the modern institutional review boards that are now mandatory for human research. As discussed in section II.A.1, patients may adapt to a particular shock level, which may lead to stronger shocks, thereby escalating ethical concerns (Ref. 59). Given the ethical implications, experts were cautioning as early as 1990 against allowing a crisis intervention procedure to turn into a continuous management technique (Ref. 103). Whereas ethical and human rights concerns related to the risks posed by aversive techniques, especially ESDs, were drivers of the movement in the medical community away from these techniques (Refs. 106 and 112), the rise of positive behavioral interventions appears to be attributable to their success in treating problem behaviors while posing little to no risk. The literature supports a finding that newer, positive treatment approaches that are not combined with any aversive techniques are equally successful as approaches that use both positive and aversive techniques, regardless of the problem behavior targeted (Ref. 113). Indeed, providers and researchers have found that PBS is successful in the treatment of even the most challenging behaviors (Refs. 97 and 101), including in community and home settings (Refs. 95, 114, and 115). A review of 12 outcome studies for multi-element positive interventions, for a total of 423 patients, also concluded that PBS appears to be successful for the most challenging behaviors (Ref. 97). Similarly, randomized controlled trials have demonstrated that DBT successfully reduces self-injury in patients with borderline personality E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules disorder and adolescents with SIB (Refs. 111, 116, and 117). PBS is also more adaptable than aversive conditioning techniques because it can achieve durable results for patients for whom aversive conditioning cannot. In particular, a consequential strategy such as aversive conditioning cannot achieve behavioral conditioning for some patients who have conditions that impair their ability to understand consequences and react by changing their behaviors. For example, a patient exhibiting SIB or AB may have severely impaired short-term memory and impulse control such that that any consequential strategy (like ESD shocks delivered in consequence of exhibiting a target behavior) may be limited in what it can accomplish (Ref. 97). Since PBS relies on preemptively identifying and reducing the problem behaviors’ triggers, proactively reducing the problem behavior and not reactively relying on consequences, it has an inherent advantage over aversive conditioning techniques for such patients (Ref. 97). The adaptability of PBS is also intentional, resulting from providers’ efforts to translate positive treatment outcomes that were demonstrated in clinical settings (inpatient treatment facilities) to community settings (Refs. 99 and 106). The relatively little basic clinical research on contingent shocks (shocks given in response to certain behaviors), such as those applied by an ESD, is difficult to translate into treatment plans because aversive conditioning-based techniques, including the application of ESDs, are context-sensitive and may not remain effectual in different physical environments, from different providers, or for different patients (Refs. 36, 44, 59, and 93). Further, as discussed in section II.B.2, the available evidence does not demonstrate that aversive conditioningbased techniques provide durable longterm effectiveness (Refs. 34, 36, 59, and 95). In contrast to continual application of physical aversive conditioning techniques to suppress problem behaviors, PBS can achieve durable, successful treatment in community and home settings by targeting the underlying causes of the behavior and imparting the skills needed to address it (Refs. 99 and 106). Like PBS, DBT is adaptable and has been shown to be successful in individuals with intellectual disabilities, in particular in reducing the severe SIB or AB of such individuals (Ref. 105). DBT also appears to achieve durable results after in-patient treatment (Ref. 117), and recent research suggests that, for some people, DBT approaches VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 can effectively treat SIB on an outpatient basis (Ref. 116). The only risk FDA found to be associated with positive behavioral treatments is one posed by ‘‘extinction,’’ a common, integral component of behavioral plans (Refs. 118 and 119). An extinction process reduces a target behavior by withholding the reinforcer, i.e., the response sought with the target behavior (e.g., Ref. 120). Extinction exhibits the potential risk of ‘‘extinction bursts,’’ an upsurge of the actual undesirable behavior, particularly manifested in the early stages of the intervention. If this upsurge in behavior poses a danger to the individual or others, then an extinction paradigm may not be a feasible option (Ref. 120). In general, however, positive behavioral therapies pose little to no risk to patients. Not all treatment providers follow a positive-only behavioral treatment model such as PBS (Refs. 113 and 115). As explained in section II.B.1, FDA’s review of the available data and information did reveal that aversive conditioning techniques may provide some effect of immediate cessation (e.g., Ref. 59), especially when paired with positive approaches (e.g., Ref. 113). As such, providers may believe that aversive conditioning techniques offer a viable option of last resort (Refs. 36, 99, and 112). However, the literature contains reports that when health care providers have resorted to punishers, the method was usually no more intrusive than water mist, and the addition of punishers proved no more successful than PBS-only techniques (Refs. 99 and 113). Reflecting this trend, a 2008 survey of members of the Association for Behavior Analysis found that providers generally view punishment procedures as having more negative side effects and being less successful than reinforcement procedures (Ref. 115). The comments submitted by JRC question the effectiveness of positive behavioral interventions, citing three case review studies of ‘‘positive-only’’ approaches covering successive time periods. In JRC’s characterization, a study covering 1969 to 1988 found a success rate of 37 percent for such an approach (Ref. 121), one covering 1985 to 1996 found a 52 percent success rate (Ref. 99), and the third, covering 1996 to 2000, found a 60 percent success rate (Ref. 122). JRC also cites a literature review to support its claim that positiveonly interventions sometimes require supplementation with punishment techniques (Ref. 123). These studies do not alter FDA’s conclusions regarding the effectiveness PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 24405 of positive behavioral interventions or the state of the art for the treatment of SIB and AB. We note that the first review cited by JRC (Ref. 121) includes comparative assessments of positiveonly approaches showing that, for the category of behaviors referred to by JRC (positive-only approaches targeting SIB), skills acquisition and stimulus-based interventions had 50 and 52 percent success rates, respectively, during the reviewed time period. FDA recognizes that positive behavioral interventions may not always be successful on their own for all problem behaviors in all patients. However, we note the substantial progress in non-aversive approaches for the treatment of SIB and AB as providers have gained experience with them over time, which is evident in the increasing success rates cited in JRC’s comment. Further, one review cited by JRC (Ref. 123) studied the addition of punishment procedures generally and did not address the use of ESDs in particular. Punishment procedures can take a wide variety of forms in addition to ESDs, such as daily point deductions, verbal reprimands, or food deprivation. Although the authors concluded that aversives appeared to improve some patients’ outcomes, they did not conclude ESDs were a necessary aversive, and the intervening years have yielded even more favorable results for positive-only approaches (Ref. 97). Review of the current scientific literature confirms that, in recent decades, medical practice has shifted away from restrictive physical aversive conditioning techniques such as ESDs and toward treating patients with SIB and AB with positive-based behavioral interventions (Ref. 113). PBS emerged beginning in the 1980s (Refs. 97, 106, and 112), and continued to develop in the ensuing years, emphasizing empirical analysis and applicability to non-clinical settings (Ref. 106). One analysis showed that, beginning in the 1990s, the use of positive techniques increased while the use of punishment techniques, which include physical aversives, dropped (Ref. 124). A survey of experts in the related fields of PBS and ABA found that the largest dropoff in usage of punishment techniques occurred between the 1980s and 1990s (Ref. 112). Such surveys show the ABA field as a whole moved away from intrusive physical aversive conditioning techniques such as ESDs 2 decades ago (Refs. 103 (reprinted from 1990) and 112). Correspondingly, many authors have noted that research of punishmentbased techniques—which includes a broad range of consequences, from the E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 24406 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules application of ESDs, to food deprivation, down to deducting daily points—has dwindled for decades (Refs. 59, 93, and 115). Most of the papers written since 2000 on the use of ESDs are by JRC employees and JRC consultants (Ref. 98), which raises questions regarding their impartiality, as discussed earlier in section II.B.2. Although the anecdotal reports in two of JRC’s self-authored papers purport to provide evidence of persons refractory (resistant) to all behavioral controls except ESDs (Refs. 30 and 94), these findings were not published in a peerreviewed journal, and they suffer from a number of methodological shortcomings that raise questions about their validity, as discussed earlier in section II.B.2. In direct contrast, one study that followed up on adults on whom ESDs were used in an unnamed residential facility in the northeast United States (most likely JRC) found that less restrictive interventions successfully treated SIB and AB after ESDs were removed (Ref. 95). c. Use of pharmacotherapy to treat SIB and AB. In current medical practice, the treatment of SIB and AB with positive behavioral interventions (e.g., PBS or DBT) is sometimes supplemented with pharmacotherapy. Drugs that act in the brain may provide clinical benefit, although the biochemical pathways that may contribute to SIB and AB are not well understood. SIB and AB are seen in patients with a variety of diagnoses, including autistic disorder, Fragile X syndrome, LeschNyhan syndrome, and other developmental disorders. There are currently two drugs that have been approved by FDA for the treatment of irritability associated with autistic disorder in children, a population representing a small subset of all patients with SIB and AB. RISPERDAL (risperidone) was approved in 2006 for the treatment of irritability associated with autistic disorder based on clinical trials in patients ages 5 to 17 years old, and ABILIFY (aripiprazole) was approved in 2009 for the same indication based on clinical trials in patients ages 6 to 17 years old. In the trials conducted for approval, SIB and AB were among the emotional and behavioral symptoms of autism that were measured in the overall evaluation of irritability. The most common adverse reactions observed in the trials conducted for approval of these two drugs were sedation, increased appetite, fatigue, constipation, vomiting, and drooling. Other serious adverse reactions with the use of these drugs may include VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 neuroleptic malignant syndrome, tardive dyskinesia, and metabolic changes. Published literature describes the clinical use of pharmacotherapy for the treatment of SIB and AB, which includes the use of atypical antipsychotics such as risperidone and aripiprazole as well as drugs from other pharmacological classes. (See Ref. 3 for a review of relevant literature examining the use of pharmacotherapeutic interventions in the treatment of SIB and AB.) Reports describing the use of certain atypical antipsychotic drugs (e.g., risperidone and aripiprazole) are the most common, which may be in part because safety data on their use in pediatric patients are already available and because two of them (risperidone and aripiprazole) have been approved by FDA for use in the subset of patients with SIB and AB who have irritability associated with autistic disorder. 2. Information and Opinions From Experts FDA asked the Panel whether treatment options other than ESDs, including behavioral, pharmacological, alternative, and experimental therapies, are adequate to address SIB or AB. Most of the Panel opined that other treatments are not adequate for all individuals who exhibit SIB or AB, citing a lack of sufficient data demonstrating efficacy, especially when evaluating the durability of benefits, drug side effects, and that ‘‘it’s unfortunately rare that any treatments in psychiatric or behavioral issues are universally effective.’’ FDA also asked the Panel whether a specific subpopulation of patients exhibiting SIB or AB exists for whom pharmacological and behavioral treatment options other than ESDs are inadequate. The panel unanimously concluded that such a subpopulation seems to exist but is very difficult to define and recommended additional research into refractory subpopulations. Based on the available data and information, FDA is not aware of any recognized clinical criteria to identify refractory patients. We could not find rigorous or systematically collected data that distinguish a refractory subpopulation that does not respond to other available treatments. Even assuming a subpopulation exists for which treatments other than ESDs are not adequately effective, that does not mean ESDs are effective for that subpopulation. As with other psychological or neurological conditions, there may simply be a subpopulation of patients for whom there is no adequate treatment option. PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 As discussed previously, although some evidence suggests ESDs reduce SIB and AB in some patients, no randomized controlled clinical trials have been conducted to demonstrate effectiveness generally or that ESDs are effective for behavioral conditioning when other options fail. Accordingly, the Agency agrees with the observation made by one of the Panel experts: Although other treatments may not completely reduce or eliminate SIB or AB in all patients, that does not mean ESDs should be used. In determining whether to ban these devices, FDA balances effectiveness against the risks they pose and assesses the reasonableness of such risks in light of the state of the art. The state of the art is to use positive behavioral interventions, sometimes in conjunction with pharmacotherapy, even for the most challenging SIB and AB; the unsubstantiated claim that ESDs are uniquely effective for refractory individuals does not alter that conclusion. As the Panel expert cited previously explained, ‘‘the statements of professional programs and the fact of wholesale abandonment of aversive electrical shock therapy by the peers in this field show that it is unreasonable to conclude that these devices are part of the standard of care for this class of patients . . . ’’. Epitomizing the decades-long shift away from ESDs, one of the device’s pioneers has publicly repudiated contingent shock for its lack of effectiveness (see Ref. 125). Another expert summarized in an interview that the modern clinical approach is the result of science establishing better methods, compared to ESDs, for the treatment of severe problem behaviors (see Ref. 126), and another expert repudiated behavioral treatments that use punishment techniques more broadly as early as 1989 (see Ref. 107 for a summary).4 FDA also considered information and opinions on state-of-the-art treatment for SIB and AB in the expert reports it obtained. Dr. Smith’s opinion notes similar trends that FDA has identified regarding the development of positive interventions for SIB and AB based on a functional behavioral assessment, which allows the customization of a treatment plan to meet the individual’s needs. In his view, the data do not support a precise estimate for success rates of positive interventions in patients exhibiting SIB or AB, but he notes the rapid increase in reported effectiveness, from a 1990 review that 4 Sidman, M., Coercion and Its Fallout. Authors Cooperative: 1989. E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules found a success rate of 50 percent to a recent unpublished result of 84 percent. Dr. Smith concludes that non-aversive interventions can be effective for most, but not all, people with intellectual or developmental disabilities, which is true of any such treatment (Ref. 8). Dr. Brown’s report provides additional detail on the development of the PBS field. She believes 20 years of empirical evidence demonstrate that plans designed around a functional behavioral assessment can effectively address even the most serious problem behaviors. She contrasts this evidence base with that for contingent skin shock, for which she identifies a sharp decline beginning in the 1990s. In her view, dated research on contingent skin shock is not particularly relevant to current perspectives on people with disabilities, especially given that such research does not meet modern standards for study conduct or comport with the current medical understanding of serious psychological disorders. One of the developments that Dr. Brown highlights is the understanding that the ‘‘[r]eduction of problem behavior is an important, but not the sole, outcome of successful interventions’’ (Ref. 107). Instead, an effective PBS intervention will enhance quality of life, acquisition of valued skills, and access to valued activities (Ref. 107; see also Refs. 127–129). Dr. Brown also contrasted the amount and availability of publication and training between PBS and contingent skin shock. In particular, several books and peer-reviewed journals focus specifically on PBS, and graduate training programs and organizations foster the competent development and implementation of PBS. In contrast, to her knowledge, ‘‘no journals, books, graduate programs, or organizations focus [ ] on the skills necessary to use contingent electric shock or other aversive interventions’’ (Ref. 107). Dr. Brown further points out that while no professional organization publishes standards of practices for the use of ESDs, the Association for Positive Behavior Supports has adopted standards of practice for the elements that comprise PBS (Ref. 107).5 To meet the current standards of practice, a PBS plan must: (1) Address the communicative intent of the problem behavior, e.g., with functional communication training; (2) identify and implement curricular and environmental modifications; and (3) 5 Association for Positive Behavior Supports, Positive Behavior Support Standards of Practice: Individual Level, 2007, available at http://apbs.org/ standards-of-practice.html. VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 focus on the patient’s choice and control. In Dr. Brown’s opinion, ‘‘professionals who are willing to use [contingent electric shock] are likely those that do not have any expertise in the use of PBS’’ and so would not have previously implemented plans that meet the standards of practice, reducing their likelihood of success (see also Ref. 101). Similar to Dr. Brown’s conclusions, Dr. LaVigna’s expert report also emphasizes that a positive-only treatment plan developed according to specific guidelines will adequately address even the most challenging behaviors, regardless of the individual’s diagnosis or functioning level (Ref. 130). He separates possible elements of a PBS plan into four categories: (1) Ecological strategies, which address a mismatch between the individual’s needs and the environment; (2) positive programming strategies, which teach new skills with specific instructional methods; (3) focused support strategies, which reduce or eliminate the behavior primarily through antecedent control; and (4) reactive strategies, which, unlike a punishment-based method, are intended only to reduce the immediate behavior (Ref. 130). Dr. LaVigna elaborates on the relatively recent development of a new outcome measure and principles to define challenging behaviors, including episodic severity as well as the principles of resolution and escalation (Ref. 130). Episodic severity allows a provider to account for more than the frequency of the target behavior by adding data about how severe the particular occurrence was (Ref. 130). In this way, progress can be measured more completely by including a reduction in severity, rather than merely looking at the number of occurrences. The principles of resolution and escalation allow a provider to categorize outcomes of interventions, which means they ‘‘can explicitly take responsibility’’ for strategies to achieve reductions in episodic severity (resolution) rather than increases in severity (escalation) (Ref. 130). With the advent of PBS, along with refinements such as improved outcome measures and definitions, Dr. LaVigna points to recent literature that studied over 500 patients and found that PBS was effective (Ref. 130). He also recounts an example of a patient for whom ESDs had been recommended, observing that correctly implemented positive-only methods were able to treat the patient instead (Ref. 130). He asserts that, not only is PBS highly effective even for the most challenging behaviors, but that it can be implemented in community and institutional settings PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 24407 cost effectively and accessibly (Ref. 130). He concludes that ‘‘[p]unishment is unnecessary, and is not the accepted standard of care in the relevant treatment community’’ (Ref. 130). The limited and generally outdated evidence base supporting the use of ESDs contrasts markedly with the extensive, current, and growing evidence base for PBS. While ESD use is founded upon research that incorporates outmoded assumptions and in practice has often sought compliance with staff-determined norms rather than focusing on clinically relevant behaviors, PBS reflects modern medical advancements and emphasizes patient choice, participation, and skills acquisition, even for patients with the most challenging behaviors. PBS enjoys thriving academic support and PBS practitioners can refer to practice guidelines published by a professional organization, while academic interest in aversive conditioning has languished and the use of ESDs is not contemplated in a comparable publication. 3. Information From State Agencies and State Actions on ESDs FDA considered the actions of States with respect to ESDs and aversive interventions generally, and we found that many already prohibit the use of these devices. In 2011, the Massachusetts Department of Developmental Services (DDS) proposed regulations to prohibit the use of contingent skin shock on individuals other than those who have an existing court-approved treatment plan that includes the use of such devices as of September 1, 2011.6 According to the Massachusetts DDS response to comments on its proposed regulation, 20 States as well as the District of Columbia specifically prohibit aversive interventions (Ref. 131). Massachusetts’ finalization of its regulations brings the number up to 22 jurisdictions. According to a comment from NASDDDS on the 2014 Panel Meeting, 40 States and the District of Columbia ‘‘have adopted regulations or policies that expressly prohibit the use of interventions that cause pain, are humiliating, and violate human rights.’’ These State laws prohibiting or restricting the use of ESDs provide further support that these devices are 6 Massachusetts DDS specifically addressed comments that sought an extension of the prohibition to patients with court-approved treatment plans that include the use of ESDs. However, noting the many guardians and family members of individuals receiving treatment with ESDs believe this is the only form of effective treatment for their loved ones, DDS expressed a desire not to repeat the history of extensive litigation over access to these devices (Ref. 131). E:\FR\FM\25APP4.SGM 25APP4 24408 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules not part of the state-of-the-art treatment for SIB or AB. The fact that only one site in the United States uses ESDs on individuals with SIB or AB (Ref. 73), and that the individuals subject to ESDs are predominantly from two States, and from fewer than a dozen in total,7 strongly suggest the overwhelming majority of patients exhibiting SIB and AB throughout the country are being treated with methods that do not involve ESDs. Given that, as discussed in section I.B, at least 330,000 individuals in the United States exhibit SIB or AB, JRC (with fewer than 300 residents) observes a very tiny fraction of all such individuals. In fact, the Massachusetts DDS has successfully transitioned several patients who were subject to ESDs at JRC to providers who do not use ESDs (Ref. 132; see also Ref. 95). FDA agrees with the assessment of the current standard of care by the Massachusetts DDS: asabaliauskas on DSK3SPTVN1PROD with PROPOSALS The Department concludes that there has been an evolution in the treatment of severe behavioral disturbances in persons with intellectual disability over the past thirty years, and particularly in the last two decades, which has moved towards forms of treatment that are non-aversive and involve positive behavioral supports. The Department bases this opinion both on the body of empirical evidence showing the effectiveness of other less intrusive forms of treatment that do not involve pain; on the overwhelming support of this position by virtually every local, statewide or national organization supporting individuals with intellectual disability, and by providers and clinicians whose practice demonstrates that non-aversive treatment can modify difficult or dangerous behaviors effectively and for the long-term, while aversive interventions, in addition to causing pain and anxiety in such individuals, have no proven long-term efficacy. (Ref. 131; see also Ref. 132.) Evidence from other States further corroborates our conclusions. For example, as discussed earlier, according to NYSED, following promulgation of regulations in 2006 by NYSED prohibiting future introduction of ESDs in public and private schools and requiring review of students then subject to ESDs, independent panels of behavior experts determined that ESDs were not warranted in almost every instance over a 6-year period. Similarly, at the Panel Meeting, the Assistant Attorney General for the State of Utah, representing his State’s agencies that 7 Although JRC stated at the Panel Meeting that it serves patients from 11 States, according to one of JRC’s comments, the 82 patients on whom GED devices had been used as of April 2014 are from only 6 States, and 60 of them are from either New York or Massachusetts (Ref. 21). VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 provide services and protection for individuals with disabilities, observed that programs in Utah and across the nation effectively treat SIB and AB without ESDs. 4. Comments From the Affected Manufacturer At the Panel Meeting, the presenters for the manufacturer stated that the data demonstrate a clear clinical need for these devices. In their view, therapy for these individuals has failed at all other treatment centers, and other treatments have failed at JRC prior to the utilization of their GED devices. They asserted that a wide range of therapeutic interventions over long periods of time have been ineffective for their residents on GED devices, and that typically 12 to 15 other facilities have expelled or rejected these residents before they come to JRC. They stated that the individuals on whom ESDs are used are those with extraordinary behavior disorders. JRC’s position is that few other treatment facilities, if any, will accept patients who have not improved without aversives, and that the only other options besides ESDs would be psychotropic drugs and various restraints (Ref. 21). FDA has found no basis to believe that the patients on whom ESDs are used at JRC are patients with the most severe SIB and AB in the United States. FDA also has reason to doubt whether all alternatives were adequately attempted before resorting to ESDs. As noted in section II.C.5, we are aware that some parents have reported that JRC did not attempt positive approaches based on functional behavioral assessments, and the parents felt pressured into accepting the necessity of ESDs (Ref. 133). Similar to the NYSED review discussed in sections II.A.4 and II.B.4, another review revealed that the facility using ESDs for SIB and AB either did not conduct a functional behavioral assessment or did so in a non-standard way, which could reduce the effectiveness of the resulting behavioral intervention (Ref. 107). Although there is anecdotal evidence that treatments other than ESDs were tried on individuals at JRC and failed prior to use of ESDs, there is evidence in the literature that patients have been successfully treated with alternatives after ESDs were used (Ref. 95). Further, evidence of failures of treatments other than ESDs is not evidence that ESDs safely or successfully treat patients or are within the state of the art. To cope with patients’ apparent adaptation, the manufacturer itself acknowledges that increasing the electric current may be PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 necessary, and if that does not work, the ESD may need to be replaced with ‘‘an alternative behavior program’’ (Ref. 21). In fact, consistent with our understanding of the state of the art, JRC touts positive behavioral therapies, for example on the ‘‘Unparalleled Positive Programing’’ page on its Web site, but its Web site does not even mention its use of ESDs (Refs. 134 and 135). The comments submitted by JRC question the effectiveness of positive behavioral interventions based on its belief that there does not appear to be any clinical data supporting such, an absence of research concluding that ‘‘all problem behaviors can be effectively treated using only PBS procedures,’’ and ‘‘literature stating that PBS is not always effective for self-injurious behaviors.’’ The comment from a former JRC clinician also asserts that PBS and medications are not effective for all individuals with serious behavior disorders. Contrary to JRCs assertion, there are clinical data supporting the effectiveness of positive behavioral interventions such as PBS and DBT in treating SIB and AB, as discussed earlier in this section. Further, even though positive behavioral interventions may not always be successful on their own for all problem behaviors in all patients, this does not mean they are not generally effective, sometimes used in conjunction with pharmacotherapy, or that they are not state-of-the-art treatments for SIB and AB. Rather, the literature provides evidence showing that multi-element positive interventions are at least as successful as methods that include use of aversives regardless of the behavior targeted, as discussed earlier in this section. JRC also submitted a paper by Dr. Blenkush, the Director of Clinical Research at JRC, purporting to show that ESDs have a more favorable side effect profile than antipsychotic medications (Ref. 21). FDA notes that no peerreviewed literature compares treatment regimens. Further, the JRC paper makes comparisons that may not be relevant to the selection of treatment for an individual. For example, the paper compares frequency of specific side effects from pharmacotherapy to the frequency of different categories of side effects from ESDs. However, aggregate frequency data on dissimilar effects across different patient populations provide scant basis for a comparison of treatment regimens. Comparing a comprehensive list of the side effects of several antipsychotic medications against the side effects of a single device, which the paper admits ‘‘have not been evaluated in the same depth or E:\FR\FM\25APP4.SGM 25APP4 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS with as many participants’’ (Ref. 21), does not represent a valid comparison. The comment from a former JRC clinician asserts the standard of care for treatment resistant individuals such as those at JRC includes consideration of aversive conditioning devices such as the GED, citing a textbook that discusses punishment techniques including the use of ESDs.8 FDA notes that the cited chapter reviews information on the SIBIS, not the GED, and except for a SIBIS case report, the chapter relies on pre-1990 studies. Furthermore, it concludes with the observation that electric shock is usually not necessary and can be replaced with ‘‘more acceptable aversive outcomes’’ such as a squirt of lemon juice or a reprimand. This evidence does not demonstrate that ESDs are currently considered by the scientific and medical community to be an acceptable option for patients exhibiting SIB and AB. 5. Comments From Patients and Family Members of Patients The three former JRC residents who opposed a ban at the Panel Meeting described their severe behavior issues and the failures of alternative treatments (psychotropic medications, physical restraints, and reward systems). One stated that the drugs made him feel like ‘‘a walking zombie.’’ Comments from family members of JRC residents similarly describe numerous failed alternative treatment attempts prior to finding success with ESDs at JRC. Many family members report that the side effects of drugs are much worse than ESDs and included: Extreme sedation, not recognizing or interacting with others, bizarre behavior, toxicity effects (such as damage to internal organs), loss of personality, and lack of learning. One parent listed 26 drugs her child had tried and other treatments that failed, including electroconvulsive therapy (which is different from ESD application and not the subject of this proposed rule). One mother noted that the behavior medications interacted with her child’s seizure medications and caused an increase in seizures. FDA understands that family members of individuals exhibiting SIB or AB face very difficult choices regarding treatment options, and FDA does not doubt their best intentions, the sincerity of their belief that an ESD is the best or perhaps only option for their loved one, or that they have tried alternative treatments without success. However, FDA does have reason to 8 Malott, R.W. and J.T. Shane, ‘‘Punishment (Positive Punishment),’’ in Principles of Behavior. 7th ed. 2013, Boston, MA: Pearson. VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 question the information provided to these family members by JRC. One article reports that some parents who consented to the use of GEDs on their children did so only under pressure (Ref. 133). These parents reported feelings of coercion upon admission to the facility and intimidation when attempting to change their children’s intervention plans (Ref. 133).9 The parents reported facing a choice between restrictive aversive strategies justified as measures of last resort, such as between the GED and use of a fourpoint restraint board, and chose the GED as the lesser evil (Ref. 133). Although the facility touts itself as accepting refractory patients, all of the parents interviewed provided information suggesting that interventions in public schools prior to JRC admission did not attempt all treatment options, such as using a functional behavioral assessment to develop prevention or antecedent strategies (Ref. 133). Once at JRC, none of the parents reported the development of prevention or antecedent strategies for their children (Ref. 133). Given that functional behavioral assessments, as well as prevention and antecedent strategies such as those in a positive multi-element intervention, are generally successful even for challenging SIB and AB, such patients may well have been responsive to PBS techniques had they been attempted. FDA acknowledges that these reports are only from certain parents who volunteered to share negative experiences, and we cannot conclude that these reported experiences were shared by others or are generally representative of families’ experiences at JRC. Nevertheless, the reports do indicate that at least some parents felt pressured by JRC to continue to agree to the use of GEDs on their children, and for at least some children, alternative treatments were not exhausted. For them, GEDs were not in fact applied as a last resort. 6. Comments and Information From Others Information from other Federal agencies, behavioral psychologists, disability rights groups, and the United Nations corroborates FDA’s conclusions regarding the risks of ESDs relative to the state of the art. For example, in its comment, the U.S. Department of Justice (DOJ) explained that it has concluded that ESDs are outside the generally 9 The authors do not identify the facility by name. However, they are clear that the ESD in question was the GED, refer to JRC’s Web site, and rely on an article about JRC when characterizing the facility. PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 24409 accepted standard of care (Ref. 136). DOJ enforces the Civil Rights of Institutionalized Persons Act (42 U.S.C. 1997 et seq.), which entitles eligible patients to receive services that meet generally accepted standards of care. In order to protect that right, DOJ must determine relevant standards of care, giving DOJ experience in comparing treatment to that which providers generally accept as the standard. In DOJ’s view, far from the standard of care, ESDs are physically and psychologically harmful punishments that have uncertain efficacy. According to DOJ, the current, generally accepted professional standards of care for individuals with intensive behavioral needs require PBS, implemented according to individualized plans, and not restrictive methods such as ESDs. DOJ asserts that thousands of people throughout the country with similar behavioral needs receive effective treatment without being subjected to the risks posed by ESDs. Behavioral psychologists who have practiced for decades treating patients with SIB and AB indicated in comments on the Massachusetts ban that they have not had to resort to aversives such as ESDs, describing painful aversives as ‘‘unnecessary, unacceptable, and not supported by the professional literature’’ (Refs. 137 and 138). Another commenter on the Massachusetts ban stated that in 30 years working in programs serving individuals with severe behavior challenges and dangerous behavior in more than 20 States, no program allowed use of pain to control behavior (Ref. 131). At the Panel Meeting, disability rights groups’ presentations concurred that positive behavioral interventions have been shown to result in long-term reduction or elimination of challenging selfinjurious or aggressive behaviors. Finally, the United Nations Special Rapporteur on torture and other cruel, inhuman, or degrading treatment or punishment, has determined that the application of ESDs violates the rights of individuals at JRC under the United Nations Convention Against Torture, as well as other international standards, and supports a complete ban on ‘‘electroshock procedures.’’ Although the United Nations is composed of many countries in addition to the United States, the fact that this multination body does not merely consider ESDs to be inappropriate or unacceptable treatment, but considers them to constitute torture, suggests that there is great distance between these devices and state of the art for treatment of SIB and AB. Although JRC claims ESDs are used for SIB and AB in other E:\FR\FM\25APP4.SGM 25APP4 24410 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules asabaliauskas on DSK3SPTVN1PROD with PROPOSALS nations, it has not provided any examples, and FDA is unaware of one. and the success rates continue to improve. 7. Conclusion FDA has determined, on the basis of all available data and information, that state-of-the-art treatments for SIB and AB are positive-based behavioral approaches, sometimes alongside pharmacotherapy, as appropriate, and do not include ESDs. We focused on data in the scientific literature, current clinical practices, and information about the evolution of treatments for SIB and AB. Significant scientific advances have yielded new insights into the organic causes and external triggers of SIB and AB. Although researchers have much yet to learn, the advent of functional behavioral assessment, and, subsequently, approaches like PBS and DBT, have allowed providers to move beyond aversive conditioning techniques such as the contingent shocks delivered by ESDs. The state of the art represents the achievements of an empirical response to the inadequacies of such techniques from both a safety and effectiveness standpoint. The scientific community has long recognized that addressing the underlying causes of SIB or AB, rather than suppressing it with painful shocks, not only avoids the risks posed by ESDs, but can achieve durable, long-term benefits. As a result, the use of aversive conditioning techniques overall, and ESDs in particular, has diminished considerably over the past several decades, while the use of positive behavioral methods has risen. The overwhelming majority of remaining providers who employ some type of aversive conditioning use methods that are much less intrusive than contingent shock. ESDs are only used at one facility in the United States on individuals from a small number of States; almost half of the States have specifically prohibited their use. Practitioners in the field with decades of experience have asserted that they have never had to resort to ESDs, and surveys of experts show that such views are common. Meanwhile, modern positive behavioral treatments have been demonstrated to work in complex environments like community settings and achieve durable results while posing very little risk (Refs. 99, 101, and 106). Although positive behavioral interventions such as PBS may not always be completely successful on their own for all behaviors in all patients, the literature indicates that they are generally successful, sometimes alongside pharmacotherapy, regardless of the severity of the behavior targeted, III. Determination That ESDs for SIB and AB Present an Unreasonable and Substantial Risk of Illness or Injury As discussed in section I.F, section 516 of the FD&C Act authorizes FDA to ban a device intended for human use by regulation if it finds, on the basis of all available data and information, that such a device presents substantial deception or an unreasonable and substantial risk of illness or injury. In determining whether a deception or risk of illness or injury is ‘‘substantial,’’ FDA will consider whether the risk posed by the continued marketing of the device, or continued marketing of the device as presently labeled, is important, material, or significant in relation to the benefit to the public health from its continued marketing (see § 895.21(a)(1)). With respect to ‘‘unreasonable risk,’’ FDA analyzes the risks associated with the use of the device relative to the state of the art (44 FR 29214 at 29215). Thus, in determining whether a device presents an ‘‘unreasonable and substantial risk of illness or injury,’’ FDA analyzes the risks and the benefits the device poses to patients, comparing those risks and benefits to the risks and benefits posed by alternative treatments being used in current medical practice. Actual proof of illness or injury is not required; as Congress explained when it amended the medical device banning provisions in the FD&C Act, FDA need only find that a device presents an ‘‘unreasonable and substantial risk of illness or injury’’ on the basis of all available data and information (H. Rep. 94–853 at 19; 44 FR 29214 at 29215). FDA has considered evidence from a wide variety of sources, including the scientific literature, experts in the field, State agencies that also regulate ESD use, the affected manufacturer/ residential facility, individuals on whom ESDs have been used and the views of their family members, disability rights groups, and other government entities. In weighing each piece of evidence, FDA took into account its quality, such as the level of scientific rigor supporting it, the objectivity of its source, its recency, and any limitations that might weaken its value. Thus, for example, we generally gave much more weight to the results of a study reported in a peer-reviewed journal by an objective author than we did to anecdotal evidence. As discussed in section II.A, the scientific literature demonstrates that ESDs for SIB and AB pose a number of psychological harms including VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 depression, PTSD, anxiety, fear, substitution of other negative behaviors, worsening of underlying symptoms, and learned helplessness, as well as the physical risks of pain, and skin burns. These risks are not exclusive, and their harmful impact is magnified when an individual experiences two or more of them together. Misapplications of shocks present the same risks without any possibility of benefit. FDA determined that AEs have very likely been underreported due to various methodological limitations in the scientific literature as well as the impaired ability of many subjects to recognize and communicate AEs, which also increases the risk of harm to these individuals. Because of the likely underreporting of AEs in the literature and the fact that actual proof of harm is not required, FDA carefully considered the risks identified through other sources, which provide further support for the risks reported in the literature and indicate that ESDs are associated with additional risks such as suicidality, chronic stress, neuropathy, and injuries from falling. Although JRC has only publicly acknowledged the risks of pain and erythema, JRC’s own records provide compelling evidence that aversive interventions such as ESDs are associated with several other risks, including nightmares, flashbacks of panic and rage, hypervigilance, insensitivity to fatigue or pain, changes in sleep patterns, loss of interest, difficulty concentrating, and withdrawal from usual activity. As discussed in section II.B, the studies reported in the scientific literature show that ESDs can immediately interrupt SIB or AB upon shock, and some studies suggest varying degrees of durable conditioning. However, the studies in the literature suffer from various limitations, such as weak study design, including failure to control for concomitant treatments, small size, other methodological limitations, lack of peer review, and author conflicts of interest. As a result, the evidence is inadequate to establish that ESDs improve individuals’ underlying conditions or successfully condition individuals to reduce or cease the target behavior to achieve durable long-term reduction of the target behavior. Further, to the extent ESDs do cause immediate interruption for some, the evidence also suggests that the shocks are completely ineffective for others, regardless of shock strength. Regardless of whether adaptation is the correct characterization, even JRC has acknowledged that its strongest ESD sometimes becomes ineffective, E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules necessitating the use of an alternative behavior program instead of an ESD. As discussed in section II.C, FDA has determined that state-of-the-art treatments for SIB and AB are positivebased behavioral approaches along with pharmacotherapy, as appropriate, and do not include ESDs. The medical community now broadly recognizes that addressing the underlying causes of SIB and AB, including environmental ones, rather than suppressing behaviors with shocks not only avoids the risks posed by ESDs, but can achieve durable, longterm benefits. As a result, research about and use of aversive conditioning techniques overall, and ESDs in particular, has diminished considerably over the past several decades, while research about and use of positive behavioral methods has increased and continues to increase. ESDs are only used at one facility in the United States with individuals from a small number of States. Almost half of the States prohibit ESD use, and there is evidence that the overwhelming majority of patients exhibiting SIB and AB throughout the country are being treated without the use of ESDs. Although positive behavioral interventions such as PBS may not always be completely successful on their own for all behaviors in all patients, the literature shows that they are typically successful (on their own or in conjunction with pharmacotherapy), regardless of the severity of the behavior targeted, even in community settings, and can achieve durable long-term results while avoiding the risks posed by ESDs. FDA has determined that the risks posed by ESDs for SIB and AB are important, material, or significant in relation to the benefit to the public health from their continued marketing. FDA recognizes that ESDs can cause the immediate cessation of self-injurious or aggressive behavior; however, the immediate effects the ESDs provide are outweighed by the numerous short- and long-term risks discussed earlier in this section. For many individuals who exhibit SIB or AB, these risks are magnified by their inability to adequately communicate the harms they experience to their health care providers. Even when immediate cessation is achieved, without durable conditioning the target behavior will recur over time and necessitate ongoing shocks to cause immediate cessation, magnifying the risks. If adaptation occurs, it would render the shocks wholly ineffective and could lead to stronger shocks with no effect. Thus, the degree to which the risks outweigh the benefits increases over time. VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 FDA has also considered the risks posed by ESDs for SIB and AB relative to the state of the art. Decades ago, health care providers had a poor understanding of the causes of SIB and AB and very limited options to treat SIB or AB. Contingent skin shock was used even though the result was fleeting and continual shock administration was needed. Since then, state-of-the-art treatment for SIB and AB has evolved considerably. Today we know that careful functional assessment, which identifies specific unwanted or undesired behaviors, the frequency and severity of these behaviors, and their specific triggers, allows for the development of positive-based behavioral therapy that provides greater benefit and poses less risk than using ESDs. Although they may demand more health care provider training and effort than ESDs, various multi-element positive interventions such as PBS and DBT are now very much viable options for treatment of SIB and AB. These interventions pose little risk and, on their own or alongside pharmacological treatments, have been shown to be successful in treating even the most severe behaviors in both clinical and community settings, and to achieve durable long-term results. Several individuals have been successfully transitioned from ESDs at JRC to positive-based therapies elsewhere. Thus individuals exhibiting SIB or AB have alternative options to ESDs that pose less risk and provide greater benefit through durable longterm effectiveness in both clinical and community settings. Based on a careful evaluation of the risks and benefits of ESDs for SIB and AB and the risks and benefits of stateof-the-art treatments for SIB and AB, FDA has determined the risk of illness or injury posed by ESDs for SIB and AB to be substantial and unreasonable. A majority of the expert Panel also found that ESDs for SIB and AB present a substantial and unreasonable risk of illness or injury. The Panel members who opined that this standard is not met generally had concerns about foreclosing the possibility that new ESDs may be developed in the future and used in a way that can safely and effectively treat SIB and AB. In this regard, FDA notes that a banned device is not barred from clinical study under an investigational device exemption pursuant to section 520(g) of the FD&C Act. However, any such study must meet all applicable requirements, including but not limited to, those for: Protection of human subjects (21 CFR part 50), financial disclosure by clinical investigators (21 CFR part 54), approval PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 24411 by institutional review boards (21 CFR part 56), and investigational device exemptions (21 CFR part 812). Other panelists were reluctant to agree that the banning standard had been met because it could be possible to develop ESDs to treat SIB or AB without being noxious. In response to these concerns, FDA notes that devices that are not noxious are not within the scope of this ban. Other than JRC and the former JRC clinician, the only comments in opposition to a ban either at the Panel Meeting or through submission of comments to the Panel Meeting docket were from three former JRC residents, family members of individuals on whom ESDs were used at JRC (one of the parents association comments included 32 letters from family members), a Massachusetts State Representative, and one concerned citizen. As discussed earlier, FDA recognizes that family members of individuals now and previously on ESDs at JRC have had to make some very difficult decisions regarding the care of a loved one, and FDA does not doubt their intentions or question the sincerity of their belief that ESDs are the best or only option available. However, as discussed in section II.C.5, FDA has reason to believe at least some of these family members were pressured into choosing ESDs, and FDA questions whether these family members were provided with full and accurate information regarding the risks and benefits of ESDs and alternative treatment options, and whether all other options were adequately attempted prior to ESD use. IV. Labeling FDA has determined that labeling, or a change in labeling, cannot correct or eliminate the unreasonable and substantial risk of illness or injury. At the Panel Meeting, only members who opined that ESDs present an unreasonable and substantial risk of illness or injury (a majority of the entire Panel) were asked whether labeling could correct or eliminate this risk, and all concluded that labeling could not correct or eliminate the risks or dangers. As explained in section II.A, the risks posed by ESDs fall under two broad categories, psychological and physical, and these risks are heightened when the devices are used to treat patients who exhibit SIB or AB because of these patients’ vulnerabilities. As explained in sections I.C and II.A.1, individuals demonstrate great variability in their experience of ESD shocks, including with respect to pain and the psychological harms discussed. A person’s physical state naturally E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS 24412 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules changes continuously, so the body’s reaction to ESD shocks will change continuously, and a person’s mental state further shapes the experience. The same electric shock, as characterized by electrical current and stimulation site, may affect any given person in a variable manner from one shock to another. This variability is seen across different individuals, which prevents providers from using one person’s experience as a guide for another person, and within the same individual over time, which prevents providers from using a single person’s past experience as a predictor of future experiences. Labeling cannot correct or eliminate the risks or dangers because conditions under which providers could overcome the underlying inter- or intrapersonal variability cannot be defined. Predicting an individual’s resulting experience would require knowing the initial psychological and physical states of the person, which is subjective information that providers cannot reliably know, especially when making a split-second decision whether to apply a shock. Further, individuals, especially ones with intellectual or developmental disabilities, may not be able to accurately and reliably communicate information regarding their physical or psychological state. Thus it would be impossible to create broadly applicable labeling that could account for these variables; labeling could only warn the provider that it is impossible to account adequately for all relevant factors. Because labeling cannot correct or eliminate the fact that providers lack knowledge required to mitigate the risk of harm, it cannot correct or eliminate the risks or dangers posed by ESDs for SIB or AB. Labeling also cannot correct or eliminate ESD risks or dangers by specifying output parameters, for example, maximum current or optimal electrode placement. As explained in section II.A.1, the subjective experience, especially in terms of psychological harms, does not necessarily vary in proportion to shock strength. Even a relatively mild stimulus can trigger or contribute over time to a more serious psychological reaction (e.g., Refs. 31– 33). Thus it would not be possible to provide warnings regarding output parameters to correct or eliminate the risks and dangers. Labeling also cannot limit the risks to only the most refractory patients. As explained, although evidence indicates that a subpopulation of refractory individuals may exist, that subpopulation is difficult if not impossible to define. The labeling of the VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 GED devices, the only ESDs currently in use in the United States of which FDA is aware, already includes the statement that ‘‘[t]he device should be used only on patients where alternate forms of therapy have been attempted and failed.’’ Yet the available evidence, discussed in section II.C.5, casts doubt on whether JRC in fact applies the devices as a last resort after attempting all other approaches, and shows that patients JRC considered to be refractory were transitioned successfully to other treatments. Thus labeling has failed to limit use of the device to patients who do not have other adequate treatment options. Further, even if a refractory subpopulation could be defined, as discussed in section II.C.4, the possibility that some patients are refractory to treatment does not necessarily mean that ESDs would be an effective treatment or that the benefits of ESD use outweigh the risks. Thus labeling cannot correct or eliminate the substantial and unreasonable risk posed by ESDs. In his report, Dr. Smith recommends against banning and that FDA should instead impose the following restrictions: ‘‘(1) A prescription and ongoing, periodic review by a boardcertified physician, licensed psychologist, or licensed behavior analyst and (2) prior approval and ongoing, periodic review by an independent patient-rights committee convened by a healthcare organization that is accredited by an organization such as the Joint Commission.’’ Although FDA does not have to consider whether restrictions would obviate the need for a ban, we have considered Dr. Smith’s proposal and do not believe restrictions would correct or eliminate the substantial and unreasonable risk posed by ESDs. The only ESDs currently in use are prescription devices and, as explained by JRC, ‘‘require multiple levels of review, approval, consent and oversight.’’ FDA has determined that JRC’s measures do not adequately mitigate the unreasonable and substantial risk posed by these devices. While the measures Dr. Smith recommends are perhaps stronger, there is not enough information to determine that such measures would adequately mitigate the risks. V. Application of Ban to Devices in Distribution and Use FDA is proposing that the ban apply to devices already in commercial distribution and devices already sold to the ultimate user, as well as devices sold or commercially distributed in the future (see § 895.21(d)(7)). This means PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 ESDs currently in use on individuals would be subject to the ban and thus adulterated under section 501(g) of the FD&C Act and subject to FDA enforcement action. FDA is proposing this because the risk of illness or injury to individuals on whom these devices are already used is just as unreasonable and substantial as it is for future individuals on whom these devices could be used. Indeed, as safer and more effective alternative treatments continue to be developed, it is the individuals on whom ESDs are currently used for whom the ban may have the most impact. The majority of the Panel agreed that, if FDA were to ban ESDs, the ban should apply to devices already in use. JRC believes that any action ‘‘that would precipitously remove or require the eventual removal of the GED from the patients who currently rely on this court-ordered therapy would have dire consequences from a patient safety and health perspective’’ (Ref. 21). According to JRC, the GED ‘‘is the only treatment available to these patients’’; all others were tried and failed. As an example of what could result from a mandated, sudden removal of the GED from a patient, JRC explains that one patient whose GED was removed against the medical advice of JRC health professionals soon resumed selfinjurious scratching and picking behaviors that led to serious blood and bone infections, paralysis of his legs, and eventual death 3 years after leaving JRC (Ref. 139). As discussed in section II.C, FDA does not agree that ESDs are the only treatment available for individuals exhibiting SIB or AB, no matter how severe the behavior may be, and FDA has reason to doubt whether all other treatment options were attempted for individuals prescribed these devices. FDA has not been able to verify the accuracy of JRC’s account regarding an individual removed from the GED. However, even if accurate, that does not mean that the GED was not harmful to the individual, nor does it speak to the extent to which other treatments were tried after he left JRC. The only support JRC offers for this anecdote is a post on its Web site by Dr. Israel that does not include information regarding possible harms from GED use or details regarding treatment after the patient left JRC, and JRC states it offered the post as an editorial to the New York Times but was rejected. In contrast to JRC’s assertions, we again note that one study described in the literature found that less restrictive interventions successfully treated SIB and AB in individuals after ESDs were removed (Ref. 95), and that E:\FR\FM\25APP4.SGM 25APP4 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules Massachusetts DDS has successfully transitioned several patients who were subject to ESDs at JRC to providers who do not use ESDs (Ref. 132). However, FDA recognizes that, for certain individuals currently subject to ESDs, immediate cessation could possibly result in a significant increase of SIB or AB before appropriate alternative therapies are in effect, and a more gradual reduction toward complete removal may be necessary for some patients, especially those who have been subject to ESDs for a considerable amount of time. Thus, to account for this possibility, in appropriate circumstances, FDA does not intend to enforce the ban for a limited period of time with respect to ESDs that continue to be used on patients after the effective date. We intend to consider, for example, whether the patient has a documented medical need for gradual transition to an alternative therapy, as determined by an independent psychiatrist, psychologist, or similar State-licensed behavioral expert. We welcome comment on how long transitions may take. FDA does not intend to enforce against individual patients. asabaliauskas on DSK3SPTVN1PROD with PROPOSALS VI. Proposed Effective Date FDA is proposing that any final rule based on this proposed rule become effective 30 days after the date of its publication in the Federal Register. FDA requests comment on the proposed effective date for this proposed rule. VII. Analysis of Environmental Impact FDA has carefully considered the potential environmental effects of this proposed rule and of possible alternative actions. In doing so, the Agency focused on the environmental impacts of its action as a result of disposal of unused ESDs that will need to be handled after the effective date of the proposed rule. The environmental assessment (EA) considered each of the alternatives in terms of the need to provide maximum reasonable protection of human health without resulting in a significant impact on the environment. The EA considered environmental impacts related to landfill and incineration of solid waste. The proposed action would result in an initial batch disposal of used and unused ESDs primarily at a single geographic location followed by a gradual, intermittent disposal of a small number of remaining devices in this and other affected communities where these devices are used. The total number of devices to be disposed is small, i.e., approximately less than 300 units. Overall, given the limited number of VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 ESDs in commerce, the proposed action is expected to have no significant impact on landfill and solid waste facilities and the environment in affected communities. The Agency has concluded that the proposed rule would not have a significant impact on the human environment, and that an environmental impact statement is not required. FDA’s finding of no significant impact (FONSI) and the evidence supporting that finding, contained in an EA prepared under 21 CFR 25.40, may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. FDA invites comments and submission of data concerning the EA and FONSI. VIII. Economic Analysis of Impacts A. Introduction We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601–612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104–4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule would only affect one entity that is not classified as small, we propose to certify that the proposed rule would not have a significant economic impact on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing ‘‘any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.’’ The current threshold after adjustment for inflation is $144 million, using the most current (2014) Implicit Price Deflator for the Gross Domestic PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 24413 Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount. B. Summary of Costs and Benefits FDA is proposing to ban ESDs for the purpose of treating self-injurious or aggressive behavior. Non-quantified benefits of the proposed rule include a reduction in adverse events, such as the risk of burns, PTSD, and other physical or psychological harms related to use of the device in this patient population. We expect that the proposed rule would only affect one entity that currently uses these devices to treat residents of their facility. The proposed rule would impose costs on this entity to read and understand the rule, as well as to provide affected individuals with alternative treatments. Although uncertain, other treatments or care at other facilities may cost more. To account for this uncertainty, we use a range of potential alternative treatment costs. At the lower bound, we assume that alternative treatments would cost the same as the current treatment. We use reimbursement data from the State of Massachusetts to estimate a potential upper bound for alternative treatments. The costs for the one affected entity to read and understand the rule range from $438 to $753. The present value of the incremental treatment costs over 10 years ranges from $0 to $60.1 million at a 3 percent discount rate, and from $0 to $51.4 million at a 7 percent discount rate. Annualized costs range from $0 million to $6.8 million at a 3 percent discount rate and from $0 million to $6.8 million at a 7 percent discount rate. The lower-bound cost estimates only include administrative costs to read and understand the rule with no incremental costs for alternative treatments. Additionally, there would be transfer payments between $11.5 million and $15 million annually either within the affected entity to treat the same individuals using alternative treatments, or between entities if affected individuals transfer to alternate facilities for treatment. The proposed rule’s costs and benefits are summarized in table 2, ‘‘Economic Data: Costs and Benefits Statement.’’ We also examined the economic implications of the rule as required by the Regulatory Flexibility Act. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed rule would only affect one entity that is not classified as small, we propose to certify that the proposed rule would not have a significant economic E:\FR\FM\25APP4.SGM 25APP4 24414 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules impact on a substantial number of small entities. The full discussion of economic impacts is available in Docket No. FDA– 2016–N–1111 at http://www.fda.gov/ AboutFDA/ReportsManualsForms/ Reports/EconomicAnalyses/default.htm. TABLE 2—ECONOMIC DATA: COSTS AND BENEFITS STATEMENT Units Category Benefits: Annualized. Monetized $millions/year. Annualized Quantified. Qualitative ...................... Costs: Annualized ...................... Monetized $millions/year Annualized. Quantified. Qualitative ...................... Low estimate (million) Primary estimate (million) High estimate (million) Discount rate (%) Period covered (years) Notes Year dollars ........................ ........................ ........................ ........................ ........................ ........................ Reduction in physical and psychological adverse events related to use of the device. $0 0 $3.4 3.4 $6.8 6.8 2015 2015 7 3 10 10 ........................ ........................ ........................ ........................ ........................ ........................ 7 3 10 10 Transition costs to the affected entity and individuals for transitioning to alternative treatments. Transfers: Federal. Annualized. Monetized $millions/year From: Other Annualized ........... Monetized $millions/year To: 11.5 11.5 13.3 13.3 $5 15 From: Affected entity for current treatment Effects .................................... asabaliauskas on DSK3SPTVN1PROD with PROPOSALS To: Affected entity for other treatments or to other facilities that treat aggressive or self-injurious behavior State, Local or Tribal Government: State expenditures may rise or fall if individuals move across state boundaries. Small Business: No effect. Wages: No effect. Growth: No effect. IX. Paperwork Reduction Act FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. X. Federalism FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires Agencies to ‘‘construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.’’ Federal law includes an express preemption provision that preempts certain state requirements ‘‘different from or in addition to’’ certain Federal requirements applicable to devices. (See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr, 518 U.S. 470 VerDate Sep<11>2014 2015 2015 20:57 Apr 22, 2016 Jkt 238001 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)). If this proposed rule is made final, it would create a Federal requirement under 21 U.S.C. 360k that bans ESDs for AB and SIB. XI. References The following references are on display in the Division of Dockets Management (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at http:// www.regulations.gov. FDA has verified the Web site addresses, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Cooper, S.A., E. Smiley, L.M. Allan, et al., ‘‘Adults With Intellectual Disabilities: Prevalence, Incidence and Remission of Self-Injurious Behaviour, and Related Factors.’’ Journal of Intellectual Disability Research, 53(3):200–216, 2009. 2. Ross-Collins, M.S. and K. Cornish, ‘‘A Survey of the Prevalence of Stereotypy, Self-Injury and Aggression in Children and Young Adults with Cri du Chat PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 Syndrome.’’ Journal of Intellectual Disability Research, 46(2):133–140, 2002. 3. FDA, Executive Summary. Meeting Materials of the Neurological Devices Panel 2014. Available at: http:// www.fda.gov/downloads/ AdvisoryCommittees/ CommitteesMeetingMaterials/ MedicalDevices/ MedicalDevicesAdvisoryCommittee/ NeurologicalDevicesPanel/ UCM394256.pdf. 4. Mayes, S.D., S.L. Calhoun, R. Aggarwal, et al., ‘‘Explosive, Oppositional, and Aggressive Behavior in Children With Autism Compared to Other Clinical Disorders and Typical Children.’’ Research in Autism Spectrum Disorders, 6(1):1–10, 2012. 5. Hastings, R.P., ‘‘Do Challenging Behaviors Affect Staff Psychological Well-Being? Issues of Causality and Mechanism.’’ American Journal on Mental Retardation, 107(6):455–467, 2002. 6. Emerson, E., Challenging Behavior, Analysis and Intervention in People With Severe Intellectual Disabilities. 2d ed. New York, NY: Cambridge University Press, 2001. 7. Griffin, J.C., R.W. Ricketts, D.E. Williams, et al., ‘‘A Community Survey of SelfInjurious Behavior Among Developmentally Disabled Children and E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules Adolescents.’’ Hospital and Community Psychiatry, 38(9):959–963, 1987. 8. Smith, T., solicited opinion, to FDA. Received June 30, 2015. 9. MacLean, W.E., Jr., R.C. Tervo, J. Hoch, et al., ‘‘Self-Injury Among a Community Cohort of Young Children at Risk for Intellectual and Developmental Disabilities.’’ The Journal of Pediatrics, 157(6):979–983, 2010. 10. Fish, R.M. and L.A. Geddes, ‘‘Conduction of Electrical Current to and Through the Human Body: A Review.’’ Open Access Journal of Plastic Surgery, 9:407–421, 2009. 11. Butterfield, W.H., ‘‘Electric Shock— Hazards in Aversive Shock Conditioning of Humans.’’ Behavioral Engineering, 3(1):1–28, 1975. 12. Ekman, G., M. Frankenhaeuser, S. Levander, et al., ‘‘The Influence of Intensity and Duration of Electrical Stimulation on Subjective Variables.’’ Scandinavian Journal of Psychology, 7:58–64, 1966. 13. Mason, J.L. and N.A.M. MacKay, Pain Sensations Associated With Electrocutaneous Stimulation. 1976. 14. Newman, A.L., ‘‘Self-Injurious Behavior Inhibiting System.’’ Johns Hopkins APL Technical Digest, 5(3):290–295, 1984. 15. Tursky, B., ‘‘Factors That Can Affect the Use of Electric Shock in Behavior Therapy.’’ Behavioral Engineering, 2(3):61–67, 1975. 16. Verhoeven, K. and J.G. van Dijk, ‘‘Decreasing Pain in Electrical Nerve Stimulation.’’ Clinical Neurophysiology, 117(5):972–978, 2006. 17. Blumenthal, T.D., T.T. Burnett, and C.D. Swerdlow, ‘‘Prepulses Reduce the Pain of Cutaneous Electrical Shocks.’’ Psychosomatic Medicine, 63:275–281, 2001. 18. Duker, P.C., J. van den Bercken, and M.A. Foekens, ‘‘Focusing Versus Distraction and the Response to Clinical Electric Shocks.’’ Journal of Behavior Therapy and Experimental Psychiatry, 30:199–204, 1999. 19. Tursky, B., ‘‘Physical, Physiological, and Psychological Factors That Affect Pain Reaction to Electric Shock.’’ Psychophysiology, 11(2):95–112, 1973. 20. Nave, B.C. and C.R. Nave, ‘‘Electrical Safety in the Hospital,’’ in Physics for the Health Sciences, 3d ed. Philadelphia, PA: W.B. Saunders Publishing Co., 1985. 21. JRC, Inc., public docket comment, FDA– 2014–N–0238 (P0065). Received Apr. 14, 2014. 22. Arntz, A. and P. De Jong, ‘‘Anxiety, Attention and Pain.’’ Journal of Psychosomatic Research, 37(4):423–432, 1993. 23. Delitto, A., M.J. Strube, A.D. Shulman, et al., ‘‘A Study of Discomfort With Electrical Stimulation.’’ Physical Therapy, 72(6):410–421, 1992. 24. Jones, B., M. Planas, and T. Anuza, ‘‘Painfulness Decreases the Discriminability of Electric Shock.’’ Perception & Psychophysics, 32(2):187– 191, 1982. 25. Rollman, G.B. and G. Harris, ‘‘The Detectability, Discriminability, and VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 Perceived Magnitude of Painful Electrical Shock.’’ Perception & Psychophysics, 42(3):257–268, 1987. 25a. FDA, ‘‘Medical Devices; Establishment of Procedures to Make a Device a Banned Device.’’ Federal Register, 44(98): 29214–29224, May 18, 1979. 26. FDA, Meeting Materials of the Neurological Devices Panel 2014. Available at: http://www.fda.gov/ AdvisoryCommittees/ CommitteesMeetingMaterials/ MedicalDevices/ MedicalDevicesAdvisoryCommittee/ NeurologicalDevicesPanel/ ucm394252.htm. 27. FDA, Roster. Meeting Materials of the Neurological Devices Panel 2014. Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/ MedicalDevices/ MedicalDevicesAdvisoryCommittee/ NeurologicalDevicesPanel/ UCM394254.pdf. 28. FDA, FDA Presentation: Aversive Conditioning. Meeting Materials of the Neurological Devices Panel 2014. Available at: http://www.fda.gov/ downloads/AdvisoryCommittees/ CommitteesMeetingMaterials/ MedicalDevices/ MedicalDevicesAdvisoryCommittee/ NeurologicalDevicesPanel/ UCM395135.pdf. 29. Duker, P.C. and D.M. Seys, ‘‘A QuasiExperimental Study on the Effect of Electrical Aversion Treatment on Imposed Mechanical Restraint for Severe Self-Injurious Behavior.’’ Research in Developmental Disabilities, 21:235–242, 2000. 30. Israel, M.L., N.A. Blenkush, R.E. von Heyn, et al., ‘‘Treatment of Aggression With Behavioral Programming That Includes Supplementary Contingent Skin-Shock.’’ JOBA–OVTP, 1(4), 2008. 31. Rosen, G.M. and S.O. Lilienfeld, ‘‘Posttraumatic Stress Disorder: An Empirical Evaluation of Core Assumptions.’’ Clinical Psychology Review, 28(5):837–868, 2008. 32. Scott, M.J. and S.G. 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Willis, ‘‘The Efficacy of Positive Behavioural Support E:\FR\FM\25APP4.SGM 25APP4 asabaliauskas on DSK3SPTVN1PROD with PROPOSALS Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Proposed Rules With the Most Challenging Behaviour: The Evidence and Its Implications.’’ Journal of Intellectual & Developmental Disability, 37(3):185–195, 2012. 98. JRC, Inc., JRC Publications (accessed August 7, 2015). JRC, Inc. Available at: http://judgerc.org/school/jrcpublications. 99. Carr, E.G., R.H. Horner, A.P. Turnbull, et al., Positive Behavior Support for People With Developmental Disabilities: A Research Synthesis. 1999. 100. Gedye, A., ‘‘Anatomy of Self-Injurious, Stereotypic, and Aggressive Movements: Evidence for Involuntary Explanation.’’ Journal of Clinical Psychology, 48(6):766–778, 1992. 101. McClean, B. and I. Grey, ‘‘A Component Analysis of Positive Behaviour Support Plans.’’ Journal of Intellectual & Developmental Disability, 37(3):221–231, 2012. 102. 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Dunlap, G., E.G. Carr, R.H. Horner, et al., ‘‘Positive Behavior Support and Applied Behavior Analysis: A Familial Alliance.’’ Behavior Modification, 32(5):682–698, 2008. 107. Brown, F., solicited opinion, to FDA. Received October 9, 2015. 108. Palmes, T. and P. Millington, ‘‘Positive Behaviour Support for a Child With Severe Learning Disability.’’ Learning Disability Practice, 15(10):24–27, 2012. 109. Kurtz, P.F., E.W. Boelter, D.P. Jarmolowicz, et al., ‘‘An Analysis of Functional Communication Training as an Empirically Supported Treatment for Problem Behavior Displayed by Individuals With Intellectual Disabilities.’’ Research in Developmental Disabilities, 32(6):2935–2942, 2011. 110. American Psychiatric Association, Practice Guideline for the Treatment of Patients With Borderline Personality Disorder, ed. J.M. Oldham, et al., 2001. 111. Swenson, C.R., C. Sanderson, R.A. 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LoVullo, ‘‘A Review of Behavioral Treatments for Self-Injurious Behaviors of Persons With Autism Spectrum Disorders.’’ Behavior Modification, 32(1):61–76, 2008. 124. Kahng, S. and B.A. Iwata, ‘‘Behavioral Treatment of Self-Injury, 1964 to 2000.’’ American Journal on Mental Retardation, 107(3):212–221, 2002. 125. Gonnerman, J., The School of Shock. Mother Jones, August 20, 2007. Available at: http://www.motherjones.com/politics/ 2007/08/school-shock. 126. Gonnerman, J., Experts on Self-Injurious Kids Challenge Dr. Israel’s Methods. Mother Jones, August 20, 2007. Available at: http://www.motherjones.com/politics/ 2007/08/experts-self-injurious-kidschallenge-dr-israels-methods. 127. Brown, L., public docket comment, FDA–2014–N–0238 (P0059). Received April 14, 2014. 128. McClean, B., I. Grey, and M. 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Amend § 882.5235 by revising paragraph (b) to read as follows: ■ 21 CFR Part 895 Administrative practice and procedure, Labeling, Medical devices. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, we propose that 21 CFR parts 882 and 895 be amended as follows: PART 882—NEUROLOGICAL DEVICES 1. The authority citation for 21 CFR part 882 continues to read as follows: asabaliauskas on DSK3SPTVN1PROD with PROPOSALS ■ VerDate Sep<11>2014 20:57 Apr 22, 2016 Jkt 238001 § 882.5235 Aversive conditioning device. * * * * * (b) Classification. Banned when used to reduce or cease aggressive or selfinjurious behavior. See § 895.105. Otherwise, Class II (performance standards). 4. Add § 895.105 in Subpart B to read as follows: ■ § 895.105 Electrical stimulation devices to treat aggressive or self-injurious behavior. Electrical stimulation devices to treat aggressive or self-injurious behavior are devices that apply a noxious electrical stimulus to a person’s skin to reduce or cease aggressive or self-injurious behavior. PART 895—BANNED DEVICES Dated: April 19, 2016. Leslie Kux, Associate Commissioner for Policy. 3. The authority citation for 21 CFR part 895 continues to read as follows: [FR Doc. 2016–09433 Filed 4–22–16; 8:45 am] ■ BILLING CODE 4164–01–P Authority: 21 U.S.C. 352, 360f, 360h, 360i, 371. PO 00000 Frm 00034 Fmt 4701 Sfmt 9990 E:\FR\FM\25APP4.SGM 25APP4

Agencies

[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)]
[Proposed Rules]
[Pages 24385-24418]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09433]



[[Page 24385]]

Vol. 81

Monday,

No. 79

April 25, 2016

Part VI





Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Parts 882 and 895





Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To 
Treat Self-Injurious or Aggressive Behavior; Proposed Rule

Federal Register / Vol. 81 , No. 79 / Monday, April 25, 2016 / 
Proposed Rules

[[Page 24386]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 882 and 895

[Docket No. FDA-2016-N-1111]


Banned Devices; Proposal To Ban Electrical Stimulation Devices 
Used To Treat Self-Injurious or Aggressive Behavior

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to 
ban electrical stimulation devices used to treat aggressive or self-
injurious behavior. FDA has determined that these devices present an 
unreasonable and substantial risk of illness or injury that cannot be 
corrected or eliminated by labeling. FDA is proposing to include in 
this ban both new devices and devices already in distribution and use.

DATES: Submit either electronic or written comments on the proposed 
rule by May 25, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2016-N-1111 for ``Proposal to Ban Electrical Stimulation Devices 
Used To Treat Self-Injurious or Aggressive Behavior.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
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FOR FURTHER INFORMATION CONTACT: Rebecca Nipper, Center for Devices and 
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Ave., Bldg. 66, Rm. 1540, Silver Spring, MD 20993-0002, 301-796-6527.

SUPPLEMENTARY INFORMATION:

Executive Summary

Purpose of the Proposed Rule

    FDA is proposing to ban electrical stimulation devices (ESDs) used 
for self-injurious or aggressive behavior. ESDs are devices that apply 
a noxious electrical stimulus to a person's skin upon the occurrence of 
a target behavior in an attempt to condition the individual over time 
to reduce or cease the behavior. Self-injurious behaviors (SIB) and 
aggressive behaviors (AB) frequently manifest in the same individual, 
and people with intellectual or developmental disabilities exhibit 
these behaviors at disproportionately high rates. Notably, many such 
people have difficulty communicating and cannot make their own 
treatment decisions because of such disabilities, meaning many people 
who exhibit SIB or AB are among a vulnerable population. SIB commonly 
include: Head-banging, hand-biting, excessive scratching, and picking 
of the skin. However, SIB can be more extreme and result in bleeding, 
protruding, and broken bones; blindness from eye-gouging or poking; 
other permanent tissue damage; or injuries from swallowing dangerous 
objects or substances. AB involve repeated physical assaults and can be 
a danger to the individual, others, or property. In our proposed rule, 
like much of the scientific literature, we discuss SIB and AB in 
tandem.
    ESDs are intended to reduce SIB and AB according to the principle 
of aversive conditioning. Aversive conditioning pairs a noxious 
stimulus with a target behavior such that the individual begins to 
associate the noxious stimulus with the behavior, with the intended 
result being that the individual ceases engaging in the behavior and, 
over time, becomes conditioned not to manifest the target behavior. A 
noxious stimulus is one that is uncomfortable or painful; the noxious 
stimulus delivered by an ESD is an

[[Page 24387]]

electric shock to the skin. Some ESDs are intended for other purposes, 
such as smoking cessation; however, the proposed ban includes only 
those devices intended to reduce or eliminate SIB or AB. ESDs are not 
used in electroconvulsive therapy, sometimes called electroshock 
therapy or ECT, which is unrelated to this proposed rulemaking.
    The effects of the shock are both psychological (including 
suffering) and physical (including pain), each having a complex 
relationship with the electrical parameters of the shock. As a result, 
the subjective experience of the person receiving the shock can be 
difficult to predict. Physical reactions roughly correlate with the 
peak current of the shock delivered by the ESD. However, various other 
factors such as sweat, electrode placement, recent history of shocks, 
and body chemistry can physically affect the sensation. As a result, 
the intensity or pain of a particular set of shock parameters can vary 
greatly from patient to patient and from shock to shock. Possible 
adverse psychological reactions are even more loosely correlated with 
shock intensity in that the shock need not exceed certain physical 
thresholds. Rather, the shock need only be subjectively stressful 
enough to cause trauma or suffering. Trauma becomes more likely, for 
example, when the recipient does not have control over the shock or has 
developed a fear of future shocks, neither of which is an electrical 
parameter of the shock.
    Whenever FDA finds, on the basis of all available data and 
information, that a device presents substantial deception or an 
unreasonable and substantial risk of illness or injury, and that such 
deception or risk cannot be, or has not been, corrected or eliminated 
by labeling or by a change in labeling, FDA may initiate a proceeding 
to ban the device. In making such a finding, FDA weighs the benefits 
against the risks posed by the device and considers the risks relative 
to the state of the art. With respect to ESDs for SIB and AB, FDA has 
weighed these factors based on consideration of information from a 
variety of sources, including the scientific literature, opinions from 
experts (including an advisory panel meeting), information from and 
actions of State agencies, information from the affected manufacturer, 
information from patients and their family members, and information 
from other stakeholders.
    FDA has determined that ESDs for SIB or AB present a number of 
psychological and physical risks: Depression, fear, escape and 
avoidance behaviors, panic, aggression, substitution of other behaviors 
(e.g., freezing and catatonic sit-down), worsening of underlying 
symptoms (e.g., increased frequency or bursts of self-injury), pain, 
burns, tissue damage, and errant shocks from device misapplication or 
failure. Based on literature for implantable cardioverter 
defibrillators, FDA has determined that ESDs present the risks of 
posttraumatic stress or acute stress disorders, shock stress reaction, 
and learned helplessness. That literature provides additional support 
for the risks of depression, anxiety, fear, and pain. Experts in the 
field of behavioral science, State agencies that regulate the use of 
ESDs, the sole current manufacturer and user of ESDs, and individuals 
who were subject to ESDs corroborate most of these findings, and they 
attest to additional risks.
    Our search of the scientific literature revealed a number of 
studies showing that ESDs result in the immediate interruption of the 
target behavior upon shock, and some of the literature also suggested 
varying degrees of durable conditioning. However, the studies in the 
literature suffer from serious limitations, including weak study 
design, small size, and adherence to outdated standards for study 
conduct and reporting. The conclusions of several of the studies are 
undermined by study-specific methodological limitations, lack of peer 
review, and author conflicts of interest. There is also evidence that 
the shocks are completely ineffectual for certain individuals.
    FDA weighed the benefits against the risks. FDA recognizes that 
ESDs can cause the immediate interruption of self-injurious or 
aggressive behavior, but the evidence is otherwise inconclusive and 
does not establish that ESDs improve the underlying disability or 
successfully condition individuals to achieve durable long-term 
reduction of SIB or AB. The short-term effect of behavior interruption 
is outweighed by the numerous short- and long-term risks. For many 
individuals who exhibit SIB or AB, these risks are magnified by their 
inability to adequately communicate the harms they experience to their 
health care providers. Even if immediate cessation is achieved, without 
durable conditioning the target behavior will recur over time and 
necessitate ongoing shocks to cause immediate cessation, magnifying the 
risks. For some patients, the shocks are wholly ineffective and can 
lead to progressively stronger shocks with the same result. Thus the 
degree to which the risks outweigh the benefits increases over time.
    When considering the reasonableness of the risk of illness or 
injury posed by a device in a banning proceeding, FDA also considers 
the state of the art. Notably, the use of aversive conditioning in 
general, and ESDs in particular, has been on the decline for decades; 
only one facility in the United States still uses ESDs for SIB and AB. 
This decline is due in part to scientific advances that have yielded 
new insights into the organic causes and external (environmental or 
social) triggers of SIB and AB, allowing the field to move beyond 
intrusive punishment techniques such as aversive conditioning with 
ESDs. Moreover, punishment techniques (which include the use of ESDs) 
are highly context-sensitive, so the same technique may lose 
effectiveness simply by changing rooms or providers. The evolution of 
the state of the art responded to this limitation by emphasizing skills 
acquisition and individual choice. The evolution is also due in part to 
the ethical concerns tied to the risks posed by devices such as ESDs, 
especially regarding the application of pain to a vulnerable patient 
population.
    In light of scientific advances, out of concern for ethical 
treatment, and in an attempt to create generalizable interventions that 
work in community settings, behavioral scientists have developed safer, 
successful treatments. The development of the functional behavioral 
assessment, a formalized tool to analyze and determine triggering 
conditions, has allowed providers to formulate and implement plans 
based on positive techniques. As a result, multi-element positive 
interventions (e.g., paradigms such as positive behavior support or 
dialectical behavioral therapy) have become state-of-the-art treatments 
for SIB and AB. Such interventions achieve success through 
environmental modification and an emphasis on teaching appropriate 
skills. Behavioral intervention providers may also recommend 
pharmacotherapy (the use of medications) as an adjunct or supplemental 
method of treatment. Positive-only approaches are generally successful 
even for challenging SIB and AB, in both clinical and community 
settings. The scientific community has long since recognized that 
addressing the underlying causes of SIB or AB, rather than suppressing 
it with painful shocks, not only avoids the risks posed by ESDs, but 
can achieve durable, long-term benefits.
    Based on all available data and information, FDA has determined 
that the risk of illness or injury posed by ESDs for SIB and AB is 
substantial and

[[Page 24388]]

unreasonable and that labeling or a change in labeling cannot correct 
or eliminate the unreasonable and substantial risk of illness or 
injury. The purpose of this proposed rule is to seek comments on these 
determinations as well as seek comments on FDA's proposal to ban ESDs 
used for SIB or AB and comments on any other associated issues.

Legal Authority

    The FD&C Act authorizes FDA to ban a device intended for human use 
by regulation if it finds, on the basis of all available data and 
information, that such a device presents substantial deception or an 
unreasonable and substantial risk of illness or injury. A banned device 
is adulterated except to the extent it is being studied pursuant to an 
investigational device exemption. This proposed rule is also issued 
under the authority to issue regulations for the efficient enforcement 
of the FD&C Act.
    In determining whether a deception or risk of illness or injury is 
``substantial,'' FDA will consider whether the risk posed by the 
continued marketing of the device, or continued marketing of the device 
as presently labeled, is important, material, or significant in 
relation to the benefit to the public health from its continued 
marketing. Although FDA's device banning regulations do not define 
``unreasonable risk,'' FDA previously explained that, with respect to 
``unreasonable risk,'' we will conduct a careful analysis of risks 
associated with the use of the device relative to the state of the art 
and the potential hazard to patients and users. The state of the art 
with respect to this proposed rule is the state of current technical 
and scientific knowledge and medical practice with regard to the 
treatment of patients exhibiting self-injurious and aggressive 
behavior.
    Thus, in determining whether a device presents an ``unreasonable 
and substantial risk of illness or injury,'' FDA analyzes the risks and 
the benefits the device poses to individuals, comparing those risks and 
benefits to the risks and benefits posed by alternative treatments 
being used in current medical practice. Actual proof of illness or 
injury is not required; FDA need only find that a device presents the 
requisite degree of risk on the basis of all available data and 
information.
    Whenever FDA finds, on the basis of all available data and 
information, that the device presents substantial deception or an 
unreasonable and substantial risk of illness or injury, and that such 
deception or risk cannot be, or has not been, corrected or eliminated 
by labeling or by a change in labeling, FDA may initiate a proceeding 
to ban the device.

Summary of the Major Provisions of the Proposed Rule

    If this proposed rule is finalized as proposed, the ban would 
include devices that apply a noxious electrical stimulus to a person's 
skin to reduce or cease aggressive or self-injurious behavior. The 
proposed ban would apply to devices already in commercial distribution 
and devices already sold to the ultimate user, as well as devices sold 
or commercially distributed in the future. A banned device is an 
adulterated device, subject to enforcement action. The ban may not, 
however, prevent further study of such devices pursuant to an 
investigational device exemption.

Costs and Benefits of the Proposed Rule

    FDA is proposing to ban ESDs for the purpose of treating self-
injurious or aggressive behavior. Because we lack sufficient 
information to quantify the benefits, we include a qualitative 
description of some potential benefits of the proposed rule. We expect 
that the rule would directly affect only one entity. In addition to the 
incremental costs this entity would incur to comply with the 
requirements of the proposed rule, there would be potential transfer 
payments of between $11.5 million and $15 million annually either 
within the affected entity or between entities. The present value of 
total costs over 10 years ranges from $0 million to $60.1 million at a 
3 percent discount rate, and ranges from $0 million to $51.4 million at 
a 7 percent discount rate. Annualized costs range from $0 million to 
$6.8 million at a 3 percent discount rate and range from $0 million to 
$6.8 million at a 7 percent discount rate.

                   Table of Abbreviations and Acronyms
------------------------------------------------------------------------
      Abbreviation or acronym                   What it means
------------------------------------------------------------------------
AB................................  Aggressive Behavior.
ABA...............................  Applied Behavior Analysis.
AE................................  Adverse Event.
DBT...............................  Dialectical Behavioral Therapy.
DDS...............................  (Massachusetts) Department of
                                     Developmental Services.
DEEC..............................  (Massachusetts) Department of Early
                                     Education and Care.
EA................................  Environmental Assessment.
ESD...............................  Electrical Stimulation Device.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
FONSI.............................  Finding of No Significant Impact.
GED...............................  Graduated Electronic Decelerator.
ICD...............................  Implantable Cardioverter
                                     Defibrillator.
JRC...............................  Judge Rotenberg Educational Center,
                                     Inc.
NASDDDS...........................  National Association of State
                                     Directors of Developmental
                                     Disability Services.
NYSED.............................  New York State Education Department.
PBS...............................  Positive Behavioral Support.
PTSD..............................  Post-traumatic Stress Disorder.
SIB...............................  Self-Injurious Behavior.
SIBIS.............................  Self-Injurious Behavior Inhibiting
                                     System.
------------------------------------------------------------------------

Table of Contents

I. Background
    A. Introduction
    B. What are SIB and AB, and how do they affect patients?
    C. What are ESDs and how do they affect SIB and AB?
    D. How has FDA regulated ESDs in the past?
    E. Scope of the Ban
    F. Legal Authority
II. Evaluation of Data and Information Regarding ESDs
    A. Risks of Illness or Injury Posed by ESDs
    B. Effect on Targeted Behavior
    C. State of the Art

[[Page 24389]]

III. Determination That ESDs for SIB and AB Present an Unreasonable 
and Substantial Risk of Illness or Injury
IV. Labeling
V. Application of Ban to Devices in Distribution and Use
VI. Proposed Effective Date
VII. Analysis of Environmental Impact
VIII. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
IX. Paperwork Reduction Act
X. Federalism
XI. References

I. Background

A. Introduction

    Electrical stimulation devices (ESDs) for self-injurious behavior 
(SIB) or aggressive behavior (AB) are devices that apply a noxious 
electrical stimulus (a shock) to a person's skin to reduce or cease 
such behaviors. Although FDA cleared a few of these devices more than 
20 years ago, due to scientific advances and ethical concerns tied to 
the risks of ESDs, state-of-the-art medical practice has evolved away 
from their use and toward various positive behavioral treatments, 
sometimes combined with pharmacological treatments. Only one facility 
in the United States has manufactured these devices or used them on 
individuals in recent years. As a result of this evolution in treatment 
over the past several decades, the available data and information on 
the risks and benefits of ESDs are limited.
    Although the available data and information show that some 
individuals subject to ESDs exhibit an immediate reduction or cessation 
of the targeted behavior, the available evidence has not established a 
durable long-term conditioning effect or an overall-favorable benefit-
risk profile for ESDs for SIB and AB. No randomized, controlled 
clinical trials have been conducted, and the studies that have been 
conducted are generally small and suffer from various limitations, 
including the use of concomitant treatments over long periods that make 
it difficult to determine the cause of any behavioral changes. The 
medical literature shows that ESDs present risks of a number of 
psychological harms including depression, posttraumatic stress disorder 
(PTSD), anxiety, fear, panic, substitution of other negative behaviors, 
worsening of underlying symptoms, and learned helplessness (becoming 
unable or unwilling to respond in any way to the ESD); and the devices 
present the physical risks of pain, skin burns, and tissue damage.
    Because the medical literature likely underreports adverse events 
(AEs), risks identified through other sources, such as from experts in 
the field, State agencies that regulate ESD use, and records from the 
only firm that has recently manufactured and is currently using ESDs 
for SIB and AB demand closer consideration. As discussed in section 
II.A, these sources further support the risks reported in the 
literature and indicate that ESDs have been associated with additional 
risks such as suicidality, chronic stress, acute stress disorder, 
neuropathy, withdrawal, nightmares, flashbacks of panic and rage, 
hypervigilance, insensitivity to fatigue or pain, changes in sleep 
patterns, loss of interest, difficulty concentrating, and injuries from 
falling. In contrast to the state of the art for the treatment of SIB 
and AB, the risks of ESDs are unreasonable.
    As discussed later in this document, FDA has determined that ESDs 
present a substantial and unreasonable risk of illness or injury and 
that the risks cannot be corrected or eliminated by labeling. Thus, FDA 
has decided to ban these devices under section 516 of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360f). The proposed 
rule applies to devices already in distribution and use, as well as to 
future sales of these devices.

B. What are SIB and AB, and how do they affect patients?

    SIB and AB are among the most striking and devastating conditions 
associated with intellectual and developmental disabilities (Ref. 1). 
Individuals with such disabilities may exhibit destructive behavior 
that falls within two major categories, self-injury and aggression 
toward others or property. The most common forms of self-injury include 
head-banging, hand-biting, excessive scratching, and picking of the 
skin. The most extreme cases of persons with serious self-injurious 
behavior afflict an estimated 25,000 or more individuals in the United 
States (Ref. 2). These more extreme behaviors usually involve repeated, 
self-inflicted, non-accidental injuries producing, for example: (1) 
Bleeding, protruding, and broken bones; (2) eye gouging or poking 
leading to blindness; (3) other permanent tissue damage; and (4) 
swallowing dangerous substances or objects. (For a more detailed 
technical discussion, see Ref. 3.)
    Persons who exhibit SIB also frequently demonstrate aggression, the 
other major category of destructive behavior. Aggressive behaviors 
encompass a wide range of behaviors, which are generally defined by 
conduct that, due to its intensity or frequency, presents an imminent 
danger to the person who demonstrates it, to other people, or to 
property (see, e.g., Ref. 4 for a discussion of aggression in autistic 
children). Aggressive behaviors that involve repeated physical assaults 
are dangerous particularly for caregivers and family. Beyond the 
potential for obvious physical injury, SIB and AB can be very 
distressing for parents and caregivers (Ref. 5), severely limit the 
patient's participation in community activities, and lead to placement 
of the patient in a more restrictive living environment (Ref. 6). 
Accordingly, intervention is necessary for the safety of the individual 
engaging in the aggressive behavior, for those against whom the 
aggression is directed, and for the protection of property.
    The majority of published studies on SIB include aggression either 
as part of the description of the clinical spectrum of the behavior or 
as an inclusion criterion for the clinical study. Accordingly, this 
proposed rule addresses self-injury and aggression in tandem as SIB and 
AB. Destructive behavior in both major categories--aggression and self-
injury--are often present in individuals with intellectual or 
developmental disabilities. Examples of those disabilities include, but 
are not limited to: Autism spectrum disorder, Cornelia de Lange 
syndrome, Down syndrome, Fragile X syndrome, hereditary sensory 
neuropathy, Lesch-Nyhan syndrome, Rett syndrome, and Tourette syndrome. 
Those disabilities may also include visual impairment, severe 
intellectual impairment, and a variety of cognitive and psychiatric 
disorders.
    Estimates of the prevalence of SIB in individuals with intellectual 
or developmental disabilities range from 2.6 percent to 40 percent 
(Ref. 7), or 2 to 23 percent in community samples (Ref. 8). More 
recently, one analysis found a prevalence of SIB in a clinical 
population of children with developmental disabilities at 32 percent, 
suggesting that the actual prevalence may be at the high end of earlier 
estimates (Ref. 9). Estimates of the prevalence of AB in individuals 
with intellectual or developmental disabilities range as high as 52 
percent, though 10 percent is more commonly reported (Ref. 8). Thus, by 
conservative estimates, counting only individuals who have intellectual 
or developmental disabilities (and not all people who manifest SIB or 
AB), at least 330,000 people in the United States manifest SIB, AB, or 
both; less conservative estimates are much higher (see Refs. 3 and 
8).\1\
---------------------------------------------------------------------------

    \1\ An estimated 1 to 3 percent of individuals in the United 
States have an intellectual or developmental disability (Ref. 8). 
Given a U.S. population of 330 million, at least 3.3 million people 
would have such a disability; 10 percent of 3.3 million is 330,000, 
and 2 percent of 3.3 million is 66,000. If there is no overlap, the 
total would be 396,000 people. These numbers are based on the lowest 
bounds reported in Ref. 8. Using the same source and method, the 
highest bound would yield an estimate of about 7.4 million people.

---------------------------------------------------------------------------

[[Page 24390]]

C. What are ESDs and how do they affect SIB and AB?

    As stated, ESDs apply a noxious electrical stimulus (a shock) to a 
person's skin upon the occurrence of a target behavior in an attempt to 
reduce or cease the behavior. As such, ESDs are a type of aversive 
conditioning device (``aversive''). ESDs apply shocks to the skin. ESDs 
are not used in ECT, sometimes called electroshock therapy, which is 
unrelated to this rulemaking. The electrical shock from an ESD is 
intended to interrupt the undesirable behavior and result in its quick 
cessation. Repeatedly pairing the shock with the unwanted behavior is 
intended to cause individuals to associate the two and thereby induce 
them to decrease the frequency of the behavior or stop it altogether. 
In order to achieve the intended results, the shock must be applied 
during the behavior (for cessation and decrease) or immediately 
afterward (for decrease). ESDs are intended to affect behavior in two 
ways: By interrupting the target behavior as an immediate response to 
the stimulus and, over time, through a conditioned reduction in the 
target behavior.
    The main components of ESDs are an electrical stimulus generation 
module, electrodes, and a trigger switch. Either a remote monitor 
module or an automatic mechanism can trigger the electric shock to the 
individual. Typically, the patient carries the stimulus generation 
module, which applies an electrical current (the shock) to the 
individual's skin via electrodes. When a remote monitor is used, an 
observer determines when to apply an electrical shock to the patient 
and triggers a shock from a specific stimulus generation module via a 
radiofrequency signal. Alternatively, a sensor can detect certain 
unwanted behaviors and automatically activate the generation module. 
For example, an accelerometer attached to the head could detect head-
banging and, when the behavior is severe enough, trigger an electrical 
shock.
    Although several factors specific to the patient affect shock 
perception, the key device output characteristics that most affect 
shock perception include: Electric current, voltage, skin resistance 
(or load), pulse width, shock duration, output frequency and waveform, 
electrode characteristics (e.g., size, location, design, or material), 
and the number and frequency of shocks delivered. For the purposes of 
this proposed rule, a stronger shock is one for which at least one of 
those parameters is adjusted to increase the intensity or sensation.
    Electric current, measured in milliamperes (mA) for ESDs, is the 
primary variable for determining the effects of an electric shock that 
passes through the body. To determine the current output of a device 
designed to deliver a constant voltage, the voltage is divided by the 
electric resistance, measured in ohms ([Omega]), the relationship 
described by Ohm's Law. A lower resistance for a given voltage results 
in higher current; the skin's conducting resistance can vary between 1 
k[Omega] and 100 k[Omega] (Refs. 10 and 11). Sweat and blood are 
excellent conductors and therefore lower the conducting resistance, 
which increases the current and the intensity of the stimulus.
    The sensory nerves respond to the current as a function of its 
strength and duration. A stronger current will elicit a response with a 
shorter pulse width, and a weaker current will need a longer pulse 
width to elicit the same response. The pulse width (or pulse duration) 
is the length of time a pulse of current is applied to the skin, 
measured in milliseconds for ESDs. Longer pulse durations have been 
shown to increase the intensity or unpleasantness of the sensation in 
healthy subjects (Refs. 12-14).
    The characteristics of the electrodes that deliver the shock to the 
skin also affect the perception of the shock. The amount of current 
delivered per unit area of an electrode is referred to as the current 
density. A higher current density has been found to correspond with a 
more intense or unpleasant feeling (Refs. 15 and 16). One study has 
shown that smaller electrodes deliver painful shocks that are described 
as sharp, cutting, or lacerating. Larger electrodes for the same 
current are associated with pain that was pinching, pressing, or 
gnawing (Ref. 16). A related measure, power density, is found by 
multiplying the current and the voltage and relating the product to 
surface area; it is expressed as watts per unit area. Both current and 
power densities correlate with the risk of burns; a higher current or 
power density increases the risk. The risk of burns also increases when 
the current itself is direct current; all FDA-cleared ESDs utilize 
alternating current (AC) rather than direct current (DC).
    Electrodes additionally affect pain sensation in that placement on 
locations with a higher density of sensory nerves will result in more 
pain. For that reason, the hands, feet, genitals, underarms, torso, 
neck, and face will be particularly sensitive to shocks. Repeated 
shocks to the same location will also alter the perception, increasing 
intensity or pain (Refs. 17-19). The exact mechanism behind this change 
is unclear, but one hypothesis holds that the changing sensation may 
result from changes in the skin's electrical resistance (Ref. 19). 
Others have hypothesized that repeated stimulation depletes endorphins, 
which are chemicals that affect pain sensation (Ref. 17).
    Finally, with regard to key device output parameters, some authors 
have attempted to relate physiological responses, sensations and muscle 
contraction for example, to electric current (e.g., Refs. 10, 11, and 
20). The Judge Rotenberg Educational Center, Inc. (JRC), the only 
entity of which FDA is aware that has recently manufactured ESDs and 
that currently uses ESDs, has submitted a similar comparison (Ref. 21). 
However, comparisons based solely upon the electric current 
oversimplify the relationship because they do not account for other key 
parameters, nor do they account for intersubject variability in 
perception. (See, for example, Refs. 11, 17, 18, and 22-25). Such 
comparisons also do not account for the recipient's psychological state 
(Refs. 18, 22, and 23), which can affect the response to shocks. 
Furthermore, the relationships between current and response as reported 
by these authors (Refs. 10, 11, and 20) are more relevant in a setting 
where a body part comes into direct contact with a 60-Hz AC electrical 
source (e.g., a current from a wall outlet), with the current passing 
through the chest. In contrast, ESDs provide localized stimulation to 
the skin through an electrode interface. Thus, although the amount of 
current may suggest a type of response (e.g., tingling, pain, or 
involuntary muscle contraction), predictions based on such thresholds 
are subject to considerable uncertainty.
    These key device output parameters affect the experience of the 
shock primarily in terms of physiological responses (see Ref. 3 for a 
more technical discussion). As explained in more detail in section 
II.A.1, a stimulus need not be physically intense to trigger an adverse 
psychological reaction. Thus, although lower peak current or shorter 
pulse duration corresponds with lower physical intensity, neither 
necessarily corresponds with a less-adverse psychological response. 
Table 1 summarizes the device output characteristics of ESDs for SIB or 
AB

[[Page 24391]]

that have been cleared by FDA or are currently in use. Note that FDA 
has cleared 510(k)s for ESDs for SIB or AB from other manufacturers 
besides JRC.

                                                         Table 1--Device Output Characteristics
--------------------------------------------------------------------------------------------------------------------------------------------------------
         Device name            Average current     Max current       Max voltage       Pulse width     Shock duration     Frequency      Power density
--------------------------------------------------------------------------------------------------------------------------------------------------------
Whistle Stop 1...............  ................  10 mA at 20       200 V...........  1-2 ms..........  0.5-12 s.......  10 Hz..........  0.02 W/cm. 2
                                                  k[Omega].
SIBIS........................  3.5 mA at 20      10 mA...........  200 V...........  6.2 ms..........  0.1-0.2 s......  80 Hz..........  0.16 W/cm. 2
                                k[Omega].
GED, GED-3A 2................  12 mA at 5        29.4 mA at 5      150 V...........  3.125 ms........  2 s............  80 Hz..........  1.01 W/cm. 2
                                k[Omega].         k[Omega].
GED-4 2......................  42 mA at 5        90 mA...........  ................  3.125 ms........  2 s............  80 Hz..........  ...............
                                k[Omega].
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The 510(k) did not include enough information for FDA to determine the average current of the device (as indicated by blank field).
\2\ The GED-3A and GED-4 have not been cleared or approved by FDA, and we do not have information about all device characteristics (as indicated by
  blank fields).

    Again, individual patient variability makes comparison across 
devices--and even individual shock applications--difficult. Some people 
are generally highly sensitive to current, experiencing involuntary 
muscle contraction from static electric shocks. On the other end of the 
spectrum, some individuals can draw a large static electric spark and 
hardly perceive it, much less experience a muscle spasm. Studies of 
subjects without intellectual or developmental disabilities have 
demonstrated a large range of intersubject variability for equally 
applied shocks. For example, one study found that the range of pain 
thresholds was 3.9 to 11.6 mA (Ref. 11), while another found the range 
was 0.45 to 2.4 mA (Ref. 25). Such articles often did not include key 
output characteristics, such as pulse width and frequency or electrode 
size and placement, further confounding attempts to compare or apply 
the findings. In light of variability and methodological limitations 
underlying the reported current-response relationships, physiological 
responses, including pain perception, are difficult to predict 
accurately, especially based solely on the current.

D. How has FDA regulated ESDs in the past?

    In 1979, FDA classified aversive conditioning devices as class II 
(see Sec.  882.5235 (21 CFR 882.5235)), which was consistent with the 
recommendation of the Neurological Device Classification Panel of the 
Medical Device Advisory Committee in 1978. Such devices may or may not 
use electric shocks to administer a ``noxious stimulus to a patient to 
modify undesirable behavioral characteristics'' (Sec.  882.5235). Thus, 
ESDs intended to treat SIB and AB are within the aversive conditioning 
device classification regulation. The proposed rule for classifying 
aversives, including ESDs, focused on the risks of: (1) Worsened 
psychological conditions, (2) errant electric shocks, and (3) the 
harmful or lethal nature of excess electric current or its 
inappropriate application (43 FR 55705, November 28, 1978). At the 
time, FDA and the panelists believed that performance standards could 
adequately assure the safety and effectiveness of aversives. We 
received no comments from the public on the proposed rule, and we 
issued the final rule classifying aversives as proposed at Sec.  
882.5235 (44 FR 51726 at 51765, September 4, 1979).
    FDA has cleared four devices for the treatment of SIB as 
substantially equivalent to the ones initially placed into class II, 
510(k) notification numbers and clearance dates in parentheses:
     Stimulator Sonic Control, ``Whistle Stop'' (K760166; July 
20, 1976);
     Self-Injurious Behavior Inhibiting System, ``SIBIS'' 
(K853178; February 28, 1986);
     SIBIS Remote Actuator (K871158; May 29, 1987); and
     Graduated Electronic Decelerator, ``GED'' (K911820; 
December 5, 1994).
    A prescription is required for each, meaning that Federal law 
restricts the sale of these aversives to professionals licensed 
according to State requirements or those acting pursuant to a licensed 
professionals orders (see 21 CFR 801.109).
    As part of the evaluation of the premarket notifications, i.e., the 
510(k) submissions, FDA reviewed the average current (the amount of 
electricity) and power density of the shocks (the wattage applied to a 
given area of skin), among other things. Average current and power 
density are important parameters in determining the likelihood and 
severity of a potential physical injury from a shock. The cleared ESDs 
include warnings never to place electrodes on the head or chest, or in 
such a way that current would flow through the chest because this could 
cause ventricular fibrillation (a dangerous irregularity in the 
heartbeat).
    We are aware of only one manufacturer, JRC, that has recently 
manufactured ESDs and that currently uses ESDs, including devices that 
we have not previously cleared. JRC uses these devices because it is 
also a residential facility, and its employees apply the devices to 
individuals there. In 2000, FDA incorrectly notified JRC that it 
qualified for exemption from registration and 510(k) requirements under 
21 CFR 807.65(d). Once FDA recognized its error, FDA sent JRC an 
Untitled Letter on May 23, 2011, and a Warning Letter on December 6, 
2012, for violations related to the lack of FDA clearance or approval 
for the modified GED devices.\2\
---------------------------------------------------------------------------

    \2\ The Warning Letter is available on the Internet at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm331291.htm.
---------------------------------------------------------------------------

    FDA now has a better understanding of the risks and benefits 
presented by these devices than it did 36 years ago when these devices 
were classified, and, as discussed later in sections II.A and II.B, the 
state of the art for the treatment of SIB and AB has progressed 
significantly over that time period. As a result, FDA now believes that 
the risk of illness or injury from the use of ESDs for the treatment of 
SIB and AB is unreasonable and substantial.

E. Scope of the Ban

    The ban would apply to devices that apply a noxious electrical 
stimulus to a person's skin to reduce or stop aggressive or self-
injurious behavior. (See section I.B for a discussion of the relevant 
behaviors; see also Ref. 3 for a more technical discussion of the 
scientific literature regarding these behaviors.) To FDA's knowledge, 
the only such devices that are currently in use are two models of the 
GED device (the GED-3A and GED-4), neither of which has been cleared or 
approved by the Agency.
    The ban would not apply to ESDs used to create aversions to other 
conditions or habits, such as smoking. Although other ESDs have 
parallels in

[[Page 24392]]

treatment strategy and method, those devices address very different 
conditions in very different patient populations. Smoking-cessation 
devices differ with respect to whether patients have control over the 
shocks--and what level of control they have--as well as how the 
electric shock affects the target behavior and underlying conditions. 
These differing types of ESDs thus present different benefit-risk 
profiles.
    Importantly, individuals who manifest SIB or AB typically have 
additional vulnerabilities that relate directly to the risks of the 
treatment method. For example, individuals with intellectual or 
developmental disabilities who manifest SIB or AB, and who have 
difficulty communicating pain or other harms that may be caused by ESDs 
would bear a higher risk of injury from the shock than smokers who 
choose to use an ESD to help quit smoking. Those smokers, if without 
intellectual or developmental disabilities, can immediately communicate 
pain to the device's controller or remove the device themselves. They 
can communicate symptoms of other harms that may be caused by ESDs, 
such as PTSD, to their health care provider, which may lead to 
discontinuation of the device's use. Communication challenges in 
patients who suffer from SIB and AB are discussed in the literature, 
were raised by the advisory panel, and are reviewed in more detail in 
section II.A.

F. Legal Authority

    Section 516 of the FD&C Act authorizes FDA to ban a device intended 
for human use by regulation if it finds, on the basis of all available 
data and information, that such a device ``presents substantial 
deception or an unreasonable and substantial risk of illness or 
injury'' (21 U.S.C. 360f(a)(1)). A banned device is adulterated under 
section 501(g) of the FD&C Act (21 U.S.C. 351(g)), except to the extent 
it is being studied pursuant to an investigational device exemption 
under section 520(g) of the FD&C Act (21 U.S.C. 360j(g)). This proposed 
rule is also issued under the authority of section 701(a) of the FD&C 
Act (21 U.S.C. 371(a)), which provides authority to issue regulations 
for the efficient enforcement of the FD&C Act.
    In determining whether a deception or risk of illness or injury is 
``substantial,'' FDA will consider whether the risk posed by the 
continued marketing of the device, or continued marketing of the device 
as presently labeled, is important, material, or significant in 
relation to the benefit to the public health from its continued 
marketing (see Sec.  895.21(a)(1) (21 CFR 895.21(a)(1))). Although 
FDA's device banning regulations do not define ``unreasonable risk,'' 
in the preamble to the final rule promulgating 21 CFR part 895, FDA 
explained that, with respect to ``unreasonable risk,'' it ``will 
conduct a careful analysis of risks associated with the use of the 
device relative to the state of the art and the potential hazard to 
patients and users'' (44 FR 29214 at 29215, May 18, 1979; Ref. 25a). 
The state of the art with respect to this proposed rule is the state of 
current technical and scientific knowledge and medical practice with 
regard to the treatment of patients exhibiting self-injurious and 
aggressive behavior.
    Thus, in determining whether a device presents an ``unreasonable 
and substantial risk of illness or injury,'' FDA analyzes the risks and 
the benefits the device poses to individuals, comparing those risks and 
benefits to the risks and benefits posed by alternative treatments 
being used in current medical practice. Actual proof of illness or 
injury is not required; FDA need only find that a device presents the 
requisite degree of risk on the basis of all available data and 
information (H. Rep. 94-853 at 19; 44 FR 28214 at 29215).
    Whenever FDA finds, on the basis of all available data and 
information, that the device presents substantial deception or an 
unreasonable and substantial risk of illness or injury, and that such 
deception or risk cannot be, or has not been, corrected or eliminated 
by labeling or by a change in labeling, FDA may initiate a proceeding 
to ban the device (see Sec.  895.20). If FDA determines that the risk 
can be corrected through labeling, FDA will notify the responsible 
person of the required labeling or change in labeling necessary to 
eliminate or correct such risk (see Sec.  895.25).
    Section 895.21(d) requires this proposed rule to briefly summarize:
     The Agency's findings regarding substantial deception or 
an unreasonable and substantial risk of illness or injury;
     the reasons why FDA initiated the proceeding;
     the evaluation of the data and information FDA obtained 
under provisions (other than section 516) of the FD&C Act, as well as 
information submitted by the device manufacturer, distributer, or 
importer, or any other interested party;
     the consultation with the classification panel;
     the determination that labeling, or a change in labeling, 
cannot correct or eliminate the deception or risk;
     the determination of whether, and the reasons why, the ban 
should apply to devices already in commercial distribution, sold to 
ultimate users, or both; and
     any other data and information that FDA believes are 
pertinent to the proceeding.

We have grouped some of these together within broader categories and 
addressed them in the following order:
     Evaluation of data and information regarding ESDs, 
including data and information FDA obtained under provisions other than 
section 516 of the FD&C Act, information submitted by the device 
manufacturer and other interested parties, the consultation with the 
classification panel, and other data and information that FDA believes 
are pertinent to the proceeding, with respect to risks, benefits, and 
the state of the art;
     the reasons FDA initiated the proceeding and FDA's 
determination that ESDs for SIB and AB present an unreasonable and 
substantial risk of illness or injury (FDA has not made a finding 
regarding substantial deception);
     FDA's determination that labeling, or a change in 
labeling, cannot correct or eliminate the risk; and
     FDA's determination that the ban applies to devices 
already in commercial distribution and sold to ultimate users, and the 
reasons for this determination.

II. Evaluation of Data and Information Regarding ESDs

    In considering whether to ban ESDs, FDA first conducted an 
extensive, systematic literature review to assess the benefits and 
risks associated with ESDs as well as the state of the art of treatment 
of patients exhibiting SIB and AB. In the literature review, as 
explained earlier, SIB and AB were considered in tandem, and these 
conditions presented in individuals with intellectual and developmental 
disabilities, such as autism spectrum disorder, Down syndrome, Tourette 
syndrome, as well as other cognitive or psychiatric disorders and 
severe intellectual impairment (including a broad range of intellectual 
measures). The studies encompassed both children and adults. (For more 
technical details, see Ref. 3.)
    FDA next convened a meeting of the Neurological Devices Panel of 
the Medical Devices Advisory Committee (``the Panel'') on April 24, 
2014 (``the Panel Meeting''), in an open public forum, to discuss 
issues related to FDA's consideration of a ban on ESDs for SIB and AB 
(see 79 FR 17155, March 27, 2014; Ref. 26). Although FDA is not

[[Page 24393]]

required to hold a panel meeting before banning a device, FDA decided 
to do so in the interest of gathering as much data and information as 
possible, from experts in relevant medical fields as well as all 
interested stakeholders, before proposing this significant regulatory 
action. Eighteen panelists with expertise in both pediatric and adult 
patients represented the following biomedical specialties: Psychology, 
psychiatry, neurology, neurosurgery, bioethics, and statistics, as well 
as representatives for patients, industry, and consumers (Ref. 27). FDA 
provided a presentation that described the banning standard, the 
regulatory history of aversive conditioning devices, alternative 
treatments, and a summary of the benefits and risks of ESDs, including 
a comprehensive, systematic literature review based on the information 
available at that time (Refs. 3 and 28). After the Panel Meeting, we 
reviewed all 294 comments from 281 unique commenters submitted to the 
public docket created for the Panel Meeting (Docket No. FDA-2014-N-
0238).
    FDA considered all available data and information from a wide 
variety of sources, including from the categories listed in this 
document. In weighing each piece of evidence, FDA took into account its 
quality, such as the level of scientific rigor supporting it, the 
objectivity of its source, its recency, and any limitations that might 
weaken its value. Thus, for example, we generally gave much more weight 
to the results of a study reported in a peer-reviewed journal than we 
did to non-peer-reviewed papers.
     The scientific literature. FDA considered published 
scientific sources to understand SIB and AB as well as the risks and 
benefits of ESDs and the state of the art for the treatment of 
challenging behaviors. However, several limitations influenced the 
conclusions drawn from the literature, including the likely 
underreporting of AEs, reporting biases, and various methodological 
weaknesses.
     Information and opinions from experts, including those 
expressed by the panelists at the Panel Meeting, as well as those 
expressed in individual expert reports obtained by FDA from Drs. 
Tristram Smith, Gary LaVigna, and Fredda Brown. Each of these experts 
has experience in the field of behavioral psychology, particularly with 
individuals who manifest SIB or AB. Drs. LaVigna and Brown have 
expertise regarding the state of the art for treatment of SIB and AB 
and the development of positive behavioral treatment plans for 
patients, including for transition away from ESDs and other aversive 
strategies. FDA obtained reports from these experts to supplement our 
understanding of the risks and benefits of ESDs and the state of the 
art for the treatment of SIB and AB.
     Information from State agencies and State actions on ESDs. 
FDA has considered information regarding the use of ESDs for SIB and AB 
from agencies in Massachusetts and New York. These agencies possess 
substantial information on ESDs for SIB and AB because the overwhelming 
majority of patients--nearly 75 percent--on whom ESDs are used are from 
these two States. According to information provided by JRC in its 
comments, 60 of the 82 individuals enrolled at JRC as of April 2014 on 
whom GED devices were used are from these two States. FDA also 
considered a comment from the Executive Director of the National 
Association of State Directors of Developmental Disabilities Services 
(NASDDDS), which was supportive of a ban, and various State legal 
actions related to the use of ESDs for SIB and AB.
     Information from the affected manufacturer/residential 
facility. In addition to presenting information at the Panel Meeting 
and responding to questions from Panel members, JRC has made several 
submissions to the Panel Meeting docket, as has a former JRC clinician.
     Information from patients and their family members. Three 
individuals formerly on ESDs at JRC and family members of four such 
individuals currently at JRC spoke against a ban at the Panel Meeting. 
Two associations of family members of such individuals submitted 
comments opposing a ban (one of the comments included 32 letters from 
family members). Two individuals formerly on ESDs at JRC spoke in favor 
of a ban at the Panel Meeting, and one other individual submitted a 
comment in favor of a ban. In 2013 and 2014, FDA clinicians interviewed 
three individuals formerly on ESDs at JRC by phone (one of whom spoke 
in favor of a ban at the Panel Meeting).
     Information from other stakeholders, including other 
government entities, disability rights groups, and members of the 
public. In addition to NASDDDS and a JRC parents group, referenced 
earlier, 15 other organizations concerned with the treatment and the 
rights of individuals with disabilities spoke at the Panel Meeting, all 
of which supported a ban. Twenty-two disability rights organizations 
submitted written comments to the Panel Meeting docket, one of which 
was signed by 23 disability rights groups. Nine of these organizations 
were among the 15 represented at the Panel Meeting. All of these 
comments support the ban. FDA also received a comment from the U.S. 
Department of Justice Civil Rights Division supportive of a ban, and we 
considered information from the National Council on Disability, the 
National Institutes of Health, and the United Nations Special 
Rapporteur on Torture.

A. Risks of Illness or Injury Posed by ESDs

1. Scientific Literature
    FDA conducted an extensive, systematic review of the medical 
literature for harms, i.e., AEs, associated with ESDs to understand 
specific risks and dangers that ESDs present to individuals' health. As 
previously discussed, the focus of the analysis in considering a ban is 
on risks and does not require proof of actual harm, but evidence of 
actual harms helps inform the analysis. One prospective case-control 
study and one retrospective chart review of 60 patients reported AEs 
(Refs. 29 and 30, respectively). Additionally, 26 case reports or 
series encompassing 66 subjects included an assessment of AE 
occurrences. Ten other case reports or series did not assess AEs, and 6 
articles, encompassing 11 subjects in total, noted that the researchers 
did not observe AEs in their subject population. (See table 4 in Ref. 3 
for a summary of articles reviewed for adverse events.) We identified 
the following AEs in the literature.
    a. Psychological risks. The risks of psychological harm are less 
tightly linked to the electrical parameters of an ESD shock than are 
physical risks (section I.C discussed shock parameters and how they 
relate to the physical response). For example, when the recipient does 
not have control over the shocks and has previously received multiple 
such shocks, psychological trauma such as an anxiety or panic reaction 
can result even when the strength is relatively modest (Ref. 31). In 
this example, the shock does not necessarily need to be stronger to 
increase the risk of psychological trauma; it need only recur. 
Similarly, the shock need not be painful; it need only be 
psychologically stressful.
    Further, a series of less traumatic events can cause the 
development of stress disorders such as PTSD. The underlying trauma 
need not be a single, discrete event, although a single trauma can lead 
to PTSD (Ref. 32; see also Ref.

[[Page 24394]]

31, discussing research on stressors prior to the 2013 update of the 
Diagnostics and Statistical Manual of Mental Disorders). Shocks that 
may be tolerable on their own could, in series, amount to a traumatic 
experience leading to a stress disorder. (See Ref. 33 discussing 
impaired cue-reversal independent of level of trauma.) In turn, such 
disorders can leave an individual susceptible to future traumas such as 
anxiety reactions that can be triggered by a relatively weak stimulus. 
For example, a provider reaching for an ESD remote control can trigger 
an anxiety response in individuals wearing ESDs, even without a shock. 
Thus, although a shock may need to surpass a minimum subjective 
threshold to be harmful (e.g., the shock needs to be sufficiently 
stressful to the recipient), that subjective minimum (what is 
sufficiently stressful) does not correspond with a particular objective 
minimum (shock parameters).
    Several articles reported aversion, fear, and anxiety in response 
to ESDs. One article states that ESDs may initially evoke fear, panic, 
and even aggression responses (Ref. 34). For the most part, researchers 
have interpreted these events as anticipatory responses prior to or 
upon stimulus application. In addition to reports of panic and bouts of 
aggression, others have reported events such as screaming, crying, or 
shivering upon device application; grimacing; flinching; perspiring; 
and escape behavior (Refs. 34-43). One article reported a temporary 
aversion to the experimenter (Ref. 36). Such fear, anxiety, or panic 
reactions are additionally concerning because when they cause the 
individual to sweat, they would lead to electrical conductivity changes 
across the skin that increase the intensity of the electric shock.
    Other articles report substitution of behaviors--negative or 
collateral--that span a range of severity. One author speculated that, 
in institutional settings, ``the probability that a replacement 
behavior will be undesirable is quite high'' (Ref. 44). Some patients 
``froze by refraining from showing any sort of behavior'' (Ref. 34). 
Similarly, others reported a ``pseudocatatonic sit-down,'' i.e., 
muscular freezing or melting (Ref. 45). One study described temporary 
tensing of the body and noted attempts to remove the device or grab the 
transmitter during treatment (Ref. 30). Some patients resorted to 
hostility and retaliation (Ref. 46), including surrogate retaliation, 
threats, and warnings (Ref. 45). In some patients, another undesirable 
behavior known as self-restraint, where patients attempt to physically 
restrain themselves, for example, with their clothing, emerged or 
intensified (Refs. 29 and 47). Others exhibited lesser self-injury and 
aggression, non-injurious pinching, emotional behaviors, and napkin-
tearing. (See also Refs. 30 and 43.) In some cases, crying increased 
(Ref. 48). One study reported that, as measured by rating scales of 
dependency, affection-seeking increased repeatedly during treatment 
(Ref. 42).
    Temporary or long-term increases in symptoms have also been 
attributed to ESDs in the literature. One article reported increases in 
emotionality and the frequency of self-injury, as well as post-
treatment incontinence (Ref. 49). Another observed increasing episodic 
``bursts'' of self-injury, eventually reaching the point that extended 
treatment with the ESD became impossible to maintain (Ref. 50).
    Some ESDs have been used for conditions other than SIB and AB, 
e.g., obsessions or compulsions, according to the same principle of 
aversive conditioning. FDA believes that reports of AEs from these 
alternative uses are informative regarding the risks of ESDs for SIB 
and AB because individuals with ESDs for other conditions generally do 
not have the same patient vulnerabilities that often accompany SIB and 
AB. As discussed in sections II.A.2 and A.3, these vulnerabilities 
generally increase the risk of harm from ESDs for individuals who 
manifest SIB or AB, so any harms from ESDs for other uses would be at 
least as likely, if not more so, to cause harm to many patients 
exhibiting SIB or AB.
    One article on the effects of shock on five subjects to reduce 
obsessions and compulsions reported that one subject demonstrated 
anxiety and psychotic delusions (Ref. 51). One case-control study on 
ESDs used to treat alcohol dependence in 12 subjects found that 
symptoms of experimental repression, such as headaches, restlessness, 
and mild dysphoria, were common and appeared usually within 3 or 4 days 
of the treatment (Ref. 52). Another researcher performed a prospective 
study of ESDs used for smoking cessation in 14 subjects. The author 
reported that seven subjects exhibited mild transient depression (Ref. 
53). FDA acknowledges that confounding factors potentially contributed 
to these AEs.
    Since ESDs are aversive conditioning devices, FDA also considered 
AEs associated with aversive conditioning more generally. We identified 
12 review articles examining AEs associated with punishment or aversive 
conditioning. Many of the reviews acknowledge the possibility of 
negative emotional reactions associated with punishment in general, 
such as fear or avoidance (Refs. 54-59) and anxiety and depression 
(Ref. 54). Some reviews, similar to the findings specific to ESDs, 
noted AEs that include retaliation, increased aggression, or 
substitution of one injurious behavior for another (Refs. 54 and 57-
60).
    FDA believes that the risks posed by another type of device that 
delivers a shock to the patient are instructive. Specifically, a 
comparison to implantable cardioverter defibrillator (ICD) devices 
further supports the potential for certain psychological risks in 
patients receiving shocks from ESDs for SIB and AB. While the strength 
and purposes of the shock differ significantly between ICDs and ESDs, 
the psychological risks posed by ESDs do not necessarily depend on the 
strength of the shock, as discussed earlier, and FDA does not believe 
the different purposes of the shocks undermine the comparison for the 
following reasons. Treatment with either of these devices entails 
several similar characteristics that support a comparison, including 
the lack of patient control over the shocks, the application of 
multiple shocks, and the startling or unpleasant nature of the shocks. 
We found that fear of future shocks, in particular, is a trauma that is 
shared for both the ICD and ESD populations, unlike other trauma 
experiences in which subsequent trauma (repetition of the experience) 
is unlikely, indicating that ongoing application worsens the harm (Ref. 
61).
    The following risks have been reported in the literature for ICDs: 
The development of PTSD, acute stress disorder, a shock stress reaction 
(a temporary condition), learned helplessness, depression, and anxiety 
(Refs. 61-63). A contributing factor in the development of these harms 
in patients with an ICD may be that treatment with an ICD may act as a 
constant reminder of the underlying life-threatening disease condition 
(Ref. 64). A 2011 report observed that ``[t]he available research 
literature can only provide a limited view of whether ICD shock or the 
potentially life-threatening arrhythmic condition is the primary driver 
of a PTSD presentation'' (Ref. 61). However, Sears and Conti report 
that ``[s]hock is the major distinguishing factor between patients with 
ICDs and general cardiac patient populations'' (Ref. 63), meaning that 
the presence of an ICD, rather than the underlying cardiac condition, 
increases the psychological risks. Other authors have reported that ICD 
shocks may cause distress either from the associated pain, skeletal 
muscle contraction, and nerve

[[Page 24395]]

stimulation or merely from fear of shocks (Ref. 62).
    Because of the similar characteristics of the shocks delivered by 
ICDs and ESDs, and because the identified risks may be attributable to 
the ICD shock itself, as opposed to the fear of a life-threatening 
condition, the risks of development of PTSD or a shock stress reaction, 
learned helplessness, depression, or anxiety may also exist when shocks 
are applied by ESDs in patients with SIB or AB. FDA notes that due to 
the drastically different intended uses, patient populations, benefit-
risk profiles, and state of the art for these devices, FDA is not 
considering banning ICDs.
    b. Physical risks. Research shows that shock strength and other 
device characteristics play a role in shaping the physical response to 
ESDs, such as whether the patient receives burns or experiences pain 
(see section I.C). We note that the lack of complete information 
regarding shock characteristics in much of the literature can make it 
difficult to determine to which ESDs these findings are applicable.
    The literature contains many reports of tissue damage or burns from 
ESDs. Reports of skin damage ranged from burns to bruises to slightly 
reddened or discolored areas. In all such reports, the effects were 
temporary (Refs. 29, 30, 39, 41, 50, and 65).
    Given that ESDs achieve their intended effects by causing an 
aversion with an electric shock, it is not surprising that researchers 
have reported experiencing or observing pain upon ESD application to 
themselves or their patients. For example, one experimenter stated that 
he definitely felt pain when he applied the ESD to himself. He 
described it like a dentist drilling on an un-anesthetized tooth, but 
the pain terminated when the shock ended (Ref. 36). Another report 
observed pain upon stimulation by the ESD (Ref. 35), and another 
observed a tremor in the thigh (Ref. 36). Although ESDs are intended to 
apply an aversive stimulus, and any pain that results from ESDs may 
cause an aversive reaction, pain is nonetheless a harm that should be 
considered in our analysis of risks posed by the device.
    Finally, two articles reported misapplication or device failure 
(Refs. 39 and 65). In such cases, there is a risk that any of the harms 
discussed in this section may occur but without any possibility of 
benefit.
2. Likely Underreporting of AEs
    The Agency's analysis indicates that the medical literature suffers 
from some significant limitations and has likely underreported AEs 
associated with ESDs for a number of reasons. Perhaps most importantly, 
the devices have been studied only on a very small number of subjects, 
many of whom would have difficulty communicating or otherwise 
demonstrating AEs and injuries. The bulk of the articles describe case 
reports or series, employing only retrospective reviews of clinical 
experience, not prospective studies. Further, most of the research 
articles were published in the 1960s and 1970s, before significant 
advances in the ability to diagnose and classify psychological AEs such 
as PTSD. The dated nature of most of the research also means it did not 
adhere to modern standards for AE monitoring. Simply put, researchers 
likely did not report AEs because they had not planned to study them 
separately. None of the articles on the application of ESDs described 
an attempt to assess AEs systematically, and many articles did not 
state whether the authors attempted to assess AEs at all. Finally, 
researcher bias also may have contributed to underreporting of AEs.
    As noted, the literature review suggests some subjects' difficulty 
with reporting AEs due to the subjects' disability likely hindered any 
assessment of AEs, particularly psychological AEs. Since SIB and AB 
often present in individuals with cognitive, intellectual, or 
psychiatric conditions, SIB and AB affect many individuals with 
diminished communication abilities. Patients who exhibit SIB or AB may 
not offer--or providers may not recognize--feedback indicating injuries 
from misfires or other erroneous applications of ESDs. For example, 
conditions such as an autism spectrum disorder may impair expressions 
of pain (see Ref. 66 for a discussion of pain sensitivity and 
expression in autistic individuals). In such a case, an AE could go 
unrecognized because the provider does not understand the individual's 
response, if any.
    Worse, some individuals' impaired ability to communicate, express 
themselves, or associate cause and effect, coupled with the difficulty 
providers may have in distinguishing underlying symptoms from negative 
effects of ESDs, compounds the dangers posed by these devices. This is 
because individuals' impairments with communication or stimulus 
association may prevent the individuals and their health care providers 
from mitigating or avoiding both physical and especially psychological 
harms. (See section II.C.1 for a discussion of interventions that do 
not rely on stimulus association.) In such circumstances, ESDs are 
riskier than for other patients on whom ESDs are used.
    For the reports of AEs that do exist, many of those researchers 
published during the 1960s and 1970s, an era when conceptions of 
disease and how a person's physiology may affect or cause disease, 
i.e., pathophysiology, differed significantly from current medical 
science, particularly psychiatric pathophysiology. As a result, those 
researchers may have interpreted pathological processes differently. 
For instance, they may not have recognized certain currently accepted 
disease processes like acute and posttraumatic stress. Some researchers 
did not report pain or discomfort as AEs since they were considered the 
ESDs' intended result and indicators of effectiveness. (See, e.g., 
Refs. 44 and 57). In short, because science has advanced since much of 
the AE reporting, FDA believes existing AE reports in the literature 
are likely not comprehensive by current scientific and clinical 
reporting standards.
    The Agency's analysis also suggests the possibility of bias against 
reporting AEs. As previously noted, the majority of articles did not 
define a systematic method for assessing AEs. In one review, the 
authors concluded that there was no evidence associating AEs with ESDs 
(Ref. 67). However, the authors went on to opine, ``in light of the 
intrusive nature of shock treatment, it is puzzling that so few 
negative side effects have been reported. In interpreting the existing 
literature, we might be wise to consider the possibility that some 
investigators have been predisposed to see only the positive side 
effects.'' Similarly, the reports of treatment relapse in the 
literature may not reflect the actual prevalence in clinical settings 
because such cases are less likely to be submitted or accepted for 
publication (Ref. 59).
    Potential bias against AE reporting might also have influenced the 
authors of the article that included the largest group of individuals 
(60) subject to ESD application in its retrospective review. The review 
noted only one negative side effect, ``temporary discoloration of the 
skin that cleared up in a few minutes or days'' (Ref. 30). 
However,''temporary emotional behaviors, a temporary tensing of the 
body, or attempts to remove the device or grab the transmitter noted 
during treatment were classified as 'immediate collateral behavior' and 
were not considered adverse events'' (Ref. 30). The lead author of this 
article, Dr. Matthew Israel, may also have been biased in his roles as 
founder of JRC and Chief Executive

[[Page 24396]]

Officer of JRC at the time he co-wrote the article.
    In light of the foregoing, FDA believes that researchers, by 
current clinical and peer-review standards, likely underreported AEs. 
Many patients on whom ESDs have been used have limited ability to 
express themselves. Some earlier studies considered certain reactions 
that we would now consider to be AEs as mere responses or even 
treatment requirements. Even current researchers may classify AEs as 
unwanted side effects that then go unreported. For example, of the 66 
patient case histories spanning 1991 through 2014 that FDA received 
from JRC, none reported any AEs, which is highly unusual for so many 
patients over such a long time (though individual exposure periods 
varied). Nor did any of these case histories include systematically 
defined methods for short- or long-term AE monitoring. Thus, even the 
more recent studies may still reflect outmoded standards. 
Significantly, because much of the relevant literature was published 
many years ago, it does not benefit from recent advancements in 
psychiatric pathophysiology that have expanded researchers' ability to 
identify and record AEs. In light of the foregoing, we conclude that 
realized risks and dangers to individuals' health from ESDs are likely 
greater than reported in the medical literature. As a result, the risks 
posed by ESDs reported by other sources, discussed in the following 
sections, warrant careful consideration.
3. Information and Opinions From Experts
    FDA presented the following dangers to individuals' health related 
to the use of ESDs at the Panel Meeting: Negative emotional reactions 
or behaviors, including aggression; burns and other tissue damage; 
anxiety; acute stress, or PTSD; fear and aversion or avoidance; pain or 
discomfort; depression and possible suicidality; psychosis; and 
neurological symptoms and injury. The panelists generally opined that 
the list was incomplete, and in some cases, too vague and in need of 
clarification (see Ref. 68).\3\
---------------------------------------------------------------------------

    \3\ Unless otherwise noted, all references to statements and 
opinions expressed at the Panel Meeting are taken from Ref. 68.
---------------------------------------------------------------------------

    One panelist noted peripheral nerve injury as a possible side 
effect and was surprised JRC had not reported severe depression, 
especially since ``producing pain in people who have no control over 
the pain'' is ``a perfect paradigm for the learned helpless,'' and 
learned helplessness is used in drug studies ``because it produces in 
animals something analogous to depression and it can be used to test 
antidepressants.''
    Another panelist stated that cardiac effects, renal effects, muscle 
damage, and neurological symptoms, such as neuropathy, could be 
happening at low levels but go unreported because there has not been a 
systematic look at these types of potential injury over the last 40-50 
years.
    Other panelists recommended specific additions and refinements to 
the list of risks and dangers, including: Equipment malfunction; long-
term effects of pain; delineation of range of pain; trauma from falls; 
mistrust of providers; learned helplessness; chronic stress; 
generalized behavioral suppression; small, repetitive damage of other 
tissues; cognitive impairment; neuropathy; ventricular fibrillation if 
the electrodes are placed transthoracically; neuropsychiatric symptoms; 
and emotional sequelae.
    Several Panel members echoed the concerns discussed earlier 
regarding the likelihood of underreporting of AEs. For example, one 
Panel member pointed out that the populations treated with ESDs are 
very vulnerable and may not be able to self-report AEs. Panelists also 
indicated that because clinicians have little understanding of the 
breadth and the range of pain experienced by ESD patients, clinicians 
may mistakenly attribute adverse effects to the patients' cognitive, 
intellectual, or psychiatric conditions rather than to the device. Some 
panelists observed that many of the risks and dangers of ESDs resemble 
co-morbidities in the individuals subject to treatment; as a result, 
adverse effects of the device would be difficult to distinguish from 
symptoms of the disability. This could result in AEs being misperceived 
as underlying symptoms, the likelihood of which is supported by the 
lack of systematic evaluation of AEs in the literature discussed in 
section II.A.2. Panel members similarly expressed concerns about 
communication and diagnosis difficulties exacerbating the harms 
experienced by patients on whom ESDs are used.
    In his expert report, Dr. Smith explains that ESDs for SIB or AB 
``necessarily involve inflicting pain on a person with [an intellectual 
or developmental disability],'' and notes the risks of fear and 
agitation observed in one study. Dr. Smith details several limitations 
to the studies on ESDs in the literature, including the failure of any 
of the studies to have a prespecified, systematic plan for monitoring 
AEs, which may have resulted in underreporting of AEs. He also 
discusses the possibility that the publication process may also 
introduce a bias against reporting AEs in the retrospective single-
patient studies relied on by many researchers of ESDs. This is because, 
according to Dr. Smith, when studying only one patient, researchers 
tend to emphasize data that epitomize experimental control rather than 
an average response to the device (Ref. 8). Further, researchers 
generally tend to publish clear-cut results rather than less-clear 
outcomes (Ref. 8). Although he notes that the ``overall strength of 
evidence is low'' with respect to both benefit and harm, Dr. Smith 
concludes that ``existing evidence shows that aversive conditioning 
with electric shock can be safe and effective in at least some cases, 
but that it can also be misapplied, risking severe, negative 
consequences'' (Ref. 8).
    A comment submitted by the Disability Law Center includes a 2014 
expert affidavit from Dr. James Eason, a university instructor of 
biomedical engineering with a Ph.D. in biomedical engineering and a 
B.S. in electrical engineering who has particular expertise on ICDs 
(Ref. 69, attachment 2). Dr. Eason opines on the potential hazards 
posed by three ESDs: The SIBIS (cleared by FDA in 1986), the GED-1 
(cleared by FDA in 1994), and the GED-4 (not FDA cleared or approved). 
Focusing on peak current, based on his views on the relationship 
between certain electrical stimulus parameters and pain, Dr. Easton 
compares the SIBIS (4.1 mA), GED-1 (30 mA), and GED-4 (90 mA), with an 
electrical fence (4 mA), a dog training collar (2-4 mA), and a cattle 
prod (10 mA), respectively.
    Dr. Eason opines that, when applied to non-sensitive locations such 
as the arm or leg, the SIBIS shock falls below the range usually 
considered painful; the GED-1 shock falls within the range of pain 
thresholds, meaning some would find it painful and some may not; and 
the GED-4 shock would be painful or extremely painful to anyone. 
According to Dr. Eason, when the electrodes are placed on sensitive 
parts of the body, such as hands, feet, underarms, torso, or neck, all 
three ESDs are capable of inflicting extreme pain on anyone. Dr. Eason 
explains that sweating, which may be caused by stress or anxiety about 
receiving a shock, lowers skin resistance, which in turn may lower 
one's pain threshold, and that one's pain threshold may also be lowered 
by repeated shocks. He further concludes all three devices are capable 
of producing tissue damage due to strong muscle contractions, and all 
are capable of causing superficial skin burns under certain 
circumstances.

[[Page 24397]]

    Dr. Eason also concludes that the ESDs ``are likely to induce an 
immediate increase in physiological stress ranging from mild to severe. 
Further, the long-term effects of receiving numerous painful and 
uncontrollable shocks will be an increased risk for developing ASD or 
PTSD.'' His conclusion is based partly on observations of people who 
have ICDs, which have been shown to induce psychological trauma, 
including PTSD, as discussed in section II.A.1. Finally, Dr. Eason 
believes the GED-4 presents a risk of heart palpitations, long-term 
psychological disorders, and neurological effects.
    Dr. Eason's expert opinion is consistent with other available data 
and information demonstrating that ESDs can be painful, particularly 
when placed on sensitive areas, and that physiological and 
psychological factors contribute to the experience of pain. However, as 
explained in section I.C, because an individual's experience of pain 
varies significantly based on many factors, pain predictions based on 
peak current are subject to considerable uncertainty. As such, although 
higher peak currents correspond to greater risks of physical illness or 
injury, the peak current is but one factor in an individual's 
experience. Similarly, pain is but one risk of physical harm that ESDs 
pose. The devices pose serious risks of other short- and long-term 
psychological and physical harms, as discussed in the literature and at 
the Panel Meeting.
4. Information From State Agencies and State Actions on ESDs
    FDA reviewed complaints regarding ESD use made to the Massachusetts 
Disabled Persons Protection Committee (DPPC) from August 30, 1993, to 
July 28, 2013. Of 53 complaints, DPPC screened out 18 as not meeting 
complaint criteria; DPPC found 22 more were unsubstantiated. The 
remaining 13 complaints described the following AEs: Burns or tissue 
injury (6 reports), inappropriate device use (3 reports), negative 
emotional reactions (3 reports), and PTSD (1 report).
    In 2007, the Massachusetts Department of Early Education and Care 
(DEEC) conducted an investigation of JRC's Stoughton Residence, where 
GED devices were used on individuals living there (Ref. 70). According 
to the Investigation Report, an individual reported waking up because 
his roommate was screaming; his roommate had been asleep but was 
shocked by a GED, waking him and causing him to scream. JRC staff 
reported that ``the skin was off of the area'' of the leg where GED 
shocks had been applied, that the GED was removed from the leg 
``because the area on was too bad to keep the device,'' and either the 
individual who received the shocks or the staff (it is not clear who) 
believed a stage two ulcer was in the area where skin was missing (Ref. 
70).
    In 2006, the New York State Education Department (NYSED) conducted 
an onsite review of JRC's behavior intervention programs, with purposes 
including identification of any health and safety issues relating to 
JRC's use of aversive interventions (Ref. 71). The review was conducted 
by NYSED staff and three behavioral psychologists serving as 
independent consultants. It included a review of school policies, 
student records, observations of school and education programs, and 
interviews with staff and randomly selected individuals living at JRC. 
The reviewers witnessed staff rotating GED electrodes on individuals' 
bodies at regular intervals to ``prevent burns that may result from 
repeated application of the shock to the same contact point'' (Ref. 
71).
    During interviews, individuals reported ``pervasive fears and 
anxieties related to the interventions used at JRC,'' which include 
other interventions in addition to the GED devices. Although not 
reported as relating specifically to GED use, one patient stated she 
felt depressed and fearful, that her greatest fear was having to stay 
at JRC past her 21st birthday, and that she thought about killing 
herself every day. The review notes various other potential negative 
effects that may result from aversive behavioral strategies, such as 
depression, social withdrawal, aggression, and worsening of PTSD 
symptoms in individuals diagnosed with PTSD, though it did not report 
any specific instances of these adverse effects related to GED use.
    NYSED also submitted a comment to the 2014 Panel Meeting docket 
stating that it has received reports of collateral effects from the use 
of these devices, such as increases in aggression and increases in 
escape behaviors or emotional reactions. NYSED states it has received 
``numerous reports of students who have incurred physical injuries 
(burns, reddened marks on their skin) as a result of being shocked and 
for whom parents and students themselves have reported short-term and 
long-term trauma effects as a result of use of such devices or watching 
other students being shocked (e.g., loss of hair, loss of appetite, 
suicidal ideation).'' NYSED believes it is well established that stress 
and trauma impair brain functioning. According to NYSED, one student 
explained, ``I am scared and sometimes I feel like my life is in 
danger. There are days when I am scared to even say a word to anyone. I 
am afraid to wake up because I never know what is going to happen to 
me. I think I should not have to live in fear and be scared . . . I get 
so depressed here I wish my life by fast'' (Ref. 72).
5. Information From the Affected Manufacturer/Residential Facility
    JRC acknowledges the risk of physical harms to the skin, that ``in 
rare cases, mild erythema of the skin may result'' that disappears 
within an hour to a few days, ``less than 1% of applications result in 
<1 mm lesion,'' and ``it is possible that repeat exposure to the GED 
skin-shock could result in blistering'' (Refs. 21 and 73). With respect 
to psychological adverse effects, JRC states, ``there also may be 
brief, temporary anxiety just prior to the delivery of the application 
as well as occasional harmless avoidance responses (e.g., tensing of 
the body, attempts to remove the electrode in some cases)'' (Ref. 21). 
JRC also acknowledges that, ``in very rare circumstances, the GED may 
errantly deliver an unintended skin-shock to a patient,'' either when 
the shock is delivered to the wrong patient or due to spontaneous 
activation (Ref. 73).
    In line with the decades-old research that considered pain or 
discomfort to be merely an indicator of effective treatment (see 
section II.A.2), JRC does not include pain in its discussion of AEs 
caused by the device. Two tables provided by JRC in one of its 
submissions suggest its GED devices may not cause pain based solely on 
their peak current levels (Ref. 21). However, as discussed in section 
I.C, conclusions regarding pain based on peak current alone are 
difficult to draw, and the stimulus-pain matching tables in some of the 
sources cited by JRC are not based on shock sources akin to ESDs. JRC 
elsewhere acknowledges ``the stimulation may be considered painful by 
some patients'' (Ref. 73), and when asked directly whether the stimulus 
causes pain at the Panel Meeting, Dr. Nathan Blenkush, JRC's Director 
of Research, answered ``yes.''
    Except for the harms described earlier, JRC maintains that it ``has 
not found any side effects associated with aversive conditioning'' 
(Ref. 21) and ``there are no confirmed reports or confirmed medical 
evidence that patients have any negative psychological side effects 
related to any discomfort experienced due to therapy with the proper 
use of the GED devices'' (Ref. 73). FDA's review of records collected 
as part of a 2013 inspection of

[[Page 24398]]

JRC did not reveal any AEs reported by JRC for individuals with ESDs. A 
former JRC clinician commented that he ``did not observe any permanent 
negative side effects'' (Ref. 74). JRC concludes, ``the medical 
literature cited by FDA [in the FDA Executive Summary for the Panel 
Meeting] did not show any evidence of profound, sustained, or 
significant harm or patient injuries resulting from use of ESDs'' (Ref. 
21).
    However, with respect to psychological harms, JRC's records provide 
compelling evidence of risks of such harms that may result from GED 
use. For example, a JRC document entitled, ``Procedures to Facilitate 
the Assessment of Possible Collateral Effects,'' dated June 14, 2012, 
directs staff to note ``any sign of any adverse effect on the student 
that may be resulting from the use of aversive interventions,'' and 
``look for any collateral effects that may be related to the 
administration of an aversive intervention.'' The collateral effects 
listed in the JRC document include, but are not limited to: Nightmares, 
intrusive thoughts, avoidance behaviors, marked startle responses, 
mistrust, depressions, flashbacks of panic and rage, anger, 
hypervigilance, and insensitivity to fatigue or pain. The corresponding 
section of the training manual headed ``Responding to Collateral 
Effects'' further directs staff to look for ``signs of any form of 
distress or discomfort,'' including but not limited to: Changes in 
sleep patterns, loss of appetite, confusion, irritability, lack of 
energy, sadness, mood swings, significant weight loss, loss of 
interest, fatigue and lack of energy, difficulty concentrating, 
agitation, restlessness, or irritability, withdrawal from usual 
activity, and feelings of helplessness. Another JRC document entitled 
``Pre-Service Training Manual,'' dated September 11, 2012, contains the 
same information.
    Although the patient records submitted by JRC do not indicate 
occurrences of any of these harms, and JRC's comments claim they 
adequately train their staff, monitor individuals on ESDs, and report 
adverse events, FDA has reason to doubt that none of these harms 
occurred. As discussed earlier, impairments with patient communication 
and provider recognition pose difficulties in identifying harms caused 
by the device, even for vigilant staff. State agencies in Massachusetts 
and New York have reported problems with staff supervision of 
individuals and monitoring of adverse events at JRC. For example, the 
2006 NYSED review of JRC's program found that the collateral effects of 
punishment ``are not adequately assessed, monitored, or addressed,'' 
and ``[t]here does not appear to be any measurement of, or treatment 
for, the possible collateral effects of punishment such as depression, 
anxiety, and/or social withdrawal.'' Further, ``[s]kin shock has the 
potential to increase the symptoms associated with PTSD, yet there is 
no evidence of data measuring these possible side effects or therapies 
designed to treat these symptoms'' (Ref. 71). The 2007 Massachusetts 
DEEC investigation resulted in several determinations of deficiencies 
in patient oversight at one of JRC's residential facilities, including 
lack of necessary training and experience among staff, problems 
regarding communication of medical issues, monitoring staff neglect of 
responsibilities that ``compromis[ed] the supervision and the safety of 
residents,'' and staff failure ``to monitor the residents in a manner 
that assured their health and safety'' (Ref. 70). Given these findings, 
patient records may well fail to capture occurrences of harms.
6. Information From Patients and Their Family Members
    Although three individuals formerly at JRC who spoke at the Panel 
Meeting either did not mention any harms or stated the GED did not harm 
them, two other individuals formerly at JRC described a variety of 
harms related to their experience with the GED, including panic and a 
fear of authority and being controlled, severe muscle cramps that would 
last 1 to 2 days, skin burn marks, terrible pain from the site of GED 
application on the leg down to the foot, loss of sensation in the leg 
and skin, frequent misfires, nightmares, freezing up upon hearing 
certain sounds associated with GED application, and flashbacks.
    Three individuals formerly at JRC interviewed by FDA clinicians 
asserted the following additional serious AEs resulting from GED use: 
Heart palpitations, seizure, depression, and suicidality. These 
individuals described the GED shock as ``a thousand bees stinging you 
in the same place for a few seconds,'' a ``bad bee sting,'' and 
``extremely painful,'' and gauged the pain level from 5 to 8, depending 
on the GED model and the location of the shock on the body.
    Some of the relatives of individuals at JRC who spoke at the Panel 
Meeting only spoke about the positive effects of the GED devices and 
did not recount any adverse effects. Family members of individuals at 
JRC and a JRC parent association also commented that individuals at JRC 
have not suffered any side effects from the GED devices (see, e.g., 
Ref. 75). However, one parent of an individual formerly at JRC 
described the following adverse effects from use of the GED: Burns, 
fear, pain, PTSD, catatonia, and deep vein thrombosis caused by 
catatonia.
7. Information From Other Stakeholders
    At the Panel Meeting, organizations concerned with the treatment 
and rights of individuals with disabilities cited risks of the 
following harms posed by ESDs based on first- or second-hand accounts: 
Pain, fear, anxiety, panic, depression, attempts to avoid or escape, 
nightmares, hyperarousal, flashbacks, burns, scars, loss of sensation, 
muscle contractions, learned-helplessness responses, nerve damage, 
muscle cramps, soreness, and neurological injuries such as seizures. 
The presenters stated that, in some cases, ESDs hindered the 
development of the very skills and behaviors necessary to control SIB 
or AB.
    The written comments from disability rights organizations, as well 
as health care professionals and other concerned citizens, identified 
the following risks based on first- and second-hand accounts of the use 
of ESDs: PTSD and other effects on brain function from stress, 
including memory loss, loss of verbal communication, and sleep pattern 
disturbances; severe psychological trauma; depression with possible 
suicidal ideation; anxiety; increase in aggression; increase in escape 
behaviors and emotional reactions; fear and aversion or avoidance; 
seizures; migraine headaches; burns or red marks on the skin; loss of 
hair; loss of appetite; pain; misuse of the device (misfires and 
erroneous applications); persistent numbness and other neurological 
injuries; and ear problems.
    One comment from a disability rights group cites a media report 
quoting an expert in a lawsuit filed by a parent of an individual 
formerly at JRC against JRC, describing the individual's state after he 
was shocked repeatedly with a GED device: ``He was essentially in what 
we would call a catatonic condition . . . That means a condition that 
happens with people that are acutely psychotically disturbed'' (Ref. 
76).
    Another comment from a psychologist, who has worked with patients 
exhibiting SIB and AB, reports witnessing patients waking up screaming 
from nightmares, which only happened after ESDs were used on them. The 
psychologist reported that other patients have ``waking nightmares, in 
which horrible memories of shock, pain, and restraint suddenly overcome

[[Page 24399]]

them, even during an otherwise happy event'' (Ref. 77).
8. Conclusion
    Based on the scientific literature regarding ESDs for SIB, AB, and 
other unwanted behaviors, and regarding aversive conditioning 
generally, FDA has determined that ESDs for SIB and AB present the 
following risks: Depression; fear; escape and avoidance behaviors; 
panic; aggression; substitution of other behaviors such as freezing and 
catatonic sit-down; worsening of underlying symptoms, such as increased 
frequency and bursts of self-injury; pain; burns; tissue damage; and 
device misapplication or failure. Based on the scientific literature 
regarding ICDs, FDA has determined that ESDs for SIB and AB also 
present the risks of PTSD or acute stress disorder, shock stress 
reaction, and learned helplessness. This literature also provides 
support for the risks of depression, anxiety, fear, and pain.
    Experts in the field of behavioral science and State agencies that 
regulate ESD use provide further support for the risks of depression, 
PTSD, learned helplessness, fear, anxiety, substitution of collateral 
behaviors, pain, burns, tissue damage, and inappropriate use. They 
indicate ESDs have been associated with the additional risks of short- 
and long-term trauma including suicidal ideation, chronic stress, acute 
stress disorder, neuropathy, heart palpitations, and trauma from 
falling. JRC's internal policies include long lists of risks for 
aversives they use. Although these are not specific to ESDs, FDA finds 
these lists further support that ESDs pose the risks of depression, 
fear, anxiety, panic, learned helplessness, and substitution of 
collateral behaviors, and they support that ESDs are associated with 
the additional risks of nightmares, flashbacks, hypervigilance, 
insensitivity to fatigue or pain, changes in sleep patterns, loss of 
interest, difficulty concentrating, and withdrawal from usual activity. 
Comments from individuals on whom ESDs have been used, their family 
members, disability rights groups, and others, provide additional 
support for the risks previously identified, and suggest ESDs may pose 
the additional risks of severe psychological trauma, catatonia, 
seizures, nerve damage, loss of sensation and numbness, migraine 
headaches, impaired brain function due to stress, memory loss, and 
muscle cramps.

B. Effect on Targeted Behavior

1. Scientific Literature
    FDA conducted an extensive, systematic review of the medical 
literature for information assessing the clinical benefits of the use 
of ESDs for SIB or AB. We identified a total of 45 studies, including 
41 case reports or case series, a case-control study conducted outside 
the United States (Ref. 29), a within-subjects comparison trial 
conducted outside the United States (Ref. 78), a retrospective review 
of 60 patient charts (Ref. 30), and a questionnaire followup study of 
22 subjects on whom ESDs were used for aversive conditioning (Ref. 79). 
(See table 3 of Ref. 3 for a summary of these 45 studies.) The 45 
referenced studies showed that ESDs can have some immediate impact on 
the targeted behaviors in some patients, i.e., they interrupted the 
target behavior.
    We also evaluated 12 articles reviewing some of these 45 studies 
that included specific clinical information on individual subjects and 
examined the effectiveness of ESDs for various pathologies, e.g., AB, 
SIB, or problematic behaviors more generally. (See Ref. 3 for 
additional details.) These reviews generally support the conclusion 
that ESDs used on patients exhibiting SIB or AB caused the immediate 
cessation of the target behavior in some patients.
    One review article specifically examined reports of applying ESDs 
to autistic children (Ref. 57). The authors noted that ``in all of 
these studies, electric shock proved to be a highly effective 
therapeutic agent with autistic children.'' They estimated that 
positive effects compared to negative effects occurred at a ratio of 5 
to 1. However, they also reported that setting-specificity (the 
specific setting affects the results) may be an obstacle to an overall 
satisfactory effect (see also Ref. 44). Similarly, a comparison of 
different treatments for controlling behavior in individuals with 
intellectual impairments or schizophrenia noted that, in terms of 
immediate effects, ``punishment was the quickest means of suppressing 
behavior'' (Ref. 80; see also Ref. 36). These studies show that ESDs 
can interrupt SIB or AB, causing an immediate cessation of the 
behavior.
    One study observed that a patient adapted to the stimulus intensity 
(Ref. 29), and another study showed that the application of ESDs can 
lead to adaptation (e.g., Ref. 36). Adaptation means that a patient no 
longer responds at a particular level of stimulation--in the case of 
ESDs, a particular shock strength--though the evidence is inconclusive 
as to whether this occurs. Some, including JRC, believe that adaptation 
occurs, and that when an individual adapts, the shock strength must be 
increased in an attempt to achieve the same effects. However, experts 
in the field, including at the Panel Meeting discussed in section 
II.B.3, have explained that what has been characterized as adaptation 
is really evidence of ineffectiveness, regardless of shock strength. 
Thus, for some individuals, shocks are ineffective, including with 
respect to immediate interruption or cessation of the target behavior.
    Twenty-two of the 45 literature studies reported on durability of 
the effects of ESDs (Refs. 29, 30, 34, 36, 39, 40, 46, 50, 65, 79, and 
81-92). A durable effect is one where an individual develops a 
conditioned response, so the target behavior, along with the numbers of 
shocks, is greatly reduced either while the individual continues to 
wear the ESD or after the ESD is removed. Twenty of the studies 
reported a durable effect that lasted from months to years. Two of the 
22 studies reported no durability (Refs. 50 and 92). However, all 22 
suffer from various flaws and limitations, as described in the next 
section.
    Several of the literature reviews, which include reviews of many of 
these 45 studies, made observations regarding durability. One review 
opined that the use of ESDs might have long-term durability and 
concluded that results of aversive conditioning studies ``suggest that 
sufficiently intense punishers . . . may produce lasting reductions in 
problem behavior'' (Ref. 59). However, this conclusion included the 
qualifier, ``as long as the punishment contingency remains in effect,'' 
which implies that the authors were not discussing behavioral 
conditioning durability after the removal of the punisher. The authors 
also noted several limitations on the studies' findings. Importantly, 
the available studies had methodological limitations that prevent 
generalizing research findings to a treatment setting (Ref. 59). One 
major limitation is that, because of the long duration of the studies, 
unplanned changes or other uncontrolled conditions hinder attributing 
observations to ESDs. The authors concluded that, ``[u]ntil additional 
research on long-term maintenance is conducted, practitioners and 
caregivers should not assume punishment will remain effective over the 
long run'' (Ref. 59).
    Other reviews were much more doubtful regarding the durability of 
ESD effects. One of the reviews discussed earlier in this subsection 
reported that,

[[Page 24400]]

``[i]n marked contrast to [short-term effects], punishment and 
extinction programs seemed to have the least durable success'' of any 
of several behavioral treatments reviewed (Ref. 80). Another review 
discussed earlier in this section reported that one author expressed 
dissatisfaction with the lack of long-term durability (Ref. 57), and 
another review similarly noted that the effect appeared to be short-
term only, i.e., symptoms are only ``momentarily suppressed'' (Ref. 
55). A more recent review found that research into durability has 
continued to lag (Ref. 93). See section II.C describing the state of 
the art for a more comprehensive explanation of the reasons that the 
research has lagged.
2. Literature Limitations
    The medical literature described in the previous section on the 
effect of ESDs on SIB and AB suffers from a number of deficiencies that 
limit confidence in the results. Most importantly, study design 
deficiencies render these studies inadequate to draw any definitive 
conclusions. As discussed in the previous section, 41 of the 45 studies 
that the Agency's analysis identified were case reports or series, 
which have limited evidentiary value in this patient population, as 
discussed in the paragraphs that follow. Another study was a 
retrospective analysis of patient charts (Ref. 30) that suffers from 
various flaws, discussed later in this section. Another study reported 
results from a questionnaire sent to 22 authors of case series 
publications, of whom only 11 responded (Ref. 79), used an unscientific 
sampling method (questionnaires were sent only to authors of published 
articles, some published more than 5 years prior), and asked questions 
that do not constitute validated measures of effects. The one 
prospective case-control study examining ESDs for SIB and AB (Ref. 29) 
only included 16 subjects (8 in the device group and 8 in the control 
group) and did not use a direct measure of SIB or AB as the primary 
outcome (instead, it measured a decrease in mechanical restraint). 
Finally, the within-subjects comparison study looked at heart rate 
changes as a measure of stress in five subjects, and it showed that 
active treatment with ESDs correlated to a statistically lower mean 
heart rate than when subjects were not wearing the ESD (Ref. 78). The 
authors surmised that heart rate was an indicator of stress but this 
correlation has not been demonstrated to be a valid marker of anxiety, 
and direct measures of reduction in SIB and AB were not taken. No 
randomized controlled trials directly examined ESDs for SIB or AB.
    Generally, a study's strength or weakness is related to design in a 
number of ways, particularly through randomization, control, and the 
number of study subjects. Randomization distributes characteristics 
that could affect the results evenly across conditions. This equalizes 
the influence of nonspecific processes not under study, e.g., the 
effects of participating in a study, being assessed, receiving 
attention, or self-monitoring. Control conditions attempt to subtract 
other influences to ensure observations do not have alternative 
explanations. They enable a comparison to a baseline in order to 
distinguish effects, if any, of the device being studied. A larger 
number of subjects provides greater confidence that the same results 
can be expected for any given person under the same conditions. 
Randomization and controls allow the researcher to determine cause-and-
effect, as opposed to mere coincidence, with greater confidence. As a 
general rule, these study design features improve the strength of 
conclusions, which is particularly useful in cases with potentially 
significant confounding factors, subtle outcomes (including AEs), or 
potential bias.
    In most cases, a study that is not randomized, controlled, 
inclusive of a sufficient number of subjects, or that suffers from more 
than one of these deficiencies, will yield weaker conclusions, and thus 
more uncertain predictions. Studies that fail to account for AEs will 
also yield weaker conclusions with respect to the benefit-risk profile, 
because such a study would not fully account for the risks.
    In the case of ESDs used for SIB or AB, randomization, control, 
large numbers of subjects, and AE reporting are critical to 
understanding the benefit-risk profile. Many factors contribute to the 
manifestation or reduction of target behaviors and therefore can be 
significantly confounding. Those factors may include, but are not 
limited to, the underlying condition, environmental cues, transient 
psychological and physical states, and the treatment plan details. ESDs 
used for SIB or AB may also produce subtle outcomes, especially when 
the individual has intellectual or developmental disabilities that can 
impair communication. Subtle outcomes may include, but are not limited 
to, the development of stress disorders, fear and anxiety, pain and 
suffering, or learned helplessness. In light of such circumstances, 
drawing conclusions about the effectiveness of ESDs for SIB and AB, 
especially with respect to durable conditioning, is difficult in the 
absence of randomized controlled trials.
    In a randomized controlled trial, the researcher will randomly 
assign each subject to one group, at least one of which is a control 
group. A randomized controlled trial is prospective; the researcher 
creates different conditions across groups at the outset and will 
observe outcomes in the future. The researcher will eventually compare 
the outcomes across groups, with the control group providing confidence 
that the researcher-set conditions were responsible for any 
differences. A randomized controlled trial is one of the best designs 
for strong conclusions in most cases, including the use of ESDs for SIB 
and AB. In reviewing all the evidence, FDA did not identify any 
randomized controlled trials studying the effects of ESDs for SIB or 
AB.
    Other designs are often considered to provide weaker evidence, 
which is the case for ESDs used for SIB and AB. For example, a case-
control study is usually considered to be weaker because it does not 
observe randomized subjects but, instead, retrospectively compares two 
types of subjects (one acting as the control) by observing different 
outcomes and working backwards to explain the cause of one set of 
outcomes. Retrospective reviews are often considered weaker still 
because they do not include a control group. Case reports or series are 
even weaker because they report on, and attempt to explain, the 
experiences of single individuals.
    Conclusions drawn from these other designs are generally considered 
weaker because they do not rule out other causes for any differences in 
results, including subject selection bias, as effectively. Designs that 
take an outcome as given and then work backwards in an attempt to 
explain it are more vulnerable to bias than prospective designs. 
Single-subject designs such as case studies are less likely to yield 
outcomes that would be typical for other such subjects. The conclusions 
drawn from randomized controlled trials are therefore generally 
considered much more reliable than these other designs. The general 
rule applies to ESDs used for SIB or AB because of the known multiple 
confounding factors, possible subtle outcomes (including unassessed 
AEs), and because bias is of particular concern. Thus, the reliance on 
weaker study designs for trials on ESDs limits the conclusions that may 
be drawn regarding their effectiveness.
    Other weaknesses stem from the fact that the majority of research 
articles

[[Page 24401]]

were published in the 1960s and 1970s. Specifically, researchers 
published 26 articles before 1980, 12 from 1980 to 2000, and 7 since 
2000. Consequently, most of the articles do not adhere to current, more 
exacting peer-review standards for study conduct and reporting. This is 
evident not only from the time of publication but from the information 
provided regarding study design, conduct, and reporting. (See also 
section II.A.2, discussing likely underreporting of AEs.)
    Some of the papers have significant methodological limitations in 
addition to those already discussed. For example, the 2008 review by 
Dr. Israel and colleagues (Ref. 30), which provides a retrospective 
analysis of 60 subjects purporting to show all achieved successful 
treatment (defined as at least a 90 percent reduction in the targeted 
behavior), failed to explain, among other standard disclosures, data 
collection procedures, whether it was retrospective or prospective, and 
why and how staff made certain decisions that differed from patient to 
patient (e.g., the number of GED electrode sets applied). In short, 
that review did not take certain standard precautions that help to 
identify and eliminate bias and variability in order to understand 
results objectively.
    A 2010 review by Dr. Israel and colleagues is a series of case 
reports on seven individuals at JRC (Ref. 94). The authors investigated 
the addition of punishment-based techniques to behavioral modification 
plans for people for whom positive-only techniques and pharmacotherapy 
had been reported to have failed previously, and reported success from 
skin-shock treatment at JRC. A review of case reports could be useful 
to examine initial results for continued investigations of an 
intervention; however, it was retrospective and covered few subjects. 
The authors also failed to describe how they chose the specific case 
reports, meaning that the authors may have overlooked or omitted 
individuals for whom punishment-based techniques did not affect the 
outcome. In contrast, studies that do not suffer from such 
methodological limitations have found that the removal of punishment 
techniques did not lead to an increase in problem behaviors (e.g., Ref. 
95).
    A paper by Dr. van Oorsouw and Dr. Israel, et al. investigated the 
effects of GEDs, but it too suffered from significant limitations (Ref. 
96). The authors claim that contingent shock (another term for aversive 
conditioning with ESDs) significantly improved some individuals' 
behaviors; however, in each of the categories measured, no more than 
four out of nine subjects demonstrated improvement. The other subjects 
``did not show any change.'' Regarding measurements, the investigators 
apparently included ``soft'' neurological signs and symptoms, 
especially involuntary movements, which are common for individuals who 
exhibit SIB or AB. They apparently applied shocks for such involuntary 
movements even though the patients would not be able to consciously 
control those behaviors. The investigators also appeared to consider 
certain behaviors, such as refusing academic tasks, as target behaviors 
even though such behaviors are not clinically considered aggressive or 
self-injurious. Thus, the related results do not actually reflect the 
use of the devices for SIB or AB. Additionally, the investigators 
studied a small group with highly varied characteristics, e.g., 
intellectual capacity and primary diagnoses. Such high variability 
among so few patients suggests that the investigators may not have 
obtained results that could be generalized to other patients, even 
without the aforementioned deficiencies.
    Further, the 2008 and 2010 reviews by Dr. Israel and colleagues 
were published in The Journal of Behavioral Analysis of Offender and 
Victim Treatment and Prevention (JOBA-OVTP). JOBA-OVTP no longer 
appears to exist, and we determined that when it was active, it was not 
a peer-reviewed source because the articles were only reviewed by the 
journal's editorial board rather than an expert whose sole role was to 
verify accuracy and validity. Failure to conduct peer review indicates 
that the source is unreliable because its articles were not subjected 
to independent expert critiques that help ensure unbiased, evidence-
based conclusions.
    FDA also identified conflicts of interest relevant to some of the 
articles. While possible conflicts of interest do not on their own 
discredit results, certain safeguards help maintain the credibility of 
the authors. Authors commonly disclose possible conflicts in their 
papers, allowing readers to consider the information accordingly, and 
authors do not normally decide whether to accept their own papers for 
publication. However, FDA has particular concern with the bias that may 
have influenced many of the papers about the effects of ESDs on SIB or 
AB. For example, Dr. Israel, the founder of JRC, was an author of 
several of the 45 articles; Dr. Blenkush, the facility's Director of 
Clinical Research, has co-authored several papers with him. At the time 
some of those papers were published in JOBA-OVTP, Dr. Israel was on the 
journal's editorial board and thus part of the reviewing and approving 
body. Considering the lack of peer review of these papers, any 
potential bias, intentional or not, in favor of the company or Dr. 
Israel's personal interests apparently went unquestioned before 
publication. In addition, without the expected conflict disclosures, 
readers were not adequately notified of any potential bias, which could 
affect their interpretation of the papers in consideration of the 
source.
    The evidence in the scientific literature of the effects of ESDs on 
individuals' SIB or AB is therefore generally weak, and it is 
particularly weak with respect to the effectiveness of ESDs in 
achieving durable, long-term conditioning. This is not only because 
fewer studies considered long-term effectiveness, but more importantly, 
these studies failed to control for other treatment interventions 
applied over time, meaning that any effects observed may or may not 
have been due, in whole or in part, to ESDs. Thus, although the 
scientific literature indicates some individuals may stop engaging in 
the target behavior as an immediate effect of ESD application, the 
serious limitations discussed previously mean that durable long-term 
conditioning has not been established.
3. Information and Opinions From Experts
    The Panel Meeting convened by FDA to consider the benefits and 
risks of ESDs generally held opinions consistent with our review of the 
literature. When asked whether the evidence presented at the Panel 
Meeting demonstrates that ESDs provide a benefit, the Panel was 
divided. However, approximately half the Panel agreed that there was a 
benefit, but they qualified their answers by explaining that the 
evidence showed a benefit from the interruption and immediate cessation 
of the target behavior. They noted the weaknesses in the evidence, 
including some of the limitations discussed previously. Three panelists 
were undecided, with one indicating that anecdotal reports suggest 
benefit for an ill-defined subpopulation. About one-third of the Panel 
answered no, the evidence does not show that ESDs provide a benefit to 
patients; they cited the poor quality of the evidence, the lack of 
recent data, and the failure to examine long-term effects.
    At the Panel Meeting, one of the experts in the field observed that 
intervention with an aversive stimulus should not entail increasing the 
intensity, especially with ESDs, and that what might be characterized 
as adaptation or habituation to a particular

[[Page 24402]]

shock level actually indicates that skin shock is ineffective for that 
individual. As he explained, ``the way this whole process works is that 
within a given range in terms of interventions that we use, some are 
effective and some are not, and if they're not effective, you go on to 
something else. . . . To use an analogy, a small amount of lemon juice 
might be another aversive event, but if that doesn't work, we don't put 
acid on the tongue.'' With respect to ESDs, because the shock is 
designed to be effective very quickly, when it appears an individual 
has habituated to the stimulus, ``it's not really habituation; that is, 
they haven't adapted to it. It's simply ineffective, and you would move 
on rather than to step up the voltage, so to speak.'' Thus, what may be 
characterized as adaptation to a particular ESD shock level would be 
evidence of ESD ineffectiveness regardless of shock level.
    Pointing to evidence FDA has considered, Dr. Tristram Smith's 
expert opinion characterizes the results of the studies on aversive 
conditioning with electric shock as ``highly favorable,'' indicating 
that aversive conditioning reduces or eliminates severe SIB and 
aggression. As discussed in section II.A.3, he concludes that ESDs can 
be effective in at least some cases, but he is careful to note that the 
overall strength of the evidence is low (Ref. 8). Dr. Smith highlights 
many of the same evidentiary limitations discussed earlier, especially 
that the results may not be generalizable because they are based on 
small numbers of subjects and seldom provided information on key 
parameters, including recruitment, retention, standardization of 
measures, and participants' treatment history. Dr. Smith echoes the 
concerns discussed earlier that the ability to reproduce the studies' 
results in clinical practice is unclear because of differences between 
medical research and treatment settings, and notes that publication 
bias weighs in favor of reporting a clear effect on SIB and AB, since 
reports of clear effect are more likely to be published (Ref. 8). 
Finally, he observes that most of the few available studies have only 
evaluated short-term effectiveness and not long-term outcomes.
4. Information From State Agencies and State Actions on ESDs
    According to NYSED, in 2006 it promulgated regulations to prohibit 
future use of ESDs in public and private schools serving New York State 
students, and require review of each student who continued to receive a 
behavioral intervention with an aversive conditioning device by 
independent panels of three behavior experts. NYSED reports that, ``in 
almost every instance over a 6-year period of time, these panels have 
determined after reviewing student-specific information that use of 
such a device was not warranted.'' The panels ``consistently reported 
that the data presented regarding the use of an aversive conditioning 
device lacked evidence of effectiveness.'' NYSED also found that the 
long-term use of ESDs further demonstrates the lack of efficacy. 
Specifically, many students remain subject to ESDs for several years, 
and many continue to receive shocks long into their adult lives. In 
2006, NYSED documented that 17 New York citizens remained subject to 
ESDs for 3 to 7 years (Ref. 72).
5. Information From the Affected Manufacturer/Residential Facility
    JRC asserts that its ESDs provide substantial benefits to 
individuals by causing a meaningful decrease in the aggression, self-
injury, or other harmful behaviors they exhibit, and that the 
literature evidences more positive side effects than negative ones. JRC 
representatives have stated that they have observed multiple positive 
side effects: The individuals ``are no longer a threat to themselves or 
others. They are happy, they are healthy, they are medication and 
restraint free, and for the first time in their lives they are 
learning.'' In many individuals, JRC staff ``see a dramatic improvement 
in the affect and the way that they present. Many of them are able to 
receive medical treatment that they wouldn't otherwise have been able 
to receive. They're able to enjoy time with their family.''
    Regarding the effectiveness of the devices in conditioning 
patients' behavior, the JRC representatives stated at the Panel Meeting 
that, of 83 individuals whose treatment plans included use of the GED 
devices, 12 no longer wear the devices, 11 additional individuals have 
stopped using ESDs altogether, and 6 have not received any applications 
in the past 6 months. The representatives gave a detailed account of an 
individual who they claim was successfully treated with a GED device. 
In their view, banning ESDs would mean many individuals ``are going to 
go back to the state of being restrained, of losing access to 
education, and are going to lose access to the vocational progress they 
have made, and they are going to return to a life of mechanical 
restraint and high doses of drugs.''
    In its comments to the docket for the Panel Meeting, JRC submitted 
patient data purporting to demonstrate the durability of the effects of 
GED devices in reducing or eliminating SIB and AB. However, this 
evidence lacks key information and provides only weak support for the 
durable effectiveness of ESDs. Importantly, the ESDs were part of 
multi-element interventions and thus were not solely responsible, if at 
all, for any long-term changes in individuals' behavior. As section 
II.C.1 explains, multi-element treatment plans that do not involve the 
use of ESDs can be expected to result in durable effects (e.g., Ref. 
97).
    Although JRC claims on its Web site that its devices are 100 
percent effective (Ref. 98), at the Panel meeting JRC's Director of 
Research acknowledged, ``The GED and skin shock is not 100% effective 
for everybody . . . there are cases in the literature that show that 
some people it doesn't work for.'' He acknowledged that sometimes 
patients adapt to ESD shocks:

    [O]ne of the things that happens sometimes when you use these 
types of devices is that there's a phenomenon of adaptation, which 
means that the skin shock device no longer functions as a punisher 
and the behaviors return. And that comes from using it over and over 
again, and the frequency of the behaviors accelerates and it no 
longer functions as a punisher, it no longer controls the behaviors. 
So when that happens, then you move--one of the things you can do is 
move to higher levels of stimulation . . . [W]hat JRC found in the 
'90s was that if you start off at a level of 15, then you're less 
likely to encounter that adaptation. And then we've also found that, 
in the rare cases where there is adaptation to the GED, we can move 
to the GED-4 and we generally don't see adaptation at all after 
that.

He later stated that JRC has ``even seen adaptation to [the GED-4] in a 
few cases, and we've had to put in special protocols to help those 
particular people,'' which include ``a very comprehensive alternative 
behavior program'' that has been ``very effective'' for at least one 
individual.
6. Information From Patients and Their Family Members
    At the Panel Meeting, a member of a JRC parent association 
explained that her child's treatments were not successful until they 
tried JRC's GED device. The speaker thought that the skin shock quickly 
and effectively targeted specific behaviors while other treatments did 
not stop dangerous or self-abusive actions. The three individuals 
formerly at JRC who expressed their opposition to a ban at the Panel 
Meeting described their severe behavior issues and the failures of 
alternative treatments. They described successful outcomes after 
application of GED devices at JRC, and they described how they are now 
independent, well-

[[Page 24403]]

functioning members of society and, in one case, married with children. 
The family members of individuals at JRC who opposed a ban described 
the serious SIB and AB that the individuals exhibited and the various 
treatments that they tried and that failed (pharmacological treatments, 
physical restraints, and positive behavioral interventions) prior to 
application of a GED device at JRC. They stated that as a result of GED 
application, their family members have exhibited less SIB and AB, are 
happier, and are improving their lives.
    One of the parents' associations submitted a comment that included 
32 letters from family members of individuals at JRC reporting success 
stories for the GED devices. One letter includes seven case reports of 
individuals said to have been successfully treated at JRC with ESDs. 
The letters contend ESDs were the only successful treatment for their 
family members. They describe the individuals' severe behaviors prior 
to GED use, some life-threatening, including eye-gouging, suicidality, 
depression, swallowing sharp objects, cutting wrists, biting 
themselves, head-banging, hitting themselves with hard objects, running 
into walls, jumping out of windows, scrotal tearing, rumination, and 
projectile vomiting. The family members describe how previous 
treatments failed, leading many schools to reject or expel the 
individuals; in contrast, they described successful treatment with ESDs 
at JRC.
7. Information From Other Stakeholders
    One speaker at the Panel Meeting, who described himself as a doctor 
who worked in the field for over 25 years, said that he had published 
peer-reviewed articles on both positive behavior support and punishment 
technologies. He opposes a ban ``in the spirit of the right to 
effective treatment.'' He believes that for some individuals, ``primary 
salient punishment is what's necessary in order to compete with their 
repertoires.''
    Several of the written comments we received from disability rights 
advocates assert that ESDs provide little if any benefit, and they 
criticize the scientific integrity of some of the sources cited by JRC 
in support of effectiveness. One comment from an advocate concludes 
that ``the existing literature demonstrates only that electric shock 
aversives have inconsistent short-term efficacy with absolutely no 
long-term efficacy in reducing or eliminating destructive and self-
injurious behaviors.'' The comment criticizes the evidence relied upon 
by JRC to support effectiveness as ``published internally with the sole 
involvement of their own personnel or those closely connected to their 
facility with no meaningful external review.'' For example, the comment 
states that JRC's Web site represents a self-published followup study 
on 65 individuals at JRC as data-based research, yet no related paper 
was accepted for peer review and there is no explanation or context for 
the methods of data collection.
8. Conclusion
    Our search of the scientific literature regarding the effect of 
ESDs on SIB and AB revealed a number of studies showing that ESDs 
result in the immediate interruption of the target behavior upon shock, 
and some of the literature also suggested varying degrees of durable 
conditioning. However, these studies suffer from serious limitations, 
including weak study design, small size, and adherence to outdated 
standards for study conduct and reporting. Also, the conclusions of 
several of the studies are undermined by study-specific methodological 
limitations, lack of peer review, and author conflicts of interest. 
There is also evidence that the shocks are completely ineffectual for 
certain individuals. FDA has determined that the evidence shows that 
ESD shocks generally interrupt and cause immediate cessation of the 
target behavior when applied at the onset of such behavior, but the 
evidence is otherwise inconclusive and does not establish that ESDs 
improve the underlying condition or successfully condition individuals 
to achieve durable long-term reduction of SIB or AB.

C. State of the Art

    FDA considers the reasonableness of the risks of ESDs relative to 
the state of the art, i.e., the current state of technical and 
scientific knowledge and medical practice (see 44 FR 29214; May 18, 
1979).
1. Scientific Literature
    In our systematic review of the scientific literature, FDA found 
that the weight of the evidence indicates the state of the art for the 
treatment of SIB or AB relies on multi-element positive methods, 
especially positive behavioral support (PBS), sometimes in conjunction 
with pharmacological treatments, and has evolved away from the use of 
ESDs. The first published studies of contingent skin shock (the 
stimulus delivered by an ESD) took place in the 1960s (see Ref. 3, 
summarizing published research). Since then, advances in science and 
medicine have led to a better understanding of the environmental 
triggers and organic origins of SIB and AB, improved behavior analysis 
methodology, and heightened ethical and human rights concerns regarding 
the use of ESDs, particularly in vulnerable patient populations (e.g., 
Refs. 99 and 100). We found that the state of the art has progressed 
along with these advancements, which have led to treatments that are 
successful in treating SIB and AB, and hold greater promise for 
achieving long-term results, while avoiding the risks posed by ESDs.
    a. Multi-element positive interventions. Elements, sometimes called 
components, of multi-element positive methods such as PBS, span several 
categories for a wide variety of purposes (e.g., Refs. 101 and 102). 
The term ``positive'' can apply to many different treatment modalities, 
such as educative programming, functional communication training, and 
non-aversive behavior management, but it does not include aversive 
interventions such as contingent skin shock (Refs. 103 and 104).
    Positive-intervention treatments incorporate the scientific and 
medical developments of recent decades as their foundation. For 
example, researchers have learned that behavioral treatment strategies 
should account for emotions and self-invalidation (rejecting the 
validity of one's own thoughts or emotions), which can be underlying 
factors associated with challenging behaviors (e.g., Ref. 105). 
Relative to approaches in previous decades, multi-element positive 
interventions broaden the scope for treatment of SIB or AB to include 
such factors. Pharmacotherapy (the use of medications) has similarly 
evolved in terms of understanding the relationship between underlying 
factors and SIB or AB (discussed in more detail in this section). In 
essence, medical approaches now treat SIB and AB as results of 
environmental cues and biological processes rather than subdue them 
through punishment-based techniques (Refs. 99 and 106).
    The key to creating a plan to address these cues and processes was 
the development of a formalized analysis, called a functional 
behavioral assessment (Ref. 106). Such an assessment is an analytical 
tool that facilitates various methods of applied behavioral analysis 
(ABA), which tailors treatment to the specific patient, particularly 
with respect to preventive measures. ABA is a fairly large family of 
treatment models that has existed as a general category for several 
decades. Although different authors define its scope differently, and 
older ABA models included aversives, in reviewing

[[Page 24404]]

the state of the art, we have focused on behavioral treatment models 
descended from ABA that are based on current scientific and medical 
research. Overall, ABA and its progeny treatment models have led the 
treatment of SIB and AB beyond ESDs toward multi-element positive 
interventions, sometimes alongside pharmacotherapy, designed for the 
individual patient (Refs. 97, 99, and 106).
    To design the intervention, clinicians first conduct a 
comprehensive functional behavioral assessment to identify the target 
behaviors and the environmental and social triggers that contribute to 
them. This includes identifying the frequency of the unwanted behaviors 
as well as the social context and other environmental conditions (e.g., 
loud noise, crowded room) in which the behaviors are more likely to 
occur (e.g., Ref. 106 discussing ``environmental redesign''). Failure 
to conduct a functional behavioral assessment may actually lead to harm 
because the resulting plan may inadvertently reinforce and consequently 
increase the problem behavior (Ref. 107). Following the functional 
behavioral assessment, a behavioral treatment plan is developed 
utilizing a positive behavioral therapy approach, such as those 
discussed in the paragraphs that follow. Clinicians would ordinarily 
try multiple treatment interventions if the initial treatment is not 
successful.
    One particular type of positive behavioral therapy discussed in the 
literature is PBS. PBS uses functional behavioral assessment to develop 
a treatment strategy geared toward teaching new behaviors (Refs. 59, 
99, and 108). These new behaviors proactively displace undesirable 
behaviors such as SIB and AB by teaching patients to express themselves 
with behavioral substitutions that will not cause harm to themselves or 
others. Functional communication training is one such approach. This 
process examines the communicative intent of the problem behaviors 
(what the individual is trying to tell or obtain from others), and then 
focuses on teaching the individual a functionally equivalent, but non-
problematic, behavior (Ref. 107; see also Ref. 104). Several studies 
have demonstrated the value of functional communication training, 
especially when included as part of a comprehensive, multi-element 
intervention such as PBS (see Ref. 109 for a review of 29 studies).
    PBS also relies on reinforcing desired behaviors, altering the 
environment to prevent or avoid triggers, and is explicitly 
nonpunitive. Thus, PBS treatments exclude physical aversive 
conditioning techniques, which react to self-injurious or aggressive 
behavior rather than prevent such behavior from occurring in the first 
place, and can often lead to the escalation of the same events they are 
trying to prevent (Refs. 97, 99, and 101). Although proactive in 
nature, PBS plans may include rapid-reaction strategies for potentially 
serious problem behaviors that might pose a risk of harm to the subject 
or others to reduce the severity of an episode of problem behavior 
(Ref. 97). In contrast to a punishment technique, such plans are not 
intended to condition the individual or provide behavioral 
reinforcement.
    Another more recently developed positive-based behavioral therapy 
for SIB and AB is dialectical behavioral therapy (DBT). Like PBS, DBT 
grew out of ABA principles (Ref. 105). DBT is a cognitive behavioral 
treatment that was originally developed to treat chronically suicidal 
individuals diagnosed with borderline personality disorder, and it is 
now recognized as a standard psychological treatment for this 
population (Ref. 110). Research has shown that it is also successful in 
treating a wide range of other disorders such as substance dependence, 
depression, PTSD, and eating disorders.
    DBT consists of four components: A skills training group, 
individual treatment, DBT phone coaching, and a DBT therapist 
consultation team. Similar to PBS, DBT is a multi-element, empirical 
approach to treatment that relies on a behavioral analysis and 
emphasizes empathy, acceptance, and collaboration (Refs. 105 and 111). 
In both therapies, the goal is to impart new skills such as 
mindfulness, distress tolerance, interpersonal effectiveness, and 
emotion regulation (Refs. 105 and 111). However, because DBT was 
developed to treat certain conditions that may give rise to SIB and AB, 
such as borderline personality disorder, it differs subtly from PBS and 
centers on treating emotional dysregulation (Refs. 105 and 111). Thus, 
even though two patients may manifest SIB, DBT may be suited to treat 
one more than the other, depending on the underlying condition (Ref. 
105).
    b. Evolution of the state of the art away from ESDs and toward 
positive interventions. During the 1960s and 1970s, aversive 
conditioning procedures were often used because they potentially 
offered a relatively easy way to immediately, if only temporarily, stop 
problem behaviors such as SIB or AB (Ref. 112). In one study of 
contingent skin shock, the authors observed that patients in treatment 
wards exhibiting such behaviors often went untreated because of 
staffing inadequacies, including lack of training in reinforcement 
techniques (Ref. 36). In an overwhelmed ward, contingent shock 
potentially offered a quick fix (Ref. 36). The authors noted, however, 
that to get such results, they chose ``a strong shock which guaranteed 
quick suppression,'' one they felt was ``definitely painful'' (Ref. 
36).
    Despite the apparent convenience, researchers have long raised 
ethical concerns about purposefully subjecting patients to the harms 
caused by physically aversive stimuli (Refs. 36 and 103). Patients 
subject to ESDs ``gave every sign of fear and apprehension'' associated 
with pain and anxiety (Ref. 36), yet decades ago, there was little 
oversight by human rights or behavior committees (Ref. 112). Indeed, 
experiments in punishment contributed to the development of behavior 
committees, and eventually the modern institutional review boards that 
are now mandatory for human research. As discussed in section II.A.1, 
patients may adapt to a particular shock level, which may lead to 
stronger shocks, thereby escalating ethical concerns (Ref. 59). Given 
the ethical implications, experts were cautioning as early as 1990 
against allowing a crisis intervention procedure to turn into a 
continuous management technique (Ref. 103).
    Whereas ethical and human rights concerns related to the risks 
posed by aversive techniques, especially ESDs, were drivers of the 
movement in the medical community away from these techniques (Refs. 106 
and 112), the rise of positive behavioral interventions appears to be 
attributable to their success in treating problem behaviors while 
posing little to no risk. The literature supports a finding that newer, 
positive treatment approaches that are not combined with any aversive 
techniques are equally successful as approaches that use both positive 
and aversive techniques, regardless of the problem behavior targeted 
(Ref. 113). Indeed, providers and researchers have found that PBS is 
successful in the treatment of even the most challenging behaviors 
(Refs. 97 and 101), including in community and home settings (Refs. 95, 
114, and 115). A review of 12 outcome studies for multi-element 
positive interventions, for a total of 423 patients, also concluded 
that PBS appears to be successful for the most challenging behaviors 
(Ref. 97). Similarly, randomized controlled trials have demonstrated 
that DBT successfully reduces self-injury in patients with borderline 
personality

[[Page 24405]]

disorder and adolescents with SIB (Refs. 111, 116, and 117).
    PBS is also more adaptable than aversive conditioning techniques 
because it can achieve durable results for patients for whom aversive 
conditioning cannot. In particular, a consequential strategy such as 
aversive conditioning cannot achieve behavioral conditioning for some 
patients who have conditions that impair their ability to understand 
consequences and react by changing their behaviors. For example, a 
patient exhibiting SIB or AB may have severely impaired short-term 
memory and impulse control such that that any consequential strategy 
(like ESD shocks delivered in consequence of exhibiting a target 
behavior) may be limited in what it can accomplish (Ref. 97). Since PBS 
relies on preemptively identifying and reducing the problem behaviors' 
triggers, proactively reducing the problem behavior and not reactively 
relying on consequences, it has an inherent advantage over aversive 
conditioning techniques for such patients (Ref. 97).
    The adaptability of PBS is also intentional, resulting from 
providers' efforts to translate positive treatment outcomes that were 
demonstrated in clinical settings (inpatient treatment facilities) to 
community settings (Refs. 99 and 106). The relatively little basic 
clinical research on contingent shocks (shocks given in response to 
certain behaviors), such as those applied by an ESD, is difficult to 
translate into treatment plans because aversive conditioning-based 
techniques, including the application of ESDs, are context-sensitive 
and may not remain effectual in different physical environments, from 
different providers, or for different patients (Refs. 36, 44, 59, and 
93). Further, as discussed in section II.B.2, the available evidence 
does not demonstrate that aversive conditioning-based techniques 
provide durable long-term effectiveness (Refs. 34, 36, 59, and 95). In 
contrast to continual application of physical aversive conditioning 
techniques to suppress problem behaviors, PBS can achieve durable, 
successful treatment in community and home settings by targeting the 
underlying causes of the behavior and imparting the skills needed to 
address it (Refs. 99 and 106).
    Like PBS, DBT is adaptable and has been shown to be successful in 
individuals with intellectual disabilities, in particular in reducing 
the severe SIB or AB of such individuals (Ref. 105). DBT also appears 
to achieve durable results after in-patient treatment (Ref. 117), and 
recent research suggests that, for some people, DBT approaches can 
effectively treat SIB on an outpatient basis (Ref. 116).
    The only risk FDA found to be associated with positive behavioral 
treatments is one posed by ``extinction,'' a common, integral component 
of behavioral plans (Refs. 118 and 119). An extinction process reduces 
a target behavior by withholding the reinforcer, i.e., the response 
sought with the target behavior (e.g., Ref. 120). Extinction exhibits 
the potential risk of ``extinction bursts,'' an upsurge of the actual 
undesirable behavior, particularly manifested in the early stages of 
the intervention. If this upsurge in behavior poses a danger to the 
individual or others, then an extinction paradigm may not be a feasible 
option (Ref. 120). In general, however, positive behavioral therapies 
pose little to no risk to patients.
    Not all treatment providers follow a positive-only behavioral 
treatment model such as PBS (Refs. 113 and 115). As explained in 
section II.B.1, FDA's review of the available data and information did 
reveal that aversive conditioning techniques may provide some effect of 
immediate cessation (e.g., Ref. 59), especially when paired with 
positive approaches (e.g., Ref. 113). As such, providers may believe 
that aversive conditioning techniques offer a viable option of last 
resort (Refs. 36, 99, and 112). However, the literature contains 
reports that when health care providers have resorted to punishers, the 
method was usually no more intrusive than water mist, and the addition 
of punishers proved no more successful than PBS-only techniques (Refs. 
99 and 113). Reflecting this trend, a 2008 survey of members of the 
Association for Behavior Analysis found that providers generally view 
punishment procedures as having more negative side effects and being 
less successful than reinforcement procedures (Ref. 115).
    The comments submitted by JRC question the effectiveness of 
positive behavioral interventions, citing three case review studies of 
``positive-only'' approaches covering successive time periods. In JRC's 
characterization, a study covering 1969 to 1988 found a success rate of 
37 percent for such an approach (Ref. 121), one covering 1985 to 1996 
found a 52 percent success rate (Ref. 99), and the third, covering 1996 
to 2000, found a 60 percent success rate (Ref. 122). JRC also cites a 
literature review to support its claim that positive-only interventions 
sometimes require supplementation with punishment techniques (Ref. 
123).
    These studies do not alter FDA's conclusions regarding the 
effectiveness of positive behavioral interventions or the state of the 
art for the treatment of SIB and AB. We note that the first review 
cited by JRC (Ref. 121) includes comparative assessments of positive-
only approaches showing that, for the category of behaviors referred to 
by JRC (positive-only approaches targeting SIB), skills acquisition and 
stimulus-based interventions had 50 and 52 percent success rates, 
respectively, during the reviewed time period. FDA recognizes that 
positive behavioral interventions may not always be successful on their 
own for all problem behaviors in all patients. However, we note the 
substantial progress in non-aversive approaches for the treatment of 
SIB and AB as providers have gained experience with them over time, 
which is evident in the increasing success rates cited in JRC's 
comment.
    Further, one review cited by JRC (Ref. 123) studied the addition of 
punishment procedures generally and did not address the use of ESDs in 
particular. Punishment procedures can take a wide variety of forms in 
addition to ESDs, such as daily point deductions, verbal reprimands, or 
food deprivation. Although the authors concluded that aversives 
appeared to improve some patients' outcomes, they did not conclude ESDs 
were a necessary aversive, and the intervening years have yielded even 
more favorable results for positive-only approaches (Ref. 97).
    Review of the current scientific literature confirms that, in 
recent decades, medical practice has shifted away from restrictive 
physical aversive conditioning techniques such as ESDs and toward 
treating patients with SIB and AB with positive-based behavioral 
interventions (Ref. 113). PBS emerged beginning in the 1980s (Refs. 97, 
106, and 112), and continued to develop in the ensuing years, 
emphasizing empirical analysis and applicability to non-clinical 
settings (Ref. 106). One analysis showed that, beginning in the 1990s, 
the use of positive techniques increased while the use of punishment 
techniques, which include physical aversives, dropped (Ref. 124). A 
survey of experts in the related fields of PBS and ABA found that the 
largest dropoff in usage of punishment techniques occurred between the 
1980s and 1990s (Ref. 112). Such surveys show the ABA field as a whole 
moved away from intrusive physical aversive conditioning techniques 
such as ESDs 2 decades ago (Refs. 103 (reprinted from 1990) and 112).
    Correspondingly, many authors have noted that research of 
punishment-based techniques--which includes a broad range of 
consequences, from the

[[Page 24406]]

application of ESDs, to food deprivation, down to deducting daily 
points--has dwindled for decades (Refs. 59, 93, and 115). Most of the 
papers written since 2000 on the use of ESDs are by JRC employees and 
JRC consultants (Ref. 98), which raises questions regarding their 
impartiality, as discussed earlier in section II.B.2. Although the 
anecdotal reports in two of JRC's self-authored papers purport to 
provide evidence of persons refractory (resistant) to all behavioral 
controls except ESDs (Refs. 30 and 94), these findings were not 
published in a peer-reviewed journal, and they suffer from a number of 
methodological shortcomings that raise questions about their validity, 
as discussed earlier in section II.B.2. In direct contrast, one study 
that followed up on adults on whom ESDs were used in an unnamed 
residential facility in the northeast United States (most likely JRC) 
found that less restrictive interventions successfully treated SIB and 
AB after ESDs were removed (Ref. 95).
    c. Use of pharmacotherapy to treat SIB and AB. In current medical 
practice, the treatment of SIB and AB with positive behavioral 
interventions (e.g., PBS or DBT) is sometimes supplemented with 
pharmacotherapy. Drugs that act in the brain may provide clinical 
benefit, although the biochemical pathways that may contribute to SIB 
and AB are not well understood.
    SIB and AB are seen in patients with a variety of diagnoses, 
including autistic disorder, Fragile X syndrome, Lesch-Nyhan syndrome, 
and other developmental disorders. There are currently two drugs that 
have been approved by FDA for the treatment of irritability associated 
with autistic disorder in children, a population representing a small 
subset of all patients with SIB and AB. RISPERDAL (risperidone) was 
approved in 2006 for the treatment of irritability associated with 
autistic disorder based on clinical trials in patients ages 5 to 17 
years old, and ABILIFY (aripiprazole) was approved in 2009 for the same 
indication based on clinical trials in patients ages 6 to 17 years old. 
In the trials conducted for approval, SIB and AB were among the 
emotional and behavioral symptoms of autism that were measured in the 
overall evaluation of irritability.
    The most common adverse reactions observed in the trials conducted 
for approval of these two drugs were sedation, increased appetite, 
fatigue, constipation, vomiting, and drooling. Other serious adverse 
reactions with the use of these drugs may include neuroleptic malignant 
syndrome, tardive dyskinesia, and metabolic changes.
    Published literature describes the clinical use of pharmacotherapy 
for the treatment of SIB and AB, which includes the use of atypical 
antipsychotics such as risperidone and aripiprazole as well as drugs 
from other pharmacological classes. (See Ref. 3 for a review of 
relevant literature examining the use of pharmacotherapeutic 
interventions in the treatment of SIB and AB.) Reports describing the 
use of certain atypical antipsychotic drugs (e.g., risperidone and 
aripiprazole) are the most common, which may be in part because safety 
data on their use in pediatric patients are already available and 
because two of them (risperidone and aripiprazole) have been approved 
by FDA for use in the subset of patients with SIB and AB who have 
irritability associated with autistic disorder.
2. Information and Opinions From Experts
    FDA asked the Panel whether treatment options other than ESDs, 
including behavioral, pharmacological, alternative, and experimental 
therapies, are adequate to address SIB or AB. Most of the Panel opined 
that other treatments are not adequate for all individuals who exhibit 
SIB or AB, citing a lack of sufficient data demonstrating efficacy, 
especially when evaluating the durability of benefits, drug side 
effects, and that ``it's unfortunately rare that any treatments in 
psychiatric or behavioral issues are universally effective.'' FDA also 
asked the Panel whether a specific subpopulation of patients exhibiting 
SIB or AB exists for whom pharmacological and behavioral treatment 
options other than ESDs are inadequate. The panel unanimously concluded 
that such a subpopulation seems to exist but is very difficult to 
define and recommended additional research into refractory 
subpopulations.
    Based on the available data and information, FDA is not aware of 
any recognized clinical criteria to identify refractory patients. We 
could not find rigorous or systematically collected data that 
distinguish a refractory subpopulation that does not respond to other 
available treatments. Even assuming a subpopulation exists for which 
treatments other than ESDs are not adequately effective, that does not 
mean ESDs are effective for that subpopulation. As with other 
psychological or neurological conditions, there may simply be a 
subpopulation of patients for whom there is no adequate treatment 
option. As discussed previously, although some evidence suggests ESDs 
reduce SIB and AB in some patients, no randomized controlled clinical 
trials have been conducted to demonstrate effectiveness generally or 
that ESDs are effective for behavioral conditioning when other options 
fail.
    Accordingly, the Agency agrees with the observation made by one of 
the Panel experts: Although other treatments may not completely reduce 
or eliminate SIB or AB in all patients, that does not mean ESDs should 
be used. In determining whether to ban these devices, FDA balances 
effectiveness against the risks they pose and assesses the 
reasonableness of such risks in light of the state of the art. The 
state of the art is to use positive behavioral interventions, sometimes 
in conjunction with pharmacotherapy, even for the most challenging SIB 
and AB; the unsubstantiated claim that ESDs are uniquely effective for 
refractory individuals does not alter that conclusion. As the Panel 
expert cited previously explained, ``the statements of professional 
programs and the fact of wholesale abandonment of aversive electrical 
shock therapy by the peers in this field show that it is unreasonable 
to conclude that these devices are part of the standard of care for 
this class of patients . . . ''.
    Epitomizing the decades-long shift away from ESDs, one of the 
device's pioneers has publicly repudiated contingent shock for its lack 
of effectiveness (see Ref. 125). Another expert summarized in an 
interview that the modern clinical approach is the result of science 
establishing better methods, compared to ESDs, for the treatment of 
severe problem behaviors (see Ref. 126), and another expert repudiated 
behavioral treatments that use punishment techniques more broadly as 
early as 1989 (see Ref. 107 for a summary).\4\
---------------------------------------------------------------------------

    \4\ Sidman, M., Coercion and Its Fallout. Authors Cooperative: 
1989.
---------------------------------------------------------------------------

    FDA also considered information and opinions on state-of-the-art 
treatment for SIB and AB in the expert reports it obtained. Dr. Smith's 
opinion notes similar trends that FDA has identified regarding the 
development of positive interventions for SIB and AB based on a 
functional behavioral assessment, which allows the customization of a 
treatment plan to meet the individual's needs. In his view, the data do 
not support a precise estimate for success rates of positive 
interventions in patients exhibiting SIB or AB, but he notes the rapid 
increase in reported effectiveness, from a 1990 review that

[[Page 24407]]

found a success rate of 50 percent to a recent unpublished result of 84 
percent. Dr. Smith concludes that non-aversive interventions can be 
effective for most, but not all, people with intellectual or 
developmental disabilities, which is true of any such treatment (Ref. 
8).
    Dr. Brown's report provides additional detail on the development of 
the PBS field. She believes 20 years of empirical evidence demonstrate 
that plans designed around a functional behavioral assessment can 
effectively address even the most serious problem behaviors. She 
contrasts this evidence base with that for contingent skin shock, for 
which she identifies a sharp decline beginning in the 1990s. In her 
view, dated research on contingent skin shock is not particularly 
relevant to current perspectives on people with disabilities, 
especially given that such research does not meet modern standards for 
study conduct or comport with the current medical understanding of 
serious psychological disorders.
    One of the developments that Dr. Brown highlights is the 
understanding that the ``[r]eduction of problem behavior is an 
important, but not the sole, outcome of successful interventions'' 
(Ref. 107). Instead, an effective PBS intervention will enhance quality 
of life, acquisition of valued skills, and access to valued activities 
(Ref. 107; see also Refs. 127-129).
    Dr. Brown also contrasted the amount and availability of 
publication and training between PBS and contingent skin shock. In 
particular, several books and peer-reviewed journals focus specifically 
on PBS, and graduate training programs and organizations foster the 
competent development and implementation of PBS. In contrast, to her 
knowledge, ``no journals, books, graduate programs, or organizations 
focus [ ] on the skills necessary to use contingent electric shock or 
other aversive interventions'' (Ref. 107).
    Dr. Brown further points out that while no professional 
organization publishes standards of practices for the use of ESDs, the 
Association for Positive Behavior Supports has adopted standards of 
practice for the elements that comprise PBS (Ref. 107).\5\ To meet the 
current standards of practice, a PBS plan must: (1) Address the 
communicative intent of the problem behavior, e.g., with functional 
communication training; (2) identify and implement curricular and 
environmental modifications; and (3) focus on the patient's choice and 
control. In Dr. Brown's opinion, ``professionals who are willing to use 
[contingent electric shock] are likely those that do not have any 
expertise in the use of PBS'' and so would not have previously 
implemented plans that meet the standards of practice, reducing their 
likelihood of success (see also Ref. 101).
---------------------------------------------------------------------------

    \5\ Association for Positive Behavior Supports, Positive 
Behavior Support Standards of Practice: Individual Level, 2007, 
available at http://apbs.org/standards-of-practice.html.
---------------------------------------------------------------------------

    Similar to Dr. Brown's conclusions, Dr. LaVigna's expert report 
also emphasizes that a positive-only treatment plan developed according 
to specific guidelines will adequately address even the most 
challenging behaviors, regardless of the individual's diagnosis or 
functioning level (Ref. 130). He separates possible elements of a PBS 
plan into four categories: (1) Ecological strategies, which address a 
mismatch between the individual's needs and the environment; (2) 
positive programming strategies, which teach new skills with specific 
instructional methods; (3) focused support strategies, which reduce or 
eliminate the behavior primarily through antecedent control; and (4) 
reactive strategies, which, unlike a punishment-based method, are 
intended only to reduce the immediate behavior (Ref. 130).
    Dr. LaVigna elaborates on the relatively recent development of a 
new outcome measure and principles to define challenging behaviors, 
including episodic severity as well as the principles of resolution and 
escalation (Ref. 130). Episodic severity allows a provider to account 
for more than the frequency of the target behavior by adding data about 
how severe the particular occurrence was (Ref. 130). In this way, 
progress can be measured more completely by including a reduction in 
severity, rather than merely looking at the number of occurrences. The 
principles of resolution and escalation allow a provider to categorize 
outcomes of interventions, which means they ``can explicitly take 
responsibility'' for strategies to achieve reductions in episodic 
severity (resolution) rather than increases in severity (escalation) 
(Ref. 130).
    With the advent of PBS, along with refinements such as improved 
outcome measures and definitions, Dr. LaVigna points to recent 
literature that studied over 500 patients and found that PBS was 
effective (Ref. 130). He also recounts an example of a patient for whom 
ESDs had been recommended, observing that correctly implemented 
positive-only methods were able to treat the patient instead (Ref. 
130). He asserts that, not only is PBS highly effective even for the 
most challenging behaviors, but that it can be implemented in community 
and institutional settings cost effectively and accessibly (Ref. 130). 
He concludes that ``[p]unishment is unnecessary, and is not the 
accepted standard of care in the relevant treatment community'' (Ref. 
130).
    The limited and generally outdated evidence base supporting the use 
of ESDs contrasts markedly with the extensive, current, and growing 
evidence base for PBS. While ESD use is founded upon research that 
incorporates outmoded assumptions and in practice has often sought 
compliance with staff-determined norms rather than focusing on 
clinically relevant behaviors, PBS reflects modern medical advancements 
and emphasizes patient choice, participation, and skills acquisition, 
even for patients with the most challenging behaviors. PBS enjoys 
thriving academic support and PBS practitioners can refer to practice 
guidelines published by a professional organization, while academic 
interest in aversive conditioning has languished and the use of ESDs is 
not contemplated in a comparable publication.
3. Information From State Agencies and State Actions on ESDs
    FDA considered the actions of States with respect to ESDs and 
aversive interventions generally, and we found that many already 
prohibit the use of these devices. In 2011, the Massachusetts 
Department of Developmental Services (DDS) proposed regulations to 
prohibit the use of contingent skin shock on individuals other than 
those who have an existing court-approved treatment plan that includes 
the use of such devices as of September 1, 2011.\6\ According to the 
Massachusetts DDS response to comments on its proposed regulation, 20 
States as well as the District of Columbia specifically prohibit 
aversive interventions (Ref. 131). Massachusetts' finalization of its 
regulations brings the number up to 22 jurisdictions. According to a 
comment from NASDDDS on the 2014 Panel Meeting, 40 States and the 
District of Columbia ``have adopted regulations or policies that 
expressly prohibit the use of interventions that cause pain, are 
humiliating, and violate human rights.''
---------------------------------------------------------------------------

    \6\ Massachusetts DDS specifically addressed comments that 
sought an extension of the prohibition to patients with court-
approved treatment plans that include the use of ESDs. However, 
noting the many guardians and family members of individuals 
receiving treatment with ESDs believe this is the only form of 
effective treatment for their loved ones, DDS expressed a desire not 
to repeat the history of extensive litigation over access to these 
devices (Ref. 131).
---------------------------------------------------------------------------

    These State laws prohibiting or restricting the use of ESDs provide 
further support that these devices are

[[Page 24408]]

not part of the state-of-the-art treatment for SIB or AB. The fact that 
only one site in the United States uses ESDs on individuals with SIB or 
AB (Ref. 73), and that the individuals subject to ESDs are 
predominantly from two States, and from fewer than a dozen in total,\7\ 
strongly suggest the overwhelming majority of patients exhibiting SIB 
and AB throughout the country are being treated with methods that do 
not involve ESDs. Given that, as discussed in section I.B, at least 
330,000 individuals in the United States exhibit SIB or AB, JRC (with 
fewer than 300 residents) observes a very tiny fraction of all such 
individuals.
---------------------------------------------------------------------------

    \7\ Although JRC stated at the Panel Meeting that it serves 
patients from 11 States, according to one of JRC's comments, the 82 
patients on whom GED devices had been used as of April 2014 are from 
only 6 States, and 60 of them are from either New York or 
Massachusetts (Ref. 21).
---------------------------------------------------------------------------

    In fact, the Massachusetts DDS has successfully transitioned 
several patients who were subject to ESDs at JRC to providers who do 
not use ESDs (Ref. 132; see also Ref. 95). FDA agrees with the 
assessment of the current standard of care by the Massachusetts DDS:

    The Department concludes that there has been an evolution in the 
treatment of severe behavioral disturbances in persons with 
intellectual disability over the past thirty years, and particularly 
in the last two decades, which has moved towards forms of treatment 
that are non-aversive and involve positive behavioral supports.
    The Department bases this opinion both on the body of empirical 
evidence showing the effectiveness of other less intrusive forms of 
treatment that do not involve pain; on the overwhelming support of 
this position by virtually every local, statewide or national 
organization supporting individuals with intellectual disability, 
and by providers and clinicians whose practice demonstrates that 
non-aversive treatment can modify difficult or dangerous behaviors 
effectively and for the long-term, while aversive interventions, in 
addition to causing pain and anxiety in such individuals, have no 
proven long-term efficacy.

(Ref. 131; see also Ref. 132.)

    Evidence from other States further corroborates our conclusions. 
For example, as discussed earlier, according to NYSED, following 
promulgation of regulations in 2006 by NYSED prohibiting future 
introduction of ESDs in public and private schools and requiring review 
of students then subject to ESDs, independent panels of behavior 
experts determined that ESDs were not warranted in almost every 
instance over a 6-year period. Similarly, at the Panel Meeting, the 
Assistant Attorney General for the State of Utah, representing his 
State's agencies that provide services and protection for individuals 
with disabilities, observed that programs in Utah and across the nation 
effectively treat SIB and AB without ESDs.
4. Comments From the Affected Manufacturer
    At the Panel Meeting, the presenters for the manufacturer stated 
that the data demonstrate a clear clinical need for these devices. In 
their view, therapy for these individuals has failed at all other 
treatment centers, and other treatments have failed at JRC prior to the 
utilization of their GED devices. They asserted that a wide range of 
therapeutic interventions over long periods of time have been 
ineffective for their residents on GED devices, and that typically 12 
to 15 other facilities have expelled or rejected these residents before 
they come to JRC. They stated that the individuals on whom ESDs are 
used are those with extraordinary behavior disorders. JRC's position is 
that few other treatment facilities, if any, will accept patients who 
have not improved without aversives, and that the only other options 
besides ESDs would be psychotropic drugs and various restraints (Ref. 
21).
    FDA has found no basis to believe that the patients on whom ESDs 
are used at JRC are patients with the most severe SIB and AB in the 
United States. FDA also has reason to doubt whether all alternatives 
were adequately attempted before resorting to ESDs. As noted in section 
II.C.5, we are aware that some parents have reported that JRC did not 
attempt positive approaches based on functional behavioral assessments, 
and the parents felt pressured into accepting the necessity of ESDs 
(Ref. 133). Similar to the NYSED review discussed in sections II.A.4 
and II.B.4, another review revealed that the facility using ESDs for 
SIB and AB either did not conduct a functional behavioral assessment or 
did so in a non-standard way, which could reduce the effectiveness of 
the resulting behavioral intervention (Ref. 107). Although there is 
anecdotal evidence that treatments other than ESDs were tried on 
individuals at JRC and failed prior to use of ESDs, there is evidence 
in the literature that patients have been successfully treated with 
alternatives after ESDs were used (Ref. 95).
    Further, evidence of failures of treatments other than ESDs is not 
evidence that ESDs safely or successfully treat patients or are within 
the state of the art. To cope with patients' apparent adaptation, the 
manufacturer itself acknowledges that increasing the electric current 
may be necessary, and if that does not work, the ESD may need to be 
replaced with ``an alternative behavior program'' (Ref. 21). In fact, 
consistent with our understanding of the state of the art, JRC touts 
positive behavioral therapies, for example on the ``Unparalleled 
Positive Programing'' page on its Web site, but its Web site does not 
even mention its use of ESDs (Refs. 134 and 135).
    The comments submitted by JRC question the effectiveness of 
positive behavioral interventions based on its belief that there does 
not appear to be any clinical data supporting such, an absence of 
research concluding that ``all problem behaviors can be effectively 
treated using only PBS procedures,'' and ``literature stating that PBS 
is not always effective for self-injurious behaviors.'' The comment 
from a former JRC clinician also asserts that PBS and medications are 
not effective for all individuals with serious behavior disorders.
    Contrary to JRCs assertion, there are clinical data supporting the 
effectiveness of positive behavioral interventions such as PBS and DBT 
in treating SIB and AB, as discussed earlier in this section. Further, 
even though positive behavioral interventions may not always be 
successful on their own for all problem behaviors in all patients, this 
does not mean they are not generally effective, sometimes used in 
conjunction with pharmacotherapy, or that they are not state-of-the-art 
treatments for SIB and AB. Rather, the literature provides evidence 
showing that multi-element positive interventions are at least as 
successful as methods that include use of aversives regardless of the 
behavior targeted, as discussed earlier in this section.
    JRC also submitted a paper by Dr. Blenkush, the Director of 
Clinical Research at JRC, purporting to show that ESDs have a more 
favorable side effect profile than antipsychotic medications (Ref. 21). 
FDA notes that no peer-reviewed literature compares treatment regimens. 
Further, the JRC paper makes comparisons that may not be relevant to 
the selection of treatment for an individual. For example, the paper 
compares frequency of specific side effects from pharmacotherapy to the 
frequency of different categories of side effects from ESDs. However, 
aggregate frequency data on dissimilar effects across different patient 
populations provide scant basis for a comparison of treatment regimens. 
Comparing a comprehensive list of the side effects of several 
antipsychotic medications against the side effects of a single device, 
which the paper admits ``have not been evaluated in the same depth or

[[Page 24409]]

with as many participants'' (Ref. 21), does not represent a valid 
comparison.
    The comment from a former JRC clinician asserts the standard of 
care for treatment resistant individuals such as those at JRC includes 
consideration of aversive conditioning devices such as the GED, citing 
a textbook that discusses punishment techniques including the use of 
ESDs.\8\ FDA notes that the cited chapter reviews information on the 
SIBIS, not the GED, and except for a SIBIS case report, the chapter 
relies on pre-1990 studies. Furthermore, it concludes with the 
observation that electric shock is usually not necessary and can be 
replaced with ``more acceptable aversive outcomes'' such as a squirt of 
lemon juice or a reprimand. This evidence does not demonstrate that 
ESDs are currently considered by the scientific and medical community 
to be an acceptable option for patients exhibiting SIB and AB.
---------------------------------------------------------------------------

    \8\ Malott, R.W. and J.T. Shane, ``Punishment (Positive 
Punishment),'' in Principles of Behavior. 7th ed. 2013, Boston, MA: 
Pearson.
---------------------------------------------------------------------------

5. Comments From Patients and Family Members of Patients
    The three former JRC residents who opposed a ban at the Panel 
Meeting described their severe behavior issues and the failures of 
alternative treatments (psychotropic medications, physical restraints, 
and reward systems). One stated that the drugs made him feel like ``a 
walking zombie.'' Comments from family members of JRC residents 
similarly describe numerous failed alternative treatment attempts prior 
to finding success with ESDs at JRC. Many family members report that 
the side effects of drugs are much worse than ESDs and included: 
Extreme sedation, not recognizing or interacting with others, bizarre 
behavior, toxicity effects (such as damage to internal organs), loss of 
personality, and lack of learning. One parent listed 26 drugs her child 
had tried and other treatments that failed, including electroconvulsive 
therapy (which is different from ESD application and not the subject of 
this proposed rule). One mother noted that the behavior medications 
interacted with her child's seizure medications and caused an increase 
in seizures.
    FDA understands that family members of individuals exhibiting SIB 
or AB face very difficult choices regarding treatment options, and FDA 
does not doubt their best intentions, the sincerity of their belief 
that an ESD is the best or perhaps only option for their loved one, or 
that they have tried alternative treatments without success. However, 
FDA does have reason to question the information provided to these 
family members by JRC. One article reports that some parents who 
consented to the use of GEDs on their children did so only under 
pressure (Ref. 133). These parents reported feelings of coercion upon 
admission to the facility and intimidation when attempting to change 
their children's intervention plans (Ref. 133).\9\ The parents reported 
facing a choice between restrictive aversive strategies justified as 
measures of last resort, such as between the GED and use of a four-
point restraint board, and chose the GED as the lesser evil (Ref. 133).
---------------------------------------------------------------------------

    \9\ The authors do not identify the facility by name. However, 
they are clear that the ESD in question was the GED, refer to JRC's 
Web site, and rely on an article about JRC when characterizing the 
facility.
---------------------------------------------------------------------------

    Although the facility touts itself as accepting refractory 
patients, all of the parents interviewed provided information 
suggesting that interventions in public schools prior to JRC admission 
did not attempt all treatment options, such as using a functional 
behavioral assessment to develop prevention or antecedent strategies 
(Ref. 133). Once at JRC, none of the parents reported the development 
of prevention or antecedent strategies for their children (Ref. 133). 
Given that functional behavioral assessments, as well as prevention and 
antecedent strategies such as those in a positive multi-element 
intervention, are generally successful even for challenging SIB and AB, 
such patients may well have been responsive to PBS techniques had they 
been attempted.
    FDA acknowledges that these reports are only from certain parents 
who volunteered to share negative experiences, and we cannot conclude 
that these reported experiences were shared by others or are generally 
representative of families' experiences at JRC. Nevertheless, the 
reports do indicate that at least some parents felt pressured by JRC to 
continue to agree to the use of GEDs on their children, and for at 
least some children, alternative treatments were not exhausted. For 
them, GEDs were not in fact applied as a last resort.
6. Comments and Information From Others
    Information from other Federal agencies, behavioral psychologists, 
disability rights groups, and the United Nations corroborates FDA's 
conclusions regarding the risks of ESDs relative to the state of the 
art. For example, in its comment, the U.S. Department of Justice (DOJ) 
explained that it has concluded that ESDs are outside the generally 
accepted standard of care (Ref. 136). DOJ enforces the Civil Rights of 
Institutionalized Persons Act (42 U.S.C. 1997 et seq.), which entitles 
eligible patients to receive services that meet generally accepted 
standards of care. In order to protect that right, DOJ must determine 
relevant standards of care, giving DOJ experience in comparing 
treatment to that which providers generally accept as the standard. In 
DOJ's view, far from the standard of care, ESDs are physically and 
psychologically harmful punishments that have uncertain efficacy. 
According to DOJ, the current, generally accepted professional 
standards of care for individuals with intensive behavioral needs 
require PBS, implemented according to individualized plans, and not 
restrictive methods such as ESDs. DOJ asserts that thousands of people 
throughout the country with similar behavioral needs receive effective 
treatment without being subjected to the risks posed by ESDs.
    Behavioral psychologists who have practiced for decades treating 
patients with SIB and AB indicated in comments on the Massachusetts ban 
that they have not had to resort to aversives such as ESDs, describing 
painful aversives as ``unnecessary, unacceptable, and not supported by 
the professional literature'' (Refs. 137 and 138). Another commenter on 
the Massachusetts ban stated that in 30 years working in programs 
serving individuals with severe behavior challenges and dangerous 
behavior in more than 20 States, no program allowed use of pain to 
control behavior (Ref. 131). At the Panel Meeting, disability rights 
groups' presentations concurred that positive behavioral interventions 
have been shown to result in long-term reduction or elimination of 
challenging self-injurious or aggressive behaviors.
    Finally, the United Nations Special Rapporteur on torture and other 
cruel, inhuman, or degrading treatment or punishment, has determined 
that the application of ESDs violates the rights of individuals at JRC 
under the United Nations Convention Against Torture, as well as other 
international standards, and supports a complete ban on ``electroshock 
procedures.'' Although the United Nations is composed of many countries 
in addition to the United States, the fact that this multi-nation body 
does not merely consider ESDs to be inappropriate or unacceptable 
treatment, but considers them to constitute torture, suggests that 
there is great distance between these devices and state of the art for 
treatment of SIB and AB. Although JRC claims ESDs are used for SIB and 
AB in other

[[Page 24410]]

nations, it has not provided any examples, and FDA is unaware of one.
7. Conclusion
    FDA has determined, on the basis of all available data and 
information, that state-of-the-art treatments for SIB and AB are 
positive-based behavioral approaches, sometimes alongside 
pharmacotherapy, as appropriate, and do not include ESDs. We focused on 
data in the scientific literature, current clinical practices, and 
information about the evolution of treatments for SIB and AB.
    Significant scientific advances have yielded new insights into the 
organic causes and external triggers of SIB and AB. Although 
researchers have much yet to learn, the advent of functional behavioral 
assessment, and, subsequently, approaches like PBS and DBT, have 
allowed providers to move beyond aversive conditioning techniques such 
as the contingent shocks delivered by ESDs. The state of the art 
represents the achievements of an empirical response to the 
inadequacies of such techniques from both a safety and effectiveness 
standpoint. The scientific community has long recognized that 
addressing the underlying causes of SIB or AB, rather than suppressing 
it with painful shocks, not only avoids the risks posed by ESDs, but 
can achieve durable, long-term benefits.
    As a result, the use of aversive conditioning techniques overall, 
and ESDs in particular, has diminished considerably over the past 
several decades, while the use of positive behavioral methods has 
risen. The overwhelming majority of remaining providers who employ some 
type of aversive conditioning use methods that are much less intrusive 
than contingent shock. ESDs are only used at one facility in the United 
States on individuals from a small number of States; almost half of the 
States have specifically prohibited their use. Practitioners in the 
field with decades of experience have asserted that they have never had 
to resort to ESDs, and surveys of experts show that such views are 
common. Meanwhile, modern positive behavioral treatments have been 
demonstrated to work in complex environments like community settings 
and achieve durable results while posing very little risk (Refs. 99, 
101, and 106). Although positive behavioral interventions such as PBS 
may not always be completely successful on their own for all behaviors 
in all patients, the literature indicates that they are generally 
successful, sometimes alongside pharmacotherapy, regardless of the 
severity of the behavior targeted, and the success rates continue to 
improve.

III. Determination That ESDs for SIB and AB Present an Unreasonable and 
Substantial Risk of Illness or Injury

    As discussed in section I.F, section 516 of the FD&C Act authorizes 
FDA to ban a device intended for human use by regulation if it finds, 
on the basis of all available data and information, that such a device 
presents substantial deception or an unreasonable and substantial risk 
of illness or injury.
    In determining whether a deception or risk of illness or injury is 
``substantial,'' FDA will consider whether the risk posed by the 
continued marketing of the device, or continued marketing of the device 
as presently labeled, is important, material, or significant in 
relation to the benefit to the public health from its continued 
marketing (see Sec.  895.21(a)(1)). With respect to ``unreasonable 
risk,'' FDA analyzes the risks associated with the use of the device 
relative to the state of the art (44 FR 29214 at 29215). Thus, in 
determining whether a device presents an ``unreasonable and substantial 
risk of illness or injury,'' FDA analyzes the risks and the benefits 
the device poses to patients, comparing those risks and benefits to the 
risks and benefits posed by alternative treatments being used in 
current medical practice. Actual proof of illness or injury is not 
required; as Congress explained when it amended the medical device 
banning provisions in the FD&C Act, FDA need only find that a device 
presents an ``unreasonable and substantial risk of illness or injury'' 
on the basis of all available data and information (H. Rep. 94-853 at 
19; 44 FR 29214 at 29215).
    FDA has considered evidence from a wide variety of sources, 
including the scientific literature, experts in the field, State 
agencies that also regulate ESD use, the affected manufacturer/
residential facility, individuals on whom ESDs have been used and the 
views of their family members, disability rights groups, and other 
government entities. In weighing each piece of evidence, FDA took into 
account its quality, such as the level of scientific rigor supporting 
it, the objectivity of its source, its recency, and any limitations 
that might weaken its value. Thus, for example, we generally gave much 
more weight to the results of a study reported in a peer-reviewed 
journal by an objective author than we did to anecdotal evidence.
    As discussed in section II.A, the scientific literature 
demonstrates that ESDs for SIB and AB pose a number of psychological 
harms including depression, PTSD, anxiety, fear, substitution of other 
negative behaviors, worsening of underlying symptoms, and learned 
helplessness, as well as the physical risks of pain, and skin burns. 
These risks are not exclusive, and their harmful impact is magnified 
when an individual experiences two or more of them together. 
Misapplications of shocks present the same risks without any 
possibility of benefit. FDA determined that AEs have very likely been 
underreported due to various methodological limitations in the 
scientific literature as well as the impaired ability of many subjects 
to recognize and communicate AEs, which also increases the risk of harm 
to these individuals. Because of the likely underreporting of AEs in 
the literature and the fact that actual proof of harm is not required, 
FDA carefully considered the risks identified through other sources, 
which provide further support for the risks reported in the literature 
and indicate that ESDs are associated with additional risks such as 
suicidality, chronic stress, neuropathy, and injuries from falling. 
Although JRC has only publicly acknowledged the risks of pain and 
erythema, JRC's own records provide compelling evidence that aversive 
interventions such as ESDs are associated with several other risks, 
including nightmares, flashbacks of panic and rage, hypervigilance, 
insensitivity to fatigue or pain, changes in sleep patterns, loss of 
interest, difficulty concentrating, and withdrawal from usual activity.
    As discussed in section II.B, the studies reported in the 
scientific literature show that ESDs can immediately interrupt SIB or 
AB upon shock, and some studies suggest varying degrees of durable 
conditioning. However, the studies in the literature suffer from 
various limitations, such as weak study design, including failure to 
control for concomitant treatments, small size, other methodological 
limitations, lack of peer review, and author conflicts of interest. As 
a result, the evidence is inadequate to establish that ESDs improve 
individuals' underlying conditions or successfully condition 
individuals to reduce or cease the target behavior to achieve durable 
long-term reduction of the target behavior. Further, to the extent ESDs 
do cause immediate interruption for some, the evidence also suggests 
that the shocks are completely ineffective for others, regardless of 
shock strength. Regardless of whether adaptation is the correct 
characterization, even JRC has acknowledged that its strongest ESD 
sometimes becomes ineffective,

[[Page 24411]]

necessitating the use of an alternative behavior program instead of an 
ESD.
    As discussed in section II.C, FDA has determined that state-of-the-
art treatments for SIB and AB are positive-based behavioral approaches 
along with pharmacotherapy, as appropriate, and do not include ESDs. 
The medical community now broadly recognizes that addressing the 
underlying causes of SIB and AB, including environmental ones, rather 
than suppressing behaviors with shocks not only avoids the risks posed 
by ESDs, but can achieve durable, long-term benefits. As a result, 
research about and use of aversive conditioning techniques overall, and 
ESDs in particular, has diminished considerably over the past several 
decades, while research about and use of positive behavioral methods 
has increased and continues to increase. ESDs are only used at one 
facility in the United States with individuals from a small number of 
States. Almost half of the States prohibit ESD use, and there is 
evidence that the overwhelming majority of patients exhibiting SIB and 
AB throughout the country are being treated without the use of ESDs. 
Although positive behavioral interventions such as PBS may not always 
be completely successful on their own for all behaviors in all 
patients, the literature shows that they are typically successful (on 
their own or in conjunction with pharmacotherapy), regardless of the 
severity of the behavior targeted, even in community settings, and can 
achieve durable long-term results while avoiding the risks posed by 
ESDs.
    FDA has determined that the risks posed by ESDs for SIB and AB are 
important, material, or significant in relation to the benefit to the 
public health from their continued marketing. FDA recognizes that ESDs 
can cause the immediate cessation of self-injurious or aggressive 
behavior; however, the immediate effects the ESDs provide are 
outweighed by the numerous short- and long-term risks discussed earlier 
in this section. For many individuals who exhibit SIB or AB, these 
risks are magnified by their inability to adequately communicate the 
harms they experience to their health care providers. Even when 
immediate cessation is achieved, without durable conditioning the 
target behavior will recur over time and necessitate ongoing shocks to 
cause immediate cessation, magnifying the risks. If adaptation occurs, 
it would render the shocks wholly ineffective and could lead to 
stronger shocks with no effect. Thus, the degree to which the risks 
outweigh the benefits increases over time.
    FDA has also considered the risks posed by ESDs for SIB and AB 
relative to the state of the art. Decades ago, health care providers 
had a poor understanding of the causes of SIB and AB and very limited 
options to treat SIB or AB. Contingent skin shock was used even though 
the result was fleeting and continual shock administration was needed. 
Since then, state-of-the-art treatment for SIB and AB has evolved 
considerably. Today we know that careful functional assessment, which 
identifies specific unwanted or undesired behaviors, the frequency and 
severity of these behaviors, and their specific triggers, allows for 
the development of positive-based behavioral therapy that provides 
greater benefit and poses less risk than using ESDs. Although they may 
demand more health care provider training and effort than ESDs, various 
multi-element positive interventions such as PBS and DBT are now very 
much viable options for treatment of SIB and AB. These interventions 
pose little risk and, on their own or alongside pharmacological 
treatments, have been shown to be successful in treating even the most 
severe behaviors in both clinical and community settings, and to 
achieve durable long-term results.
    Several individuals have been successfully transitioned from ESDs 
at JRC to positive-based therapies elsewhere. Thus individuals 
exhibiting SIB or AB have alternative options to ESDs that pose less 
risk and provide greater benefit through durable long-term 
effectiveness in both clinical and community settings.
    Based on a careful evaluation of the risks and benefits of ESDs for 
SIB and AB and the risks and benefits of state-of-the-art treatments 
for SIB and AB, FDA has determined the risk of illness or injury posed 
by ESDs for SIB and AB to be substantial and unreasonable. A majority 
of the expert Panel also found that ESDs for SIB and AB present a 
substantial and unreasonable risk of illness or injury. The Panel 
members who opined that this standard is not met generally had concerns 
about foreclosing the possibility that new ESDs may be developed in the 
future and used in a way that can safely and effectively treat SIB and 
AB. In this regard, FDA notes that a banned device is not barred from 
clinical study under an investigational device exemption pursuant to 
section 520(g) of the FD&C Act. However, any such study must meet all 
applicable requirements, including but not limited to, those for: 
Protection of human subjects (21 CFR part 50), financial disclosure by 
clinical investigators (21 CFR part 54), approval by institutional 
review boards (21 CFR part 56), and investigational device exemptions 
(21 CFR part 812). Other panelists were reluctant to agree that the 
banning standard had been met because it could be possible to develop 
ESDs to treat SIB or AB without being noxious. In response to these 
concerns, FDA notes that devices that are not noxious are not within 
the scope of this ban.
    Other than JRC and the former JRC clinician, the only comments in 
opposition to a ban either at the Panel Meeting or through submission 
of comments to the Panel Meeting docket were from three former JRC 
residents, family members of individuals on whom ESDs were used at JRC 
(one of the parents association comments included 32 letters from 
family members), a Massachusetts State Representative, and one 
concerned citizen. As discussed earlier, FDA recognizes that family 
members of individuals now and previously on ESDs at JRC have had to 
make some very difficult decisions regarding the care of a loved one, 
and FDA does not doubt their intentions or question the sincerity of 
their belief that ESDs are the best or only option available. However, 
as discussed in section II.C.5, FDA has reason to believe at least some 
of these family members were pressured into choosing ESDs, and FDA 
questions whether these family members were provided with full and 
accurate information regarding the risks and benefits of ESDs and 
alternative treatment options, and whether all other options were 
adequately attempted prior to ESD use.

IV. Labeling

    FDA has determined that labeling, or a change in labeling, cannot 
correct or eliminate the unreasonable and substantial risk of illness 
or injury. At the Panel Meeting, only members who opined that ESDs 
present an unreasonable and substantial risk of illness or injury (a 
majority of the entire Panel) were asked whether labeling could correct 
or eliminate this risk, and all concluded that labeling could not 
correct or eliminate the risks or dangers.
    As explained in section II.A, the risks posed by ESDs fall under 
two broad categories, psychological and physical, and these risks are 
heightened when the devices are used to treat patients who exhibit SIB 
or AB because of these patients' vulnerabilities. As explained in 
sections I.C and II.A.1, individuals demonstrate great variability in 
their experience of ESD shocks, including with respect to pain and the 
psychological harms discussed. A person's physical state naturally

[[Page 24412]]

changes continuously, so the body's reaction to ESD shocks will change 
continuously, and a person's mental state further shapes the 
experience. The same electric shock, as characterized by electrical 
current and stimulation site, may affect any given person in a variable 
manner from one shock to another. This variability is seen across 
different individuals, which prevents providers from using one person's 
experience as a guide for another person, and within the same 
individual over time, which prevents providers from using a single 
person's past experience as a predictor of future experiences.
    Labeling cannot correct or eliminate the risks or dangers because 
conditions under which providers could overcome the underlying inter- 
or intrapersonal variability cannot be defined. Predicting an 
individual's resulting experience would require knowing the initial 
psychological and physical states of the person, which is subjective 
information that providers cannot reliably know, especially when making 
a split-second decision whether to apply a shock. Further, individuals, 
especially ones with intellectual or developmental disabilities, may 
not be able to accurately and reliably communicate information 
regarding their physical or psychological state. Thus it would be 
impossible to create broadly applicable labeling that could account for 
these variables; labeling could only warn the provider that it is 
impossible to account adequately for all relevant factors. Because 
labeling cannot correct or eliminate the fact that providers lack 
knowledge required to mitigate the risk of harm, it cannot correct or 
eliminate the risks or dangers posed by ESDs for SIB or AB.
    Labeling also cannot correct or eliminate ESD risks or dangers by 
specifying output parameters, for example, maximum current or optimal 
electrode placement. As explained in section II.A.1, the subjective 
experience, especially in terms of psychological harms, does not 
necessarily vary in proportion to shock strength. Even a relatively 
mild stimulus can trigger or contribute over time to a more serious 
psychological reaction (e.g., Refs. 31-33). Thus it would not be 
possible to provide warnings regarding output parameters to correct or 
eliminate the risks and dangers.
    Labeling also cannot limit the risks to only the most refractory 
patients. As explained, although evidence indicates that a 
subpopulation of refractory individuals may exist, that subpopulation 
is difficult if not impossible to define. The labeling of the GED 
devices, the only ESDs currently in use in the United States of which 
FDA is aware, already includes the statement that ``[t]he device should 
be used only on patients where alternate forms of therapy have been 
attempted and failed.'' Yet the available evidence, discussed in 
section II.C.5, casts doubt on whether JRC in fact applies the devices 
as a last resort after attempting all other approaches, and shows that 
patients JRC considered to be refractory were transitioned successfully 
to other treatments. Thus labeling has failed to limit use of the 
device to patients who do not have other adequate treatment options. 
Further, even if a refractory subpopulation could be defined, as 
discussed in section II.C.4, the possibility that some patients are 
refractory to treatment does not necessarily mean that ESDs would be an 
effective treatment or that the benefits of ESD use outweigh the risks. 
Thus labeling cannot correct or eliminate the substantial and 
unreasonable risk posed by ESDs.
    In his report, Dr. Smith recommends against banning and that FDA 
should instead impose the following restrictions: ``(1) A prescription 
and ongoing, periodic review by a board-certified physician, licensed 
psychologist, or licensed behavior analyst and (2) prior approval and 
ongoing, periodic review by an independent patient-rights committee 
convened by a healthcare organization that is accredited by an 
organization such as the Joint Commission.'' Although FDA does not have 
to consider whether restrictions would obviate the need for a ban, we 
have considered Dr. Smith's proposal and do not believe restrictions 
would correct or eliminate the substantial and unreasonable risk posed 
by ESDs. The only ESDs currently in use are prescription devices and, 
as explained by JRC, ``require multiple levels of review, approval, 
consent and oversight.'' FDA has determined that JRC's measures do not 
adequately mitigate the unreasonable and substantial risk posed by 
these devices. While the measures Dr. Smith recommends are perhaps 
stronger, there is not enough information to determine that such 
measures would adequately mitigate the risks.

V. Application of Ban to Devices in Distribution and Use

    FDA is proposing that the ban apply to devices already in 
commercial distribution and devices already sold to the ultimate user, 
as well as devices sold or commercially distributed in the future (see 
Sec.  895.21(d)(7)). This means ESDs currently in use on individuals 
would be subject to the ban and thus adulterated under section 501(g) 
of the FD&C Act and subject to FDA enforcement action.
    FDA is proposing this because the risk of illness or injury to 
individuals on whom these devices are already used is just as 
unreasonable and substantial as it is for future individuals on whom 
these devices could be used. Indeed, as safer and more effective 
alternative treatments continue to be developed, it is the individuals 
on whom ESDs are currently used for whom the ban may have the most 
impact. The majority of the Panel agreed that, if FDA were to ban ESDs, 
the ban should apply to devices already in use.
    JRC believes that any action ``that would precipitously remove or 
require the eventual removal of the GED from the patients who currently 
rely on this court-ordered therapy would have dire consequences from a 
patient safety and health perspective'' (Ref. 21). According to JRC, 
the GED ``is the only treatment available to these patients''; all 
others were tried and failed. As an example of what could result from a 
mandated, sudden removal of the GED from a patient, JRC explains that 
one patient whose GED was removed against the medical advice of JRC 
health professionals soon resumed self-injurious scratching and picking 
behaviors that led to serious blood and bone infections, paralysis of 
his legs, and eventual death 3 years after leaving JRC (Ref. 139).
    As discussed in section II.C, FDA does not agree that ESDs are the 
only treatment available for individuals exhibiting SIB or AB, no 
matter how severe the behavior may be, and FDA has reason to doubt 
whether all other treatment options were attempted for individuals 
prescribed these devices. FDA has not been able to verify the accuracy 
of JRC's account regarding an individual removed from the GED. However, 
even if accurate, that does not mean that the GED was not harmful to 
the individual, nor does it speak to the extent to which other 
treatments were tried after he left JRC. The only support JRC offers 
for this anecdote is a post on its Web site by Dr. Israel that does not 
include information regarding possible harms from GED use or details 
regarding treatment after the patient left JRC, and JRC states it 
offered the post as an editorial to the New York Times but was 
rejected. In contrast to JRC's assertions, we again note that one study 
described in the literature found that less restrictive interventions 
successfully treated SIB and AB in individuals after ESDs were removed 
(Ref. 95), and that

[[Page 24413]]

Massachusetts DDS has successfully transitioned several patients who 
were subject to ESDs at JRC to providers who do not use ESDs (Ref. 
132).
    However, FDA recognizes that, for certain individuals currently 
subject to ESDs, immediate cessation could possibly result in a 
significant increase of SIB or AB before appropriate alternative 
therapies are in effect, and a more gradual reduction toward complete 
removal may be necessary for some patients, especially those who have 
been subject to ESDs for a considerable amount of time. Thus, to 
account for this possibility, in appropriate circumstances, FDA does 
not intend to enforce the ban for a limited period of time with respect 
to ESDs that continue to be used on patients after the effective date. 
We intend to consider, for example, whether the patient has a 
documented medical need for gradual transition to an alternative 
therapy, as determined by an independent psychiatrist, psychologist, or 
similar State-licensed behavioral expert. We welcome comment on how 
long transitions may take. FDA does not intend to enforce against 
individual patients.

VI. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule 
become effective 30 days after the date of its publication in the 
Federal Register. FDA requests comment on the proposed effective date 
for this proposed rule.

VII. Analysis of Environmental Impact

    FDA has carefully considered the potential environmental effects of 
this proposed rule and of possible alternative actions. In doing so, 
the Agency focused on the environmental impacts of its action as a 
result of disposal of unused ESDs that will need to be handled after 
the effective date of the proposed rule.
    The environmental assessment (EA) considered each of the 
alternatives in terms of the need to provide maximum reasonable 
protection of human health without resulting in a significant impact on 
the environment. The EA considered environmental impacts related to 
landfill and incineration of solid waste. The proposed action would 
result in an initial batch disposal of used and unused ESDs primarily 
at a single geographic location followed by a gradual, intermittent 
disposal of a small number of remaining devices in this and other 
affected communities where these devices are used. The total number of 
devices to be disposed is small, i.e., approximately less than 300 
units. Overall, given the limited number of ESDs in commerce, the 
proposed action is expected to have no significant impact on landfill 
and solid waste facilities and the environment in affected communities.
    The Agency has concluded that the proposed rule would not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. FDA's finding of no significant 
impact (FONSI) and the evidence supporting that finding, contained in 
an EA prepared under 21 CFR 25.40, may be seen in the Division of 
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday. FDA invites comments and submission of data concerning 
the EA and FONSI.

VIII. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the proposed rule. We believe that this 
proposed rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the proposed rule would only affect one entity that 
is not classified as small, we propose to certify that the proposed 
rule would not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $144 million, using the most current (2014) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary of Costs and Benefits

    FDA is proposing to ban ESDs for the purpose of treating self-
injurious or aggressive behavior. Non-quantified benefits of the 
proposed rule include a reduction in adverse events, such as the risk 
of burns, PTSD, and other physical or psychological harms related to 
use of the device in this patient population.
    We expect that the proposed rule would only affect one entity that 
currently uses these devices to treat residents of their facility. The 
proposed rule would impose costs on this entity to read and understand 
the rule, as well as to provide affected individuals with alternative 
treatments. Although uncertain, other treatments or care at other 
facilities may cost more. To account for this uncertainty, we use a 
range of potential alternative treatment costs. At the lower bound, we 
assume that alternative treatments would cost the same as the current 
treatment. We use reimbursement data from the State of Massachusetts to 
estimate a potential upper bound for alternative treatments. The costs 
for the one affected entity to read and understand the rule range from 
$438 to $753. The present value of the incremental treatment costs over 
10 years ranges from $0 to $60.1 million at a 3 percent discount rate, 
and from $0 to $51.4 million at a 7 percent discount rate. Annualized 
costs range from $0 million to $6.8 million at a 3 percent discount 
rate and from $0 million to $6.8 million at a 7 percent discount rate. 
The lower-bound cost estimates only include administrative costs to 
read and understand the rule with no incremental costs for alternative 
treatments. Additionally, there would be transfer payments between 
$11.5 million and $15 million annually either within the affected 
entity to treat the same individuals using alternative treatments, or 
between entities if affected individuals transfer to alternate 
facilities for treatment. The proposed rule's costs and benefits are 
summarized in table 2, ``Economic Data: Costs and Benefits Statement.''
    We also examined the economic implications of the rule as required 
by the Regulatory Flexibility Act. The Regulatory Flexibility Act 
requires us to analyze regulatory options that would minimize any 
significant impact of a rule on small entities. Because the proposed 
rule would only affect one entity that is not classified as small, we 
propose to certify that the proposed rule would not have a significant 
economic

[[Page 24414]]

impact on a substantial number of small entities.
    The full discussion of economic impacts is available in Docket No. 
FDA-2016-N-1111 at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

                                                  Table 2--Economic Data: Costs and Benefits Statement
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Units
                                                        Primary                    ------------------------------------------------
             Category                Low estimate      estimate      High estimate                                      Period              Notes
                                       (million)       (million)       (million)     Year dollars    Discount rate      covered
                                                                                                          (%)           (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized....................
    Monetized $millions/year......
    Annualized Quantified.........
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  Reduction in
                                                                                                                                     physical and
                                                                                                                                     psychological
                                                                                                                                     adverse events
                                                                                                                                     related to use of
                                                                                                                                     the device.
Costs:
    Annualized....................              $0            $3.4            $6.8            2015               7              10
    Monetized $millions/year......               0             3.4             6.8            2015               3              10
    Annualized....................
    Quantified....................
    Qualitative...................  ..............  ..............  ..............  ..............  ..............  ..............  Transition costs to
                                                                                                                                     the affected entity
                                                                                                                                     and individuals for
                                                                                                                                     transitioning to
                                                                                                                                     alternative
                                                                                                                                     treatments.
Transfers:
    Federal.......................
    Annualized....................
                                   ------------------------------------------------------------------------------------------------
    Monetized $millions/year......  From:
                                    To:
                                   ------------------------------------------------------------------------------------------------
    Other Annualized..............            11.5            13.3              $5            2015               7              10
    Monetized $millions/year......            11.5            13.3              15            2015               3              10
                                   ------------------------------------------------------------------------------------------------
                                    From: Affected entity for current treatment
                                    To: Affected entity for other treatments or to
                                    other facilities that treat aggressive or self-
                                    injurious behavior
                                   ---------------------------------------------------------------------------------------------------------------------
Effects...........................  State, Local or Tribal Government: State expenditures may rise or fall if individuals move across state boundaries.
                                    Small Business: No effect.
                                    Wages: No effect.
                                    Growth: No effect.
--------------------------------------------------------------------------------------------------------------------------------------------------------

IX. Paperwork Reduction Act

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

X. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive order requires Agencies to ``construe . . . a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision that preempts certain state requirements ``different from or 
in addition to'' certain Federal requirements applicable to devices. 
(See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic v. Lohr, 
518 U.S. 470 (1996); and Riegel v. Medtronic, 128 S. Ct. 999 (2008)). 
If this proposed rule is made final, it would create a Federal 
requirement under 21 U.S.C. 360k that bans ESDs for AB and SIB.

XI. References

    The following references are on display in the Division of Dockets 
Management (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site addresses, as of the date this document publishes 
in the Federal Register, but Web sites are subject to change over time.

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136. Samuels, J., DOJ, letter, to A. Russell, FDA. Received June 24, 
2014.
137. Donnellan, A.M., University of San Diego, letter, to E.M. Howe, 
Massachusetts Department of Developmental Services, dated July 31, 
2011.
138. Gant, S.A., Gant, Yackel & Associates, Inc., letter, to E.M. 
Howe, Massachusetts Department of Developmental Services, dated 
August 1, 2011.
139. JRC, Inc., public docket comment, FDA-2014-N-0238 (D0291). 
Received May 14, 2014.

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List of Subjects

21 CFR Part 882

    Medical devices, Neurological devices.

21 CFR Part 895

    Administrative practice and procedure, Labeling, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, we propose 
that 21 CFR parts 882 and 895 be amended as follows:

PART 882--NEUROLOGICAL DEVICES

0
1. The authority citation for 21 CFR part 882 continues to read as 
follows:

    Authority:  21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Amend Sec.  882.5235 by revising paragraph (b) to read as follows:


Sec.  882.5235  Aversive conditioning device.

* * * * *
    (b) Classification. Banned when used to reduce or cease aggressive 
or self-injurious behavior. See Sec.  895.105. Otherwise, Class II 
(performance standards).

PART 895--BANNED DEVICES

0
3. The authority citation for 21 CFR part 895 continues to read as 
follows:

    Authority:  21 U.S.C. 352, 360f, 360h, 360i, 371.

0
4. Add Sec.  895.105 in Subpart B to read as follows:


Sec.  895.105  Electrical stimulation devices to treat aggressive or 
self-injurious behavior.

    Electrical stimulation devices to treat aggressive or self-
injurious behavior are devices that apply a noxious electrical stimulus 
to a person's skin to reduce or cease aggressive or self-injurious 
behavior.

    Dated: April 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09433 Filed 4-22-16; 8:45 am]
BILLING CODE 4164-01-P