Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion, 58411-58421 [2017-26704]

Download as PDF ethrower on DSK3G9T082PROD with NOTICES Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices ‘‘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 https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Compliance Policy Staff/Office of Compliance, Center for Food Safety and Applied Nutrition (HFS–605), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two selfaddressed adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance. FOR FURTHER INFORMATION CONTACT: Mischelle B. Ledet, Center for Food Safety and Applied Nutrition (HFS– 605), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–701–5986, or Eric Nelson, Center for Veterinary Medicine (HFV– 230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240–402–5642, or Tyler Scandalios, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857, 240–402–4552. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 I. Background We are announcing the availability of a draft guidance for industry entitled ‘‘Refusal of Inspection by a Foreign Food Establishment or Foreign Government.’’ We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of the FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations. The guidance is not subject to Executive Order 12866. The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353), enacted on January 4, 2011, amended the FD&C Act to expand and enhance our ability to ensure that imported food products meet U.S. standards and are safe for consumers. Among the FSMA changes to the FD&C Act, we now must refuse admission of a food into the United States if it is from a foreign factory, warehouse, or other establishment of which the owner, operator, or agent in charge, or the government of the foreign country, refuses to permit entry of United States inspectors or other individuals duly designated by the Secretary of Health and Human Services, upon request, to inspect such factory, warehouse, or other establishment (section 807(b) of the FD&C Act (21 U.S.C. 384c(b))). In addition, the FD&C Act, at section 807(b), states that an owner, operator, or agent in charge is considered to have refused an inspection if the owner, operator, or agent in charge does not permit an inspection of a factory, warehouse, or other establishment during the 24-hour period after we submit an inspection request, or after such other time period, as agreed upon by FDA and the foreign factory, warehouse, or other establishment. This draft guidance, when finalized, will provide information for foreign food establishments subject to our inspection, as well as foreign governments, on when we may consider that a foreign food establishment or a government of a foreign country has refused to permit an inspection by us as provided in section 807(b) of the FD&C Act. II. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/FoodGuidances or https://www.regulations.gov. Use the FDA website listed in the previous PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 58411 sentence to find the most current version of the guidance. Dated: December 6, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26692 Filed 12–11–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–N–4487] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA). SUMMARY: Fax written comments on the collection of information by January 11, 2018. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202– 395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910—New and title ‘‘Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion.’’ Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A–12M, 11601 Landsdown St., North Bethesda, MD 20852, 301–796–7726, PRAStaff@ fda.hhs.gov. DATES: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: E:\FR\FM\12DEN1.SGM 12DEN1 58412 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Promotion OMB Control Number 0910—NEW ethrower on DSK3G9T082PROD with NOTICES I. Background Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act. Under the FD&C Act and implementing regulations, promotional labeling and advertising about prescription drugs are generally required to be truthful, nonmisleading, and to reveal facts material to the presentations made about the product being promoted (see FD&C Act sections 201(n) and 502(a) and (n) (21 U.S.C. 321(n) and 352(a) and (n)); see also 21 CFR 202.1). Prescription drug promotion sometimes includes false or misleading (collectively, deceptive 1) claims, images, or other presentations; for instance, representations that a drug is more effective or less risky than is demonstrated by appropriate evidence. A number of empirical studies have examined the occurrence and influence of deceptive promotion, both in regard to prescription drugs (Refs. 1 and 2) and other products (Refs. 3 and 4). No research to our knowledge, however, has investigated the ability of consumers and healthcare professionals (HCPs) to independently identify deceptive prescription drug promotion. The ability of consumers and HCPs to identify deceptive prescription drug promotion has important public health implications. If unable to identify deceptive promotion, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs who are unable to identify deceptive promotion may prescribe specific drugs that they would 1 Our use of the term deceptive is not meant to imply equivalence (or lack thereof) with use of the same term by the U.S. Federal Trade Commission. As used in this document, this term refers to presentations that are considered false or misleading within the context of prescription drug promotion. VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 not otherwise prescribe. On the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive promotion to appropriate government regulators who can take corrective action. Reports of deceptive promotion are useful to FDA because they allow investigators to focus their efforts in an era where the amount of promotion far exceeds the resources available to review everything. The FDA Bad Ad program, for example, encourages HCPs to report deceptive prescription drug promotion (Ref. 5), a goal which requires that HCPs successfully identify such promotion when it appears in the course of their duties. Likewise, similar programs could be implemented for consumers to report deceptive prescription drug promotion to FDA. The mission of the Office of Prescription Drug Promotion (OPDP) within FDA is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, and to guard against deceptive promotion through comprehensive surveillance, enforcement, and educational programs. As part of this mission, it is critical that OPDP adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as these populations’ processing of such claims. This understanding will help OPDP to identify best practices for addressing false and misleading claims in prescription drug promotion. The research described here will provide evidence to inform consideration of the approaches best suited to fulfill OPDP’s mission to protect the public from deceptive promotion. The proposed project involves two studies examining volunteer participants’ ability to detect and report deceptive presentations in prescription drug promotion. The studies will be conducted concurrently and will focus on different health conditions. Each study will be administered to two separate populations (i.e., HCPs and consumers affected by the condition). HCPs will view mock pharmaceutical websites targeted toward physicians and consumers will view mock consumer- PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 targeted pharmaceutical websites. The goal will be to keep the HCP and consumer-targeted websites as similar as possible, but to include content that is appropriate for the target audience. For example, HCP websites may contain medical terminology, whereas the consumer websites would utilize consumer friendly language. A professional firm will create all mock websites such that they are generally indistinguishable from currently available prescription drug websites. II. Study 1 and 2 Study 1 and 2 sample. Study 1 will sample consumers who self-report chronic pain that has lasted at least 3 months and HCPs whose primary medical specialty is either primary care or internal medicine and whose responsibilities involve direct patient care at least 50 percent of the time. Chronic pain has an incidence rate of roughly 11 percent (Ref. 6) in the population. Study 2 will sample consumers who self-report obesity, defined as body mass index greater than or equal to 30 (35 percent incidence; Ref. 7) and include the same types of HCPs as study 1. For both consumers and HCPs, pretest participants will not be eligible for the main study. Pretesting. Pretesting will take place before the main studies to evaluate the procedures and measures used in the main studies. Each of the two pretests will have the same design as its respective main study (pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both pretests will be to: (1) Ensure that the mock websites are understandable, viewable, and delivering intended messages; (2) identify and eliminate any challenges to embedding the mock websites within the online survey; (3) ensure that survey questions are appropriate and meet the analytical goals of the research; and (4) pilot test the methods, including examining response rates and timing of survey. The two pretests will be conducted simultaneously. Based on pretest findings, we will refine the mock websites, survey questions, and data collection process, as necessary, to optimize the full-scale study conditions. Main studies. The proposed design for the main studies, including sample sizes, is summarized below and described next. E:\FR\FM\12DEN1.SGM 12DEN1 58413 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices STUDY 1—DEGREE OF DECEPTION BASED ON THE NUMBER OF DECEPTIVE CLAIMS Experimental condition Population None (control) HCPs ................................................................................................................ Consumers w/chronic pain .............................................................................. Fewer violations 125 125 More violations 125 125 Total 125 125 375 375 STUDY 2—TYPE OF DECEPTION BASED ON IMPLICIT AND EXPLICIT CLAIMS Experimental condition Population None (control) ethrower on DSK3G9T082PROD with NOTICES HCPs ................................................................................................................ Obese consumers ............................................................................................ The purpose of Study 1 is to assess consumer and HCP response to promotional websites with varying levels of false or misleading presentations. In Study 1, degree of deception will be manipulated over three levels by altering the number of deceptive claims (none, fewer, more). It is possible that consumers and HCPs are only able to identify ads as deceptive when they include a greater number of violations, whereas ads with few violations may not be identified as deceptive. The experimental stimuli will be in the form of a web page for a fictitious drug targeted toward consumers who have chronic pain or toward HCPs. The deceptive websites will contain various types of violations. The website with fewer violations will contain a subset of the deceptive claims, imagery, or other presentations included in the website with more violations. For example, if the fewer-violations website includes two violations, then the moreviolations website will include the same two violations plus two or three additional violations (in the form of claims and/or graphics). Study 1 will help FDA address several key questions: • What proportion of consumers and HCPs correctly identify a promotional piece as deceptive? Does the ability to identify deceptive promotion vary depending on the number of deceptive claims in a promotional piece? • Does the degree of deception affect consumers’ and HCPs’ attitudes and behavioral intentions toward the promoted drug, including intended reporting to regulatory authorities? • Is the effect of deceptive promotional pieces mediated by a person’s ability to identify a promotional piece as deceptive (that is, do people who recognize a piece as deceptive discount the information in the piece, thereby adjusting their VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 125 125 attitudes and intentions toward the product)? Whereas Study 1 focuses on the level of deception (based solely on the number of false or misleading claims), Study 2 focuses on the type of deception (implicit versus explicit). Many deceptive promotional claims are implicit rather than being explicitly false (Refs. 1 and 4). An implicit claim suggests or implies an unstated piece of information. An explicit claim fully and clearly expresses information and leaves nothing to be implied. Study 2 will compare perceptions and beliefs that consumers and HCPs hold about a drug following exposure to one of three versions of a prescription drug website: (1) An explicitly false website, (2) a factually true but implicitly misleading website, or (3) a website with no deceptive claims (the control group). As with Study 1, we envision a pair of one-way factorial experiments, one conducted with a sample of consumers and the other with HCPs. Similar to Study 1, Study 2 will investigate how misleading implicit claims and explicitly false claims in prescription drug promotional pieces influence a person’s ability to detect and respond appropriately to deception. The experimental stimuli will be in the form of a mockup of a pharmaceutical website targeted toward the relevant experimental population, obese consumers or HCPs who treat obese patients. As with study 1, the drug profile, including indication, risks, and logo branding will be fictitious. For the implicit misleading claim manipulations, we are interested in whether people infer false beliefs from the implicit communications. Study 2 will help FDA address several key questions: • What proportion of consumers and HCPs correctly identify a promotional piece as deceptive? Does the ability to PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 Implicit Explicit 125 125 Total 125 125 375 375 identify deceptive promotion vary depending on whether deceptive claims in a promotional piece are explicit versus implicit? • Does the type of deception affect consumers’ and HCPs’ attitudes and behavioral intentions toward the promoted drug, including intended reporting to regulatory authorities? • Is the effect of deceptive promotional pieces mediated by a person’s ability to identify a promotional piece as deceptive (that is, do people who recognize a piece as deceptive discount the information in the piece, thereby adjusting their attitudes and intentions toward the product)? Measurement. Identifying how to measure consumers’ and HCPs’ ability to identify deceptive promotion as well as their reaction to such promotion is fundamental to achieving the research goals. A literature review revealed the importance of using a variety of measures to capture detection of deception. For direct measures, we will incorporate questions that ask participants to indicate whether there was any deception in the promotional piece and to rate the promotional piece in terms of how deceptive, credible, or trustworthy it was. Additionally, we will include claim-specific direct measures that allow people to click on any part of the website that they deem deceptive. Using responses to this variable, we can assess whether participants think there is any deception in a promotional piece; in instances where they do think there is deception, we can assess what aspects of the website contributed to that belief. We will also include indirect measures that identify whether participants believed the website expressed particular claims (e.g., claim recognition) as well as participants’ beliefs about the veracity of any deceptive claims (e.g., claim E:\FR\FM\12DEN1.SGM 12DEN1 ethrower on DSK3G9T082PROD with NOTICES 58414 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices truth, agreement, or acceptance). Moreover, we will assess whether participants believe the messages merit reporting to regulatory authorities (that is, FDA). To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. A copy of the draft questionnaire is available upon request. In the Federal Register of January 4, 2017 (82 FR 855), FDA published a 60day notice requesting public comment on the proposed collection of information. Comments received along with our responses to the comments are provided below. Comments that are not PRA-relevant or do not relate to the proposed study are not included. For brevity, some public comments are paraphrased and therefore may not reflect the exact language used by the commenter. We assure commenters that the entirety of their comments was considered even if not fully captured by our paraphrasing. Question numbering here (e.g., Q30) reflects numbering from the original draft questionnaire, shared by request at the time of the 60-day notice. The following acronyms are used here: FRN = Federal Register Notice; DTC = direct-to-consumer; HCP = healthcare professional; FDA and ‘‘The Agency’’ = Food and Drug Administration; OPDP = FDA’s Office of Prescription Drug Promotion. (Comment 1) regulations.gov tracking number 1k1–8ubr–t0de (verbatim with header and footer language removed): We are supportive of the study, but have the following recommendations. We propose that additional study arms be included that explore various scenarios/websites which test both the number of deceptive claims in conjunction with the degree of deception. Currently, the study is structured to measure the impact of the number of deceptions in a promotional website (Study 1) separately from the degree of the deception (explicit vs implicit, in Study 2). However, it would also be beneficial to measure other combinations to see which factor or combination of factors had the greatest impact on HCPs and Consumers’ overall perception of the website. For example, a single explicit lie may be more impactful than 15 implied deceptions. The current study will not be able to draw any conclusions regarding that scenario. Testing additional combinations of the number of deceptions in a website along with deceptive claims of varying severity would enable a better comparison and understanding of what ultimately drives HCPs and Consumers’ perception of deceptive prescription promotion. VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 (Response) We thank the commenter for their support and for this suggestion. While certainly a viable research idea, cost implications of creating and testing additional stimuli for this purpose bar us from pursuing it. We encourage researchers to pursue this idea in future research. (Comment 2) regulations.gov tracking number 1k1–8v15–11b6 (some comments summarized for brevity; others provided verbatim): a. Given the stated purpose of the pretests, sample size can be substantially reduced, and revised to a qualitative approach. (Response) In addition to the quantitative pretest, we have already conducted a qualitative test of stimuli and questionnaire materials via cognitive interviews. Changes based on cognitive interviews are reflected in our updated survey materials. In regard to sample size, the number of pretest participants per experimental condition (n = 50) was chosen based on a power analysis, and is considered to be the minimum effective size to allow for assessment of the quantitative outcomes specified in the 60-day FRN. Examples of quantitative outcomes include assessment of response rates and timing of the survey. b. To reduce bias, add a screening question to exclude respondents who are opposed to taking prescription medicines. (Response) The survey length does not allow for a full exploration of attitudes toward prescription drug use. However, to assess opposition to prescription drug use more generally, we added one item to the survey that has been used successfully in previous FDA surveys. This item will be used in the pretest survey as a potential covariate and may or may not be retained in the main study survey depending on its performance. The item reads: ‘‘In what situations would you consider taking prescription drugs?’’ • I would never take them. • I would take them only for serious health conditions. • I would take them for moderate and serious health conditions. • I would take them for most health conditions, including minor problems. c. Consider revising item scales to include a mid-point to allow respondents to express neutral views (unless objective is to force a selection). (Response) Given the focus of the questions, we believe that offering a neutral response option is not necessary to measure opinions and attitudes accurately. Consequently, our objective is to force a selection and have PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 participants make at least a weak commitment in either a positive or negative direction. Of concern is that offering a neutral midpoint could potentially encourage ‘‘satisficing’’— cuing participants to choose a neutral response because it is offered (Ref. 8). Additionally, providing a midpoint leads to the loss of information regarding the direction in which people lean (Ref. 9). Research has found that neither format (either with or without a neutral point) is necessarily better or produces more valid or reliable results (Ref. 10). Instead, it should be left to the researcher to determine the goals of the study. During cognitive testing, a majority of participants were satisfied with the response options and all participants felt comfortable choosing a response in the absence of a midpoint. Use of a midpoint is an issue we have examined in previous studies and we determined that we achieve valid and reliable responses without a midpoint. To increase consistency with measures used in previous studies, and in support of the arguments presented above, we are opting to exclude a midpoint. Finally, if a participant does not feel that they can choose a response because of a lack of a neutral option, they will be able to skip the question. d. In Study 1, remove Q21 and Q30 due to potentially leading nature of items. (Response) To avoid redundancy, we dropped Q21. In Q30, we ask participants to click on anything they think is misleading, and we note that if they do not think anything is misleading, they can click ‘‘none.’’ Consequently, we are not strongly presupposing there are misleading claims. To address some of the wording concerns for this item, we changed the question to ask about inaccurate information instead of misleading information and we moved the ‘‘None’’ response to be more prominent above the image. (Comment 3) regulations.gov tracking number 1k1–8v3z–nzst (summarized for brevity): The commenter expresses concern about the practical utility of the research, reasons for which are covered by comments 3a through 3e. In the case that FDA continues with the research, the commenter makes several recommendations which are covered by comments 3f through 3cc. Comments 3f through 3h concern the study stimuli, comment 3i pertains to subject recruitment, and comments 3j through 3cc concern the study questionnaires. a. The identification of deceptive promotion is FDA’s assigned E:\FR\FM\12DEN1.SGM 12DEN1 ethrower on DSK3G9T082PROD with NOTICES Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices responsibility, not the duty of HCPs and consumers. (Response) As discussed above, the mission of OPDP within FDA is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated, and to guard against false and misleading promotion through comprehensive surveillance, enforcement, and educational programs. As part of this mission, it is critical that OPDP adequately understand the capacity of consumers and HCPs to detect false and misleading claims as well as these populations’ processing of such claims. This understanding will help FDA/OPDP to identify best practices for addressing deceptive claims in prescription drug promotion. Moreover, we note that sponsors are not generally required to submit promotional pieces to FDA prior to dissemination, and limited resources prevent OPDP from reviewing all promotional materials in the marketplace. Voluntary HCP and consumer reporting of false and misleading promotional pieces contribute to the accomplishment of FDA/OPDP’s mission. b. Deceptive drug promotion is not a prevalent issue that requires further studying. (Response) Numerous studies have examined the prevalence of false or misleading claims and presentations in DTC advertising, and FDA frequently issues compliance letters addressing false and misleading claims and presentations (Refs. 1 and 2). Consequently, FDA disagrees with this assertion. c. FDA’s proposed studies fail to acknowledge the role of the HCP as the ‘‘learned intermediary.’’ (Response) The present research takes into consideration both consumer and HCP responses to false or misleading promotion. Consumers often wish to participate in shared decision making with HCPs when selecting prescription drugs and may request specific prescription drugs from their HCPs based on promotions they have seen in the marketplace. Because information consumers receive through DTC prescription drug promotion can impact these requests, it is important to investigate consumers’ ability to assess prescription drug product efficacy and risks as conveyed in promotional pieces. And although HCPs have medical training and clinical expertise, we are not aware of research that investigates whether such training and expertise translates into an ability to detect false or misleading promotion in the marketplace. Consequently, the present VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 research investigates both consumer and HCP ability to identify and discount deceptive prescription drug promotion. d. The proposed studies are duplicative of recent FDA research concerning HCP willingness to report deceptive promotion. The commenter suggests that if FDA wishes to investigate consumer reporting, the Agency should create two separate studies. The first should gauge consumer aptitude in identifying false or misleading prescription drug promotion. Depending on the results of the first study, the Agency could potentially undertake a second study, surveying subject willingness to report false or misleading drug promotion. This approach would avoid potential error associated with influence of earlier questions regarding deception on later questions regarding reporting. (Response) FDA conducted a survey of HCPs in 2013 in which respondents were asked about their familiarity with the Bad Ad program and willingness to report misleading advertising (Ref. 5). The current study is quite different in scope from the previous research. The current study consists of an experimental design that will enable us to determine whether HCPs can detect misleading advertising, not just whether they are willing to report it. We do include questions at the end of the survey asking similar questions as those in the 2013 survey, but the purpose here is in connection to HCP ability to detect misleading advertising. Moreover, our use of similar questions here reflects a well-established technique in scientific research, used to determine whether previous findings can be replicated or not. In response to the second comment recommending division of this project into two separate studies, we believe that proposal to be an inefficient use of resources. Regarding concerns about the order of questions affecting subsequent responses, we chose to distribute deception-related items throughout the survey, rather than ask all deception items first and then other outcome measures second. Also, we include ‘‘masking’’ items on the same screen as deception-related items to mask the intent of the questions. The results from cognitive interviews confirm that this approach was successful. Consequently, we have no evidence to suggest that earlier questions related to deception will influence subsequent questions related to reporting. e. FDA already has created and implemented consumer programs to report deceptive promotion. (Response) The proposed research can inform program needs at present, PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 58415 whether such needs involve reevaluation of past programs such as EthicAd, or extensions of existing programs such as the Bad Ad program or other actions. f. Validating Stimuli. It is not clear how the Agency will determine that a study stimulus is deceptive. FDA notes in the PRA Notice that the ‘‘term deceptive is not meant to imply equivalence (or lack thereof) with use of the same term by the U.S. Federal Trade Commission.’’ It seems unrealistic for FDA to conduct research with primary care physicians (PCPs) and consumers who do not understand the Agency’s standards or have access to the training and resources of an FDA reviewer. Further, except for literal falsity, whether a particular communication is false or misleading must be based on empirical evidence. Promotional pieces do not exist in a vacuum. These communications interact with the overall health information ecosystem, including the internet. FDA needs to first validate that the study stimuli are indeed deceptive before including the stimuli in either proposed study with the presumption that they are deceptive. (Response) Our reference to the Federal Trade Commission’s (FTC) definition of the term ‘‘deceptive’’ was offered as a point of clarification for our use of the same term as shorthand within the FRN for the longer phrase ‘‘false or misleading.’’ In other words, by using ‘‘deceptive’’ as a term of art in this narrow context, we are not evoking the specific meaning and interpretation of the same term used by the FTC. We disagree with the suggestion that participants need to have access to the training and resources of an FDA reviewer before FDA can evaluate their ability to identify deceptive promotion. As further explained below, FDA is not asking participants to determine whether nuanced text meets the regulatory standards for deceptive promotion; instead, we are presenting material that meets both the regulatory standard for a deceptive promotion and could be identified as such by consumers or healthcare providers with no prior experience with the regulations. We agree with the second point about the need to validate that the study stimuli are deceptive, and we are doing this in several ways for this study. For example, some of the specific claims used in our experimental manipulations are established as being factually incorrect because the promoted drug is a member of a class of drugs for which the claim could not be true (e.g., describing a serotonin-norepinephrine reuptake inhibitor (SNRI), which is E:\FR\FM\12DEN1.SGM 12DEN1 ethrower on DSK3G9T082PROD with NOTICES 58416 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices required to have a black box safety warning for suicide risk, as lacking in significant safety concerns). Other claims or presentations in the stimuli are based on similar claims cited as violative in past warning letters or that unambiguously fail to follow the law (e.g., minimizing presentation of important safety information, such as a black box warning, by setting it in small, low contrast type). For one manipulated claim, we provided participants with access to the background information needed to identify the presentation as deceptive in the form of a footnote. In the case of Study 2, where a crucial aspect of the experimental design is to test an implicitly misleading claim in relation to an explicitly false claim and against a nonviolative control, we tested candidate claims in cognitive interviews to verify that the audience tended to interpret the implicit claims as intended. Further, it is important to note that we included a control condition in both studies, which will enable us to compare responses to a website that has no violations. The control conditions serve as a baseline for perceived deception, which will also allow us to examine how consumers and providers perceive websites with no violations. g. Media. The Agency proposes using websites as the only stimuli. FDA should consider testing additional nonelectronic media, including DTC and HCP print promotional materials. The Agency should also base the promotional stimuli on realistic ‘‘mock’’ package insert (PI) documents. The commenter requests that FDA make available for public comment these materials. (Response) Previous research on DTC and HCP-directed prescription drug promotional materials has, to varying extents, included all available media formats, and assessment of outcomes using these formats has proven useful. We agree that investigating recognition of misleading prescription drug information in multiple formats— including print, television, web, and other modes—would be valuable. However, we also recognize that no single study can effectively examine all promotional formats or presentations, and we chose to focus on branded drug websites for several reasons. First, websites, while not necessarily more or less useful than any other format, are arguably quite prevalent and important in today’s technological age where a large segment of the consumer population is connected to the internet and known to seek information regarding prescription drugs using the internet. For example, online promotion VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 is the fastest growing category of DTC drug marketing, and branded websites account for the largest share of this category (Ref. 11). Second, almost all print and television ads for prescription drugs encourage viewers to visit branded websites for more information, making these sites an important extension of promotion in other formats (Ref. 12). Third, FDA has issued multiple warning and notice of violation letters for branded drug websites that incorrectly communicate information to visitors, suggesting that there may be a problem with a proportion of such sites presenting misleading information. Fourth, websites serve as a fairly newer format for promotion relative to television and print promotion, and by consequence warrant further study. There has been significantly less research on consumer and provider interpretation of branded drug websites than other promotional formats (Ref. 13), and the extant research suggests that some websites still do not present a fair balance of risk and benefit information (Ref. 14). Based on these considerations, we believe that focusing this study on branded drug websites will be the most effective use of FDA’s limited resources. The fictitious websites included in this study were modeled on real products (including the package insert) to ensure realism and relevance. In response to the request to share stimuli, we generally do not share stimuli before the study has been conducted to avoid possible inadvertent publication and therefore contamination of the subject pool, which would compromise the research. h. Disease States. The Agency’s two studies propose testing stimuli concerning chronic pain or obesity. The commenter suggests that FDA instead consider testing stimuli featuring a fictitious product for a disease state which involves more complex safety information. Such stimuli would be more reflective of the current healthcare environment, where product labeling is increasingly complex. (Response) The fictitious websites used in this research do include complex safety information, which reflect the risks for real chronic pain and obesity products in the marketplace. For example, one of the fictitious products includes a black box warning, and the other includes severe and complex safety information, such as potential drug interactions and contraindications. i. Study 1 Stimuli. In Study 1, the ‘‘degree of deception will be manipulated over three levels by altering the number of deceptive claims PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 (none, fewer, more).’’ FDA states that the deceptive claims will include ‘‘various types of violations.’’ Under the potential design, the most egregious deceptive claim(s) might only be contained in the ‘‘more’’ level. This could potentially skew study results, as subjects would be more likely to identify such egregious claims. FDA should develop a scale that is used to determine the egregiousness of the deception. The scale should include specific examples of egregiousness by category. (Response) Although some claims do not overlap between the ‘‘fewer violations’’ and ‘‘more violations’’ conditions, we strategically manipulated the stimuli so that one of the more ‘‘egregiously’’ deceptive claims (which appears in a callout bubble) is present in both conditions. There is also overlap in those two conditions for another manipulated element, where we minimized the prominence of the Important Safety Information. Additionally, we included an item (Q30) that would provide participants the opportunity to click on anything they think may be inaccurate. Using this question, we would expect that the more egregious claims will be chosen more often. In this way, this item would serve as a proxy measure of egregiousness. Further, our various questions that ask about perceived deceptiveness of the websites will provide an initial assessment of the degree of deception—with higher scores representing greater perceived deception. Because of space constraints on the survey, we are unable to ask participants to rate the egregiousness of the violative claims. Although we appreciate the value that developing a scale to determine the egregiousness of each of the deceptive claims would add, adopting this suggestion in the present research would be outside of the scope of this study and would have an impact on overall cost considerations. j. FDA proposes that the HCP samples for both studies will only include physician subjects. The commenter believes the samples should include other types of HCPs, including nurse practitioners, physician assistants, and pharmacists. As the Agency’s recent research showed, ‘‘Nurse practitioners and physician assistants tended to see the [Bad Ad] program as more useful than [PCPs] and specialists. They also reported a greater likelihood of reporting false or misleading advertising in the future.’’ Given these findings, it would be helpful also to investigate the ability of other HCPs independently to identify false or misleading promotion. E:\FR\FM\12DEN1.SGM 12DEN1 ethrower on DSK3G9T082PROD with NOTICES Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices Additionally, during the recruiting process, FDA should ensure enrollment of a diversity of subjects across demographic categories. Previous research indicates that certain demographic groups respond to drug promotion in different manners. Uneven representation within certain categories could potentially skew study results. (Response) FDA acknowledges and agrees with the assertion that including other types of HCPs in this research would provide value. Yet, sampling from these additional groups requires funding that may not be justified in this initial investigation of the topic area. Nonetheless, we do intend to strive for diversity in both our HCP and consumer samples. HCPs and consumers will vary in terms of age, race, and ethnicity, and consumers will additionally vary in terms of their education level. k. Leading Questions. The overall format of the questionnaires is quite leading. As previously mentioned, questions asking whether sample advertisements are ‘‘deceptive,’’ ‘‘misleading,’’ ‘‘bad,’’ and ‘‘not believable’’ could easily pollute data from later questions inquiring whether a subject would potentially report such promotion to FDA. The Agency should state all questions in an objective manner. (Response) Leading questions are those that ‘‘suggest a possible answer or make some responses seem more acceptable than others’’ (Ref. 15). In keeping with standard practice for balancing the valence of attitudinal questions, we have included a mix of positive and negative statements in the questionnaire. In fact, there are presently more positively framed items than negatively framed items. Moreover, the slider questions referenced by the commenter are semantic differentials, which show both a negatively framed word and its positive counterpart on opposite ends of the response scale (e.g., ‘‘deceptive/truthful,’’ ‘‘misleading/ accurate,’’ ‘‘not believable/believable’’). We do not see how these items could be construed as leading because both the positive and negative frames are presented. Finally, as stated in our response to Comment 3d, we have evidence to suggest that we successfully masked the true focus of the questionnaire, so the deception-focused items should not bias subsequent responses. l. Recall Questions. Certain questions (e.g., Q1–Q3 of Study 1, Q4 of Study 2) ask test subjects to recall specific risks and side effects of the featured drug products. Such questions are not valid instruments to assess whether a subject perceives a stimulus to be false or VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 misleading. Recall is likely influenced by the presentation of the content (e.g., size, visual display), not by the content itself. This research, however, is not material to the stated purpose of the studies. The recall questions should be omitted from the questionnaires. (Response) Q1–Q2 of Study 1 measure risk recall and risk recognition. These are important outcome measures for our study because we vary how the risks are presented in the different experimental conditions, minimizing them (in terms of size and format) in the violative conditions. Including these risk recall and recognition measures allow us to test whether minimizing the risks influences participants’ ability to remember them. Further, because minimization of risk is a misleading violation in its own right, reduced risk recall or recognition among participants in the violative conditions would provide relevant context for interpreting more direct measures of deception. Q4 of Study 2 will enable us to determine if participants can recall seeing the disclosure statements in the websites. This is relevant to the question of whether participants identify false or misleading content because the disclosure statement provides information that would help participants assess the truth of the headline claim. None of these items are intended to be direct measures of whether the stimuli are misleading; instead, they are outcomes that may be affected by misleading content. m. Repetitive Questions. The questionnaires are repetitive in nature. For example, in Q4–Q11 of Study 1, subjects are asked a series of eight questions to measure ‘‘Perceived Website Deception.’’ The questions are redundant (e.g., Believable/Not believable, Truthful/Deceptive, Factual/ Distorted, Accurate/Misleading). This duplication may cause the subject to believe the promotional material is actually false or misleading. (Response) The use of multiple items to tap into a singular construct is considered a best practice in social science research, particularly when assessing complex psychological constructs like those in this survey. Our intent is to combine responses to these items into a single composite score. Our cognitive interviewing of these items suggests that they have slightly different meanings for many participants and thus are not viewed as completely redundant. Further, there is no evidence to suggest that the use of multiple items to assess this construct led participants to believe that the promotional material was actually false or misleading or that this series of questions was designed to PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 58417 capture whether they thought the website was misleading. Consequently, we successfully masked the true intent of this item by including other bipolar response options unrelated to misleadingness. We dropped Q21 to reduce redundancy across items. n. Definitions and Terms. The questionnaires do not define certain key terms (e.g., effectiveness, risk, misleading). Subjects, especially consumers, may interpret these terms based on different standards. FDA might consider providing user-friendly definitions for the consumer subjects. The Agency should also utilize patientfriendly medical terms, rather than complex terminology (e.g., glaucoma, hepatic failure, SNRI). (Response) Sophisticated medical terminology will only be used in the HCP survey. To use the example of ‘‘hepatic failure,’’ consumers will instead see ‘‘decreased liver function.’’ We have verified in cognitive interviews that preceded this study (and in our previous scale development efforts) that the terminology used is generally well understood by our participant sample. o. Sliding Scale Format. FDA should consider replacing the sliding scale format with a ‘‘Yes-No-I Don’t Know’’ scheme. The sliding-scale format is at times confusing in form and could potentially introduce error. Alternatively, the Agency should consider changing the sliding scale to an odd number system to permit a ‘‘neutral’’ response and/or use a variation of the Likert scale. (Response) Use of a sliding scale allows for greater precision and variation in response, as opposed to a ‘‘Yes-No-Don’t Know’’ format. Research suggests that scales with five to seven points are more valid and reliable than those with only two to three categories (Ref. 16). Additionally, we tested the sliding-scale format in previous cognitive interviews and found that it worked well; participants had little difficulty understanding this format. Further, as noted in the response to Comment 2c, we want to avoid leading participants to choose a ‘‘Don’t know’’ response; providing this option may cue participants to select this response and avoid deeper thinking on the topic. Regarding the use of an even numbered scale rather than odd numbered scale, please see our response to Comment 2c. p. An ‘‘FDA employee’’ category should be added to Question S2 [Consumer] of Study 1. These individuals should also be terminated from the study. (Response) Consistent with previous surveys, we added a category to exclude E:\FR\FM\12DEN1.SGM 12DEN1 ethrower on DSK3G9T082PROD with NOTICES 58418 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices employees of the Department of Health and Human Services, which includes employees of FDA. q. Question S3 [Consumer] of Study 1 should be rewritten as follows: ‘‘Have you ever been diagnosed with chronic or long-lasting pain (more than aches and pains that go away quickly or are minor)?’’ (emphasis added). This change aligns the question with the description of the study in the PRA Notice: ‘‘Study 1 will sample consumers with diagnosed chronic pain that has lasted at least 3 months.’’ (Response) We did not restrict people to be diagnosed with chronic pain because the prevalence was too small, which would increase the costs of the study. Using our current screening questions, we achieve an 11 percent prevalence rate (Ref. 6). The objective of our sampling plan is to target people that would be in the audience for the ads; being diagnosed is not a criterion. r. Question S5 [Consumer] of Study 1 should be eliminated. Whether a subject still has chronic pain has no bearing on the study’s purpose. Also, consider eliminating Question Q12 of Study 1. This question would only apply to those consumers currently being treated for chronic pain, not those who previously had the condition. (Response) Assessing whether participants currently experience chronic pain helps to ensure a motivated sample for which the fictitious medication would potentially be of interest. Originally, we included participants that reported suffering from chronic pain in the past, but we did not require that they are currently suffering from chronic pain (although we had an item that asked ‘‘Do you still have this chronic or long-lasting pain?’’). After further consideration, we opted to revise the screener so that participants remain eligible if (a) they say ‘‘Yes’’ I still have chronic pain, or (b) they say ‘‘No’’ (or remain silent) about still having chronic pain and they are currently taking a prescription drug for chronic pain. This would also make the inclusion criteria for Study 1 consistent with the inclusion criteria for Study 2, which requires that a person currently suffers from the medical condition of interest. Consequently, Q12 of Study 1 will be relevant for all consumers completing the questionnaire. s. Consider revising Question S5 [PCP] of Study 1 to inquire: (1) What percentage of the PCP’s patients has each condition, and (2) how long the PCP has treated patients with each condition. A PCP’s familiarity and experience with the treatment of the particular condition provides context and serves as a reference for detecting VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 any potential deception in promotional materials. (Response) We appreciate how these additional questions could provide valuable context and propose adding new items to our pretest survey (see below). We have found, in past work, that HCPs often have difficulty recalling precise information about their practice. Consequently, our approach is to assess this information more generally. However, to include some additional context, we included two additional items: • Rate your current knowledge about prescription drugs for [weight loss/ chronic pain] on a scale of 0 to 10, where 0 means knowing nothing and 10 means knowing everything you could possibly know about the topic. • [If ‘‘chronic pain’’] Approximately what proportion of your current patients do you treat for chronic pain? (None or very few have chronic pain; a small proportion have chronic pain; about one-half have chronic pain; a large proportion have chronic pain; almost all have chronic pain). t. Question Q2 of Study 1 should have a third answer choice: ‘‘Don’t remember.’’ (Response) In cognitive interviews, very few people chose this response option. Moreover, in previous research, because so few people chose this response option, we often end up collapsing this response option with the response indicating that the referent was not mentioned in the website. u. Questions Q5 and Q7 of Study 1 should be deleted. Whether a subject considers the website to be ‘‘Bad/Good’’ or ‘‘Boring/Interesting’’ has no relevance to FDA’s study goals. (Response) These items help to mask the overall intent of the other items in this series (e.g., to assess whether the website is misleading). Also, they provide useful information about personal relevance and attitude toward the website, which we can use as potential covariates. v. The commenter recommends revising Question Q17 of Study 1: ‘‘How likely are you to ask your doctor about [Drug]?’’ (Response) The intent of this item is to assess information-seeking more broadly, which can include, but is not limited to, asking one’s doctor about a drug. While assessing how consumers access information from various sources (doctor, family members, etc.) is of interest, our survey does not have room to ask about each source individually. Given that there are multiple sources of information a consumer might consult for more information on a drug, we decided to address information-seeking PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 more broadly with one question, rather than attempting to list all possible options. w. Questions Q19 and Q21 of Study 1 should be removed. These questions require participants to guess whether the material would mislead people or ‘‘takes advantage of less experienced’’ consumers/providers. FDA should only ask participants about individual perception. Additionally, it is unclear what the Agency means by ‘‘takes advantage of less experienced’’ consumers/providers. (Response) To avoid redundancy, we dropped Q21. We retained Q19 to ensure assessment of a critical construct. Because deception is a complicated construct to measure, we included a variety of items to capture the various dimensions of this construct. Based on a review of the literature, we recommend using a variety of relatively sensitive measures of ability to detect misleading advertisements to ensure we capture potentially meaningful variance. The inclusion of Q19 and Q21 were based on findings from the literature review that included measures that tapped into third-person perception (Ref. 17)— which is among the most widely replicated phenomena across media contents (Ref. 18), such as DTC prescription drug advertising (Ref. 19). By including an item that taps into third-person effects, we will be able to explore if consumers are more likely to think that others will be misled, even if they do not think they are susceptible to being misled by the website. x. Question Q24 of Study 1 should be one of the first questions of the survey. A subject will likely answer this question most accurately immediately after reviewing the website and before answering other questions that could influence this answer. (Response) To avoid bias, the most critical questions should appear as up front as possible in the surveys. Although current question ordering may bias responses to the attention item, this outcome is less consequential and we chose instead to prioritize the key dependent variables (putting those measures that rely on memory at the start of the survey). Consequently, we intend to retain the current order of questions in the survey. y. The box for Question Q30 of Study 1 prompts the subject to respond, even if the individual did not select anything in the website as false or misleading. FDA should consider using a tiered response: Q30a: Did you notice anything on the website that is false or misleading? 1. Yes (go to question 30b). E:\FR\FM\12DEN1.SGM 12DEN1 ethrower on DSK3G9T082PROD with NOTICES Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices 2. No (go to question 31). Q30b: What information was false or misleading? [open box comment] (Response) A programming note was missing in the original survey draft. The current survey programming reflects the approach suggested by the commenter. z. The commenter recommends revising Question Q32 of Study 1 to: ‘‘If there was a way to report misleading prescription drug websites or ads to the Food and Drug Administration (FDA) by sending an email or calling a toll-free phone number, how likely would you report misleading material?’’ (Response) We have adopted this recommendation in the revised survey. aa. As previously stated in footnote 21, Questions Q34, Q41, and Q42 of Study 1 should be deleted. Footnote 21 reads: For example, FDA completed a HCP study incorporating information asked at Q34, Q41, and Q42 of Study 1. It is not clear why the Agency is undertaking another study focusing on such questions. These questions should be eliminated. (Response) Please see our response to Comment 3d. bb. Question S1 of Study 2 should be rewritten as follows: ‘‘Have you ever been diagnosed with obesity, defined as body mass index greater than or equal to 30?’’ This change aligns the question with the description of the study in the PRA Notice: ‘‘Study 2 will sample consumers diagnosed with obesity. . . .’’ (Response) For this study, our intent was to target people that would be in the audience for these ads, and being diagnosed is not a requirement for personal relevance. The target audience is consumers with a body mass index greater than or equal to 30. cc. The ‘‘Debriefing’’ does not accurately portray the purpose of the studies. The purpose of the studies is not ‘‘to learn about how people feel about information provided in prescription drug websites aimed at consumers/providers and how people use this information to understand how well prescription drugs work.’’ The commenter recommends that the ‘‘Debriefing’’ read: ‘‘The purpose of this study is to investigate the ability of consumers/providers to identify false or misleading prescription drug promotion and how likely consumers/providers are to report false or misleading prescription drug promotion to regulatory authorities.’’ (Response) We have adopted this recommendation. (Comment 4) regulations.gov tracking number 1k1–8v3r–jacf (summarized for brevity): VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 a. The commenter expressed concern about the practical utility of the consumer-oriented arms of the research. Namely, if consumers are unfamiliar with the prescribing information for the product, it is unclear on which basis they can determine a claim to be deceptive. (Response) Please see our response to Comment 3f, which addresses a similar theme and may provide useful context. The concern addressed by the commenter is framed as a limitation of the study and appears to question the relevance of examining consumers’ ability to detect deception in prescription drug promotion. We believe the opposite is correct: The merit of conducting the study is reinforced by the observation that it is unclear how consumers can determine a claim to be deceptive if they lack relevant background information or knowledge about an advertised drug. While prescription drug promotions are required to present truthful and nonmisleading information, some prescription drug promotion nevertheless includes false or misleading claims, images, or presentations. DTC prescription drug promotion can help provide consumers with truthful information about drugs. When it does so, it can help consumers to make well-informed decisions when determining whether to explore treatment options and when making ultimate treatment choices, and it can provide useful and actionable information about a product’s efficacy and risks to consumers already on treatment, among other outcomes. Yet, because the information in prescription drug promotion is not always truthful, consumers must make judgments about whether it is true, misleading, or false. And the same background knowledge that a consumer might rely on to identify a claim as deceptive would also be used to decide that a claim is true. As the commenter points out, this background information may be incomplete or inadequate for the task, and yet some presume that consumers (and, for that matter, healthcare providers) are typically able to distinguish between true claims and those that are false or misleading. Concerns like the one voiced here and the empirical literature on the topic suggest there is reason to doubt this presumption, thus warranting the proposed study. b. The commenter expressed concern that the varied causes of obesity will result in a heterogeneous population which could potentially confound the results of the study. PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 58419 (Response) We consider diversity within this illness population to be an asset. Also, random assignment will help to control extraneous influences because it will create groups that, on average, are probabilistically similar to each other. Because randomization eliminates most other sources of systematic variation, researchers can be reasonably confident that any effect that is found is the result of the intervention and not some preexisting differences between the groups (Ref. 20). Consequently, the varied causes of obesity should not impact the results. The primary intention of the research is to empirically examine consumer and HCP ability to detect and report deceptive prescription drug promotion, but we have to choose stimuli (and by extension, an illness population) in order to empirically test our research questions. By choosing illness conditions with diverse patient populations, we can better grasp how consumers and HCPs from all walks of life react to deceptive prescription drug promotion. Also see response to comment 3j. (Comment 5) regulations.gov tracking number 1k1–8v3v–v60p (verbatim with header and footer language, introductory language, and supporting references removed): We strongly support FDA’s proposed project as part of the Agency’s broader research efforts to better understand the impact of prescription drug promotion and direct-to-consumer advertising (DTC). Research regarding deceptive advertising is becoming increasingly important as DTC continues to grow at unprecedented rates. One analysis estimated DTC spending in 2015 at $5.2 billion—a growth of over 60 percent in just 4 years. Five drugs—HUMIRA, LYRICA, ELIQUIS, CIALIS, and XELJANZ—accounted for one-quarter of this $5.2 billion. Importantly, these figures are an underestimate, as they do not account for spending on digital ads and social media. The risks and benefits of DTC have been well noted and debated. DTC may promote patient dialogue with healthcare providers and remove the stigma associated with certain diseases. However, there are also significant concerns that DTC may be misleading, overemphasize a drug’s benefits as compared to risks, and lead to inappropriate prescribing and overutilization. Again, we applaud the FDA’s efforts in this important area. The need to better understand the ability of consumers and healthcare professionals to detect and report misleading DTC is critical as the use of DTC continues to E:\FR\FM\12DEN1.SGM 12DEN1 58420 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices grow. Thank you for the opportunity to provide these comments. (Response) FDA appreciates this support. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Pilot study screener completes Number of responses per respondent 4,286 (chronic pain) ................ 714 (obesity) 612 (HCP) Total annual responses Average burden per response Total hours 1 5,612 0.03 (2 minutes) ............... 187 1 14,031 0.03 (2 minutes) ............... 468 1 600 0.33 (20 minutes) ............. 200 1 1,500 0.33 (20 minutes) ............. 500 ........................ ........................ ........................................... 1,355 5,612 total Main study screener completes. 10,714 (chronic pain) .............. 1,786 (obesity) 1,531 (HCP) 14,031 total Pilot study completes .............. 150 (chronic pain) ................... 150 (obesity) 300 (HCP) 600 total Main study completes ............. 375 (chronic pain) ................... 375 (obesity) 750 (HCP) 1,500 total Total ................................. 1 There ................................................. are no capital costs or operating and maintenance costs associated with this collection of information. III. References ethrower on DSK3G9T082PROD with NOTICES The following references are on display in the Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 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 https:// www.regulations.gov. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Faerber, A.E. and D.H. Kreling. ‘‘Content Analysis of False and Misleading Claims in Television Advertising for Prescription and Nonprescription Drugs.’’ Journal of General Internal Medicine, 29(1): 110–118, 2014. 2. Symonds, T., C. Hackford, and L. Abraham. ‘‘A Review of FDA Warning Letters and Notices of Violation Issued for Patient-Reported Outcomes Promotional Claims Between 2006 and 2012.’’ Value in Health, 17: 433–437, 2014. 3. Mitra, A., M.A. Raymond, and C.D. Hopkins. ‘‘Can Consumers Recognize Misleading Advertising Content in a Media Rich Online Environment?’’ Psychology & Marketing, 25(7): 655–674, 2008. 4. Hastak, M. and M.B. Mazis. ‘‘Deception by Implication: A Typology of Truthful but VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 Misleading Advertising and Labeling Claims.’’ Journal of Public Policy & Marketing, 30(2): 157–167, 2011. 5. O’Donoghue, A.C., V. Boudewyns, K.J. Aikin, E. Geisen, et al. ‘‘Awareness of the FDA’s Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings.’’ Journal of Health Communication, 20: 1330–1336, 2015. 6. Nahin, R.L. ‘‘Estimates of Pain Prevalence and Severity in Adults: United States, 2012.’’ Journal of Pain, 16(8): 769–780, 2015. 7. U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics. ‘‘Healthy Weight, Overweight, and Obesity Among Adults Aged 20 and Over, by Selected Characteristics: United States, Selected Years 1988–1994 Through 2009–2012 [Table].’’ In Health, United States, 2014 with special feature on adults aged 55–64 (pp. 214220; DHHS Publication No. 2015–1232). Retrieved from http://www.cdc.gov/nchs/data/hus/ hus14.pdf. 8. Krosnick, J.A. and S. Presser. ‘‘Question and Questionnaire Design.’’ In: Handbook of Survey Research (pp. 263– 314). Bingley, United Kingdom: Emerald Group Publishing Limited, 2010. 9. Converse, J.M. and, S. Presser. Survey Questions: Handcrafting the Standardized Questionnaire (No. 63). Thousand Oaks, CA: SAGE Publications, 1986. 10. DeVellis, R.F. Scale Development: Theory PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 and Applications (Vol. 26). Thousand Oaks, CA: SAGE Publications, 2016. 11. Sullivan, H.W., K.J. Aikin, E. ChungDavies, and M. Wade. ‘‘Prescription Drug Promotion from 2001–2014: Data from the U.S. Food and Drug Administration.’’ PLoS ONE, http://dx.doi.org/10.1371/ journal.pone.0155035, 2016. 12. Liang, B.A. and T.K. Mackey. ‘‘Prevalence and Global Health Implications of Social Media in Direct-to-Consumer Drug Advertising.’’ Journal of Medical Internet Research, 13(3), e64, 2011. 13. Southwell, B.G. and D.J. Rupert. ‘‘Future Challenges and Opportunities in Online Prescription Drug Promotion Research.’’ International Journal of Health Policy and Management, 5(3), 211–213, 2016. 14. Davis, J.J., E. Cross, and J. Crowley. ‘‘Pharmaceutical Web Sites and the Communication of Risk Information.’’ Journal of Health Communication, 12, 29–39, 2007. 15. Singleton, Jr., R.A., B.C. Straits, and M.M. Straits. Approaches to Social Research. Oxford, United Kingdom: Oxford University Press, 1993. 16. Aday, L.A. and L.J. Cornelius. Designing and Conducting Health Surveys: A Comprehensive Guide. Hoboken, NJ: John Wiley & Sons, 2006. 17. Xie, G.X. ‘‘Deceptive Advertising and Third-Person Perception: The Interplay of Generalized and Specific Suspicion.’’ Journal of Marketing Communications, 22(5), 494–512. doi:10.1080/ 13527266.2014.918051, 2014. 18. Sun, Y., Z. Pan, and L. Shen. ‘‘Understanding the Third-Person E:\FR\FM\12DEN1.SGM 12DEN1 Federal Register / Vol. 82, No. 237 / Tuesday, December 12, 2017 / Notices Perception: Evidence from a MetaAnalysis.’’ Journal of Communication, 58(2), 280–300, 2008. 19. DeLorme, D.E., J. Huh, and L.N. Reid. ‘‘Perceived Effects of Direct-ToConsumer (DTC) Prescription Drug Advertising on Self and Others.’’ Journal of Advertising, 35(3), 47–65, 2006. 20. Fisher, R.A. The Design of Experiments. Edinburgh, United Kingdom: Oliver and Boyd, 1937. Dated: December 6, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26704 Filed 12–11–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2017–P–2659] Determination That NOROXIN (Norfloxacin) Tablets, 400 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) has determined that NOROXIN (norfloxacin) tablets, 400 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for norfloxacin tablets, 400 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Darren Eicken, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6206, Silver Spring, MD 20993–0002, 240– 402–0978. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98–417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ‘‘listed drug,’’ which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to ethrower on DSK3G9T082PROD with NOTICES SUMMARY: VerDate Sep<11>2014 20:03 Dec 11, 2017 Jkt 244001 gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ‘‘Approved Drug Products With Therapeutic Equivalence Evaluations,’’ which is known generally as the ‘‘Orange Book.’’ Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug’s NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. NOROXIN (norfloxacin) tablets, 400 mg, is the subject of NDA 019384, held by Merck & Company, Inc. (Merck), and initially approved on October 31, 1986. NOROXIN is indicated for the treatment of adults with the following infections caused by susceptible strains of certain designated microorganisms: Uncomplicated urinary tract infections (including cystitis), uncomplicated urethral and cervical gonorrhea, and prostatitis. In a letter dated October 13, 2015, Merck notified FDA that NOROXIN (norfloxacin) tablets, 400 mg, was being discontinued, and FDA moved the drug product to the ‘‘Discontinued Drug Product List’’ section of the Orange Book. In the Federal Register of October 4, 2016 (81 FR 68427), FDA announced that it was withdrawing approval of NDA 019384, effective November 3, 2016. Jubilant Generics Ltd. submitted a citizen petition dated April 27, 2017 (Docket No. FDA–2017–P–2659), under 21 CFR 10.30, requesting that the Agency determine whether NOROXIN (norfloxacin) tablets, 400 mg, was withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that NOROXIN (norfloxacin) tablets, 400 mg, was not withdrawn for reasons of safety or effectiveness. The PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 58421 petitioner has identified no data or other information suggesting that NOROXIN (norfloxacin) tablets, 400 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of NOROXIN (norfloxacin) tablets, 400 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list NOROXIN (norfloxacin) tablets, 400 mg, in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to NOROXIN (norfloxacin) tablets, 400 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised, the Agency will advise ANDA applicants to submit such labeling. Dated: December 6, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017–26693 Filed 12–11–17; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–1999–D–4079] Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ‘‘Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements.’’ The guidance clarifies the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertisements for human prescription drugs, including prescription biological products, and for animal prescription SUMMARY: E:\FR\FM\12DEN1.SGM 12DEN1

Agencies

[Federal Register Volume 82, Number 237 (Tuesday, December 12, 2017)]
[Notices]
[Pages 58411-58421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-26704]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4487]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Consumer and 
Healthcare Professional Identification of and Responses to Deceptive 
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by January 
11, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910--New and 
title ``Consumer and Healthcare Professional Identification of and 
Responses to Deceptive Prescription Drug Promotion.'' Also include the 
FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

[[Page 58412]]

Consumer and Healthcare Professional Identification of and Responses to 
Deceptive Prescription Drug Promotion

OMB Control Number 0910--NEW

I. Background
    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 
300u(a)(4)) authorizes FDA to conduct research relating to health 
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and 
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to 
conduct research relating to drugs and other FDA regulated products in 
carrying out the provisions of the FD&C Act. Under the FD&C Act and 
implementing regulations, promotional labeling and advertising about 
prescription drugs are generally required to be truthful, non-
misleading, and to reveal facts material to the presentations made 
about the product being promoted (see FD&C Act sections 201(n) and 
502(a) and (n) (21 U.S.C. 321(n) and 352(a) and (n)); see also 21 CFR 
202.1).
    Prescription drug promotion sometimes includes false or misleading 
(collectively, deceptive \1\) claims, images, or other presentations; 
for instance, representations that a drug is more effective or less 
risky than is demonstrated by appropriate evidence. A number of 
empirical studies have examined the occurrence and influence of 
deceptive promotion, both in regard to prescription drugs (Refs. 1 and 
2) and other products (Refs. 3 and 4). No research to our knowledge, 
however, has investigated the ability of consumers and healthcare 
professionals (HCPs) to independently identify deceptive prescription 
drug promotion.
---------------------------------------------------------------------------

    \1\ Our use of the term deceptive is not meant to imply 
equivalence (or lack thereof) with use of the same term by the U.S. 
Federal Trade Commission. As used in this document, this term refers 
to presentations that are considered false or misleading within the 
context of prescription drug promotion.
---------------------------------------------------------------------------

    The ability of consumers and HCPs to identify deceptive 
prescription drug promotion has important public health implications. 
If unable to identify deceptive promotion, consumers may ask their HCPs 
to prescribe specific drugs that they would not otherwise request. 
Likewise, HCPs who are unable to identify deceptive promotion may 
prescribe specific drugs that they would not otherwise prescribe. On 
the other hand, if consumers and HCPs are able to identify deceptive 
promotion, they may appropriately discount or disregard such 
information in their medication decisions, and perhaps even report 
deceptive promotion to appropriate government regulators who can take 
corrective action.
    Reports of deceptive promotion are useful to FDA because they allow 
investigators to focus their efforts in an era where the amount of 
promotion far exceeds the resources available to review everything. The 
FDA Bad Ad program, for example, encourages HCPs to report deceptive 
prescription drug promotion (Ref. 5), a goal which requires that HCPs 
successfully identify such promotion when it appears in the course of 
their duties. Likewise, similar programs could be implemented for 
consumers to report deceptive prescription drug promotion to FDA.
    The mission of the Office of Prescription Drug Promotion (OPDP) 
within FDA is to protect the public health by helping to ensure that 
prescription drug promotion is truthful, balanced, and accurately 
communicated, and to guard against deceptive promotion through 
comprehensive surveillance, enforcement, and educational programs. As 
part of this mission, it is critical that OPDP adequately understand 
the capacity of consumers and HCPs to detect false and misleading 
claims as well as these populations' processing of such claims. This 
understanding will help OPDP to identify best practices for addressing 
false and misleading claims in prescription drug promotion. The 
research described here will provide evidence to inform consideration 
of the approaches best suited to fulfill OPDP's mission to protect the 
public from deceptive promotion.
    The proposed project involves two studies examining volunteer 
participants' ability to detect and report deceptive presentations in 
prescription drug promotion. The studies will be conducted concurrently 
and will focus on different health conditions. Each study will be 
administered to two separate populations (i.e., HCPs and consumers 
affected by the condition). HCPs will view mock pharmaceutical websites 
targeted toward physicians and consumers will view mock consumer-
targeted pharmaceutical websites. The goal will be to keep the HCP and 
consumer-targeted websites as similar as possible, but to include 
content that is appropriate for the target audience. For example, HCP 
websites may contain medical terminology, whereas the consumer websites 
would utilize consumer friendly language. A professional firm will 
create all mock websites such that they are generally indistinguishable 
from currently available prescription drug websites.
II. Study 1 and 2
    Study 1 and 2 sample. Study 1 will sample consumers who self-report 
chronic pain that has lasted at least 3 months and HCPs whose primary 
medical specialty is either primary care or internal medicine and whose 
responsibilities involve direct patient care at least 50 percent of the 
time. Chronic pain has an incidence rate of roughly 11 percent (Ref. 6) 
in the population. Study 2 will sample consumers who self-report 
obesity, defined as body mass index greater than or equal to 30 (35 
percent incidence; Ref. 7) and include the same types of HCPs as study 
1. For both consumers and HCPs, pretest participants will not be 
eligible for the main study.
    Pretesting. Pretesting will take place before the main studies to 
evaluate the procedures and measures used in the main studies. Each of 
the two pretests will have the same design as its respective main study 
(pretest 1 for Study 1 and pretest 2 for Study 2). The purpose of both 
pretests will be to: (1) Ensure that the mock websites are 
understandable, viewable, and delivering intended messages; (2) 
identify and eliminate any challenges to embedding the mock websites 
within the online survey; (3) ensure that survey questions are 
appropriate and meet the analytical goals of the research; and (4) 
pilot test the methods, including examining response rates and timing 
of survey. The two pretests will be conducted simultaneously. Based on 
pretest findings, we will refine the mock websites, survey questions, 
and data collection process, as necessary, to optimize the full-scale 
study conditions.
    Main studies. The proposed design for the main studies, including 
sample sizes, is summarized below and described next.

[[Page 58413]]



                      Study 1--Degree of Deception Based on the Number of Deceptive Claims
----------------------------------------------------------------------------------------------------------------
                                                                      Experimental condition
                                                 ---------------------------------------------------------------
                   Population                          None            Fewer           More
                                                     (control)      violations      violations         Total
----------------------------------------------------------------------------------------------------------------
HCPs............................................             125             125             125             375
Consumers w/chronic pain........................             125             125             125             375
----------------------------------------------------------------------------------------------------------------


                        Study 2--Type of Deception Based on Implicit and Explicit Claims
----------------------------------------------------------------------------------------------------------------
                                                                      Experimental condition
                                                 ---------------------------------------------------------------
                   Population                          None
                                                     (control)       Implicit        Explicit          Total
----------------------------------------------------------------------------------------------------------------
HCPs............................................             125             125             125             375
Obese consumers.................................             125             125             125             375
----------------------------------------------------------------------------------------------------------------

    The purpose of Study 1 is to assess consumer and HCP response to 
promotional websites with varying levels of false or misleading 
presentations. In Study 1, degree of deception will be manipulated over 
three levels by altering the number of deceptive claims (none, fewer, 
more). It is possible that consumers and HCPs are only able to identify 
ads as deceptive when they include a greater number of violations, 
whereas ads with few violations may not be identified as deceptive. The 
experimental stimuli will be in the form of a web page for a fictitious 
drug targeted toward consumers who have chronic pain or toward HCPs. 
The deceptive websites will contain various types of violations. The 
website with fewer violations will contain a subset of the deceptive 
claims, imagery, or other presentations included in the website with 
more violations. For example, if the fewer-violations website includes 
two violations, then the more-violations website will include the same 
two violations plus two or three additional violations (in the form of 
claims and/or graphics).
    Study 1 will help FDA address several key questions:
     What proportion of consumers and HCPs correctly identify a 
promotional piece as deceptive? Does the ability to identify deceptive 
promotion vary depending on the number of deceptive claims in a 
promotional piece?
     Does the degree of deception affect consumers' and HCPs' 
attitudes and behavioral intentions toward the promoted drug, including 
intended reporting to regulatory authorities?
     Is the effect of deceptive promotional pieces mediated by 
a person's ability to identify a promotional piece as deceptive (that 
is, do people who recognize a piece as deceptive discount the 
information in the piece, thereby adjusting their attitudes and 
intentions toward the product)?
    Whereas Study 1 focuses on the level of deception (based solely on 
the number of false or misleading claims), Study 2 focuses on the type 
of deception (implicit versus explicit). Many deceptive promotional 
claims are implicit rather than being explicitly false (Refs. 1 and 4). 
An implicit claim suggests or implies an unstated piece of information. 
An explicit claim fully and clearly expresses information and leaves 
nothing to be implied. Study 2 will compare perceptions and beliefs 
that consumers and HCPs hold about a drug following exposure to one of 
three versions of a prescription drug website: (1) An explicitly false 
website, (2) a factually true but implicitly misleading website, or (3) 
a website with no deceptive claims (the control group).
    As with Study 1, we envision a pair of one-way factorial 
experiments, one conducted with a sample of consumers and the other 
with HCPs. Similar to Study 1, Study 2 will investigate how misleading 
implicit claims and explicitly false claims in prescription drug 
promotional pieces influence a person's ability to detect and respond 
appropriately to deception. The experimental stimuli will be in the 
form of a mockup of a pharmaceutical website targeted toward the 
relevant experimental population, obese consumers or HCPs who treat 
obese patients. As with study 1, the drug profile, including 
indication, risks, and logo branding will be fictitious. For the 
implicit misleading claim manipulations, we are interested in whether 
people infer false beliefs from the implicit communications.
    Study 2 will help FDA address several key questions:
     What proportion of consumers and HCPs correctly identify a 
promotional piece as deceptive? Does the ability to identify deceptive 
promotion vary depending on whether deceptive claims in a promotional 
piece are explicit versus implicit?
     Does the type of deception affect consumers' and HCPs' 
attitudes and behavioral intentions toward the promoted drug, including 
intended reporting to regulatory authorities?
     Is the effect of deceptive promotional pieces mediated by 
a person's ability to identify a promotional piece as deceptive (that 
is, do people who recognize a piece as deceptive discount the 
information in the piece, thereby adjusting their attitudes and 
intentions toward the product)?
    Measurement. Identifying how to measure consumers' and HCPs' 
ability to identify deceptive promotion as well as their reaction to 
such promotion is fundamental to achieving the research goals. A 
literature review revealed the importance of using a variety of 
measures to capture detection of deception. For direct measures, we 
will incorporate questions that ask participants to indicate whether 
there was any deception in the promotional piece and to rate the 
promotional piece in terms of how deceptive, credible, or trustworthy 
it was. Additionally, we will include claim-specific direct measures 
that allow people to click on any part of the website that they deem 
deceptive. Using responses to this variable, we can assess whether 
participants think there is any deception in a promotional piece; in 
instances where they do think there is deception, we can assess what 
aspects of the website contributed to that belief. We will also include 
indirect measures that identify whether participants believed the 
website expressed particular claims (e.g., claim recognition) as well 
as participants' beliefs about the veracity of any deceptive claims 
(e.g., claim

[[Page 58414]]

truth, agreement, or acceptance). Moreover, we will assess whether 
participants believe the messages merit reporting to regulatory 
authorities (that is, FDA). To examine differences between experimental 
conditions, we will conduct inferential statistical tests such as 
analysis of variance. A copy of the draft questionnaire is available 
upon request.
    In the Federal Register of January 4, 2017 (82 FR 855), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Comments received along with our responses 
to the comments are provided below. Comments that are not PRA-relevant 
or do not relate to the proposed study are not included. For brevity, 
some public comments are paraphrased and therefore may not reflect the 
exact language used by the commenter. We assure commenters that the 
entirety of their comments was considered even if not fully captured by 
our paraphrasing. Question numbering here (e.g., Q30) reflects 
numbering from the original draft questionnaire, shared by request at 
the time of the 60-day notice. The following acronyms are used here: 
FRN = Federal Register Notice; DTC = direct-to-consumer; HCP = 
healthcare professional; FDA and ``The Agency'' = Food and Drug 
Administration; OPDP = FDA's Office of Prescription Drug Promotion.
    (Comment 1) regulations.gov tracking number 1k1-8ubr-t0de (verbatim 
with header and footer language removed):
    We are supportive of the study, but have the following 
recommendations.
    We propose that additional study arms be included that explore 
various scenarios/websites which test both the number of deceptive 
claims in conjunction with the degree of deception. Currently, the 
study is structured to measure the impact of the number of deceptions 
in a promotional website (Study 1) separately from the degree of the 
deception (explicit vs implicit, in Study 2). However, it would also be 
beneficial to measure other combinations to see which factor or 
combination of factors had the greatest impact on HCPs and Consumers' 
overall perception of the website. For example, a single explicit lie 
may be more impactful than 15 implied deceptions. The current study 
will not be able to draw any conclusions regarding that scenario. 
Testing additional combinations of the number of deceptions in a 
website along with deceptive claims of varying severity would enable a 
better comparison and understanding of what ultimately drives HCPs and 
Consumers' perception of deceptive prescription promotion.
    (Response) We thank the commenter for their support and for this 
suggestion. While certainly a viable research idea, cost implications 
of creating and testing additional stimuli for this purpose bar us from 
pursuing it. We encourage researchers to pursue this idea in future 
research.
    (Comment 2) regulations.gov tracking number 1k1-8v15-11b6 (some 
comments summarized for brevity; others provided verbatim):
    a. Given the stated purpose of the pretests, sample size can be 
substantially reduced, and revised to a qualitative approach.
    (Response) In addition to the quantitative pretest, we have already 
conducted a qualitative test of stimuli and questionnaire materials via 
cognitive interviews. Changes based on cognitive interviews are 
reflected in our updated survey materials. In regard to sample size, 
the number of pretest participants per experimental condition (n = 50) 
was chosen based on a power analysis, and is considered to be the 
minimum effective size to allow for assessment of the quantitative 
outcomes specified in the 60-day FRN. Examples of quantitative outcomes 
include assessment of response rates and timing of the survey.
    b. To reduce bias, add a screening question to exclude respondents 
who are opposed to taking prescription medicines.
    (Response) The survey length does not allow for a full exploration 
of attitudes toward prescription drug use. However, to assess 
opposition to prescription drug use more generally, we added one item 
to the survey that has been used successfully in previous FDA surveys. 
This item will be used in the pretest survey as a potential covariate 
and may or may not be retained in the main study survey depending on 
its performance.
    The item reads: ``In what situations would you consider taking 
prescription drugs?''
     I would never take them.
     I would take them only for serious health conditions.
     I would take them for moderate and serious health 
conditions.
     I would take them for most health conditions, including 
minor problems.
    c. Consider revising item scales to include a mid-point to allow 
respondents to express neutral views (unless objective is to force a 
selection).
    (Response) Given the focus of the questions, we believe that 
offering a neutral response option is not necessary to measure opinions 
and attitudes accurately. Consequently, our objective is to force a 
selection and have participants make at least a weak commitment in 
either a positive or negative direction. Of concern is that offering a 
neutral midpoint could potentially encourage ``satisficing''--cuing 
participants to choose a neutral response because it is offered (Ref. 
8). Additionally, providing a midpoint leads to the loss of information 
regarding the direction in which people lean (Ref. 9). Research has 
found that neither format (either with or without a neutral point) is 
necessarily better or produces more valid or reliable results (Ref. 
10). Instead, it should be left to the researcher to determine the 
goals of the study. During cognitive testing, a majority of 
participants were satisfied with the response options and all 
participants felt comfortable choosing a response in the absence of a 
midpoint. Use of a midpoint is an issue we have examined in previous 
studies and we determined that we achieve valid and reliable responses 
without a midpoint. To increase consistency with measures used in 
previous studies, and in support of the arguments presented above, we 
are opting to exclude a midpoint. Finally, if a participant does not 
feel that they can choose a response because of a lack of a neutral 
option, they will be able to skip the question.
    d. In Study 1, remove Q21 and Q30 due to potentially leading nature 
of items.
    (Response) To avoid redundancy, we dropped Q21. In Q30, we ask 
participants to click on anything they think is misleading, and we note 
that if they do not think anything is misleading, they can click 
``none.'' Consequently, we are not strongly presupposing there are 
misleading claims. To address some of the wording concerns for this 
item, we changed the question to ask about inaccurate information 
instead of misleading information and we moved the ``None'' response to 
be more prominent above the image.
    (Comment 3) regulations.gov tracking number 1k1-8v3z-nzst 
(summarized for brevity):
    The commenter expresses concern about the practical utility of the 
research, reasons for which are covered by comments 3a through 3e. In 
the case that FDA continues with the research, the commenter makes 
several recommendations which are covered by comments 3f through 3cc. 
Comments 3f through 3h concern the study stimuli, comment 3i pertains 
to subject recruitment, and comments 3j through 3cc concern the study 
questionnaires.
    a. The identification of deceptive promotion is FDA's assigned

[[Page 58415]]

responsibility, not the duty of HCPs and consumers.
    (Response) As discussed above, the mission of OPDP within FDA is to 
protect the public health by helping to ensure that prescription drug 
promotion is truthful, balanced, and accurately communicated, and to 
guard against false and misleading promotion through comprehensive 
surveillance, enforcement, and educational programs. As part of this 
mission, it is critical that OPDP adequately understand the capacity of 
consumers and HCPs to detect false and misleading claims as well as 
these populations' processing of such claims. This understanding will 
help FDA/OPDP to identify best practices for addressing deceptive 
claims in prescription drug promotion. Moreover, we note that sponsors 
are not generally required to submit promotional pieces to FDA prior to 
dissemination, and limited resources prevent OPDP from reviewing all 
promotional materials in the marketplace. Voluntary HCP and consumer 
reporting of false and misleading promotional pieces contribute to the 
accomplishment of FDA/OPDP's mission.
    b. Deceptive drug promotion is not a prevalent issue that requires 
further studying.
    (Response) Numerous studies have examined the prevalence of false 
or misleading claims and presentations in DTC advertising, and FDA 
frequently issues compliance letters addressing false and misleading 
claims and presentations (Refs. 1 and 2). Consequently, FDA disagrees 
with this assertion.
    c. FDA's proposed studies fail to acknowledge the role of the HCP 
as the ``learned intermediary.''
    (Response) The present research takes into consideration both 
consumer and HCP responses to false or misleading promotion. Consumers 
often wish to participate in shared decision making with HCPs when 
selecting prescription drugs and may request specific prescription 
drugs from their HCPs based on promotions they have seen in the 
marketplace. Because information consumers receive through DTC 
prescription drug promotion can impact these requests, it is important 
to investigate consumers' ability to assess prescription drug product 
efficacy and risks as conveyed in promotional pieces. And although HCPs 
have medical training and clinical expertise, we are not aware of 
research that investigates whether such training and expertise 
translates into an ability to detect false or misleading promotion in 
the marketplace. Consequently, the present research investigates both 
consumer and HCP ability to identify and discount deceptive 
prescription drug promotion.
    d. The proposed studies are duplicative of recent FDA research 
concerning HCP willingness to report deceptive promotion.
    The commenter suggests that if FDA wishes to investigate consumer 
reporting, the Agency should create two separate studies. The first 
should gauge consumer aptitude in identifying false or misleading 
prescription drug promotion. Depending on the results of the first 
study, the Agency could potentially undertake a second study, surveying 
subject willingness to report false or misleading drug promotion. This 
approach would avoid potential error associated with influence of 
earlier questions regarding deception on later questions regarding 
reporting.
    (Response) FDA conducted a survey of HCPs in 2013 in which 
respondents were asked about their familiarity with the Bad Ad program 
and willingness to report misleading advertising (Ref. 5). The current 
study is quite different in scope from the previous research. The 
current study consists of an experimental design that will enable us to 
determine whether HCPs can detect misleading advertising, not just 
whether they are willing to report it. We do include questions at the 
end of the survey asking similar questions as those in the 2013 survey, 
but the purpose here is in connection to HCP ability to detect 
misleading advertising. Moreover, our use of similar questions here 
reflects a well-established technique in scientific research, used to 
determine whether previous findings can be replicated or not.
    In response to the second comment recommending division of this 
project into two separate studies, we believe that proposal to be an 
inefficient use of resources. Regarding concerns about the order of 
questions affecting subsequent responses, we chose to distribute 
deception-related items throughout the survey, rather than ask all 
deception items first and then other outcome measures second. Also, we 
include ``masking'' items on the same screen as deception-related items 
to mask the intent of the questions. The results from cognitive 
interviews confirm that this approach was successful. Consequently, we 
have no evidence to suggest that earlier questions related to deception 
will influence subsequent questions related to reporting.
    e. FDA already has created and implemented consumer programs to 
report deceptive promotion.
    (Response) The proposed research can inform program needs at 
present, whether such needs involve reevaluation of past programs such 
as EthicAd, or extensions of existing programs such as the Bad Ad 
program or other actions.
    f. Validating Stimuli. It is not clear how the Agency will 
determine that a study stimulus is deceptive. FDA notes in the PRA 
Notice that the ``term deceptive is not meant to imply equivalence (or 
lack thereof) with use of the same term by the U.S. Federal Trade 
Commission.'' It seems unrealistic for FDA to conduct research with 
primary care physicians (PCPs) and consumers who do not understand the 
Agency's standards or have access to the training and resources of an 
FDA reviewer.
    Further, except for literal falsity, whether a particular 
communication is false or misleading must be based on empirical 
evidence. Promotional pieces do not exist in a vacuum. These 
communications interact with the overall health information ecosystem, 
including the internet. FDA needs to first validate that the study 
stimuli are indeed deceptive before including the stimuli in either 
proposed study with the presumption that they are deceptive.
    (Response) Our reference to the Federal Trade Commission's (FTC) 
definition of the term ``deceptive'' was offered as a point of 
clarification for our use of the same term as shorthand within the FRN 
for the longer phrase ``false or misleading.'' In other words, by using 
``deceptive'' as a term of art in this narrow context, we are not 
evoking the specific meaning and interpretation of the same term used 
by the FTC.
    We disagree with the suggestion that participants need to have 
access to the training and resources of an FDA reviewer before FDA can 
evaluate their ability to identify deceptive promotion. As further 
explained below, FDA is not asking participants to determine whether 
nuanced text meets the regulatory standards for deceptive promotion; 
instead, we are presenting material that meets both the regulatory 
standard for a deceptive promotion and could be identified as such by 
consumers or healthcare providers with no prior experience with the 
regulations.
    We agree with the second point about the need to validate that the 
study stimuli are deceptive, and we are doing this in several ways for 
this study. For example, some of the specific claims used in our 
experimental manipulations are established as being factually incorrect 
because the promoted drug is a member of a class of drugs for which the 
claim could not be true (e.g., describing a serotonin-norepinephrine 
reuptake inhibitor (SNRI), which is

[[Page 58416]]

required to have a black box safety warning for suicide risk, as 
lacking in significant safety concerns). Other claims or presentations 
in the stimuli are based on similar claims cited as violative in past 
warning letters or that unambiguously fail to follow the law (e.g., 
minimizing presentation of important safety information, such as a 
black box warning, by setting it in small, low contrast type). For one 
manipulated claim, we provided participants with access to the 
background information needed to identify the presentation as deceptive 
in the form of a footnote. In the case of Study 2, where a crucial 
aspect of the experimental design is to test an implicitly misleading 
claim in relation to an explicitly false claim and against a 
nonviolative control, we tested candidate claims in cognitive 
interviews to verify that the audience tended to interpret the implicit 
claims as intended.
    Further, it is important to note that we included a control 
condition in both studies, which will enable us to compare responses to 
a website that has no violations. The control conditions serve as a 
baseline for perceived deception, which will also allow us to examine 
how consumers and providers perceive websites with no violations.
    g. Media. The Agency proposes using websites as the only stimuli. 
FDA should consider testing additional non-electronic media, including 
DTC and HCP print promotional materials. The Agency should also base 
the promotional stimuli on realistic ``mock'' package insert (PI) 
documents. The commenter requests that FDA make available for public 
comment these materials.
    (Response) Previous research on DTC and HCP-directed prescription 
drug promotional materials has, to varying extents, included all 
available media formats, and assessment of outcomes using these formats 
has proven useful. We agree that investigating recognition of 
misleading prescription drug information in multiple formats--including 
print, television, web, and other modes--would be valuable. However, we 
also recognize that no single study can effectively examine all 
promotional formats or presentations, and we chose to focus on branded 
drug websites for several reasons. First, websites, while not 
necessarily more or less useful than any other format, are arguably 
quite prevalent and important in today's technological age where a 
large segment of the consumer population is connected to the internet 
and known to seek information regarding prescription drugs using the 
internet. For example, online promotion is the fastest growing category 
of DTC drug marketing, and branded websites account for the largest 
share of this category (Ref. 11). Second, almost all print and 
television ads for prescription drugs encourage viewers to visit 
branded websites for more information, making these sites an important 
extension of promotion in other formats (Ref. 12). Third, FDA has 
issued multiple warning and notice of violation letters for branded 
drug websites that incorrectly communicate information to visitors, 
suggesting that there may be a problem with a proportion of such sites 
presenting misleading information. Fourth, websites serve as a fairly 
newer format for promotion relative to television and print promotion, 
and by consequence warrant further study. There has been significantly 
less research on consumer and provider interpretation of branded drug 
websites than other promotional formats (Ref. 13), and the extant 
research suggests that some websites still do not present a fair 
balance of risk and benefit information (Ref. 14).
    Based on these considerations, we believe that focusing this study 
on branded drug websites will be the most effective use of FDA's 
limited resources. The fictitious websites included in this study were 
modeled on real products (including the package insert) to ensure 
realism and relevance.
    In response to the request to share stimuli, we generally do not 
share stimuli before the study has been conducted to avoid possible 
inadvertent publication and therefore contamination of the subject 
pool, which would compromise the research.
    h. Disease States. The Agency's two studies propose testing stimuli 
concerning chronic pain or obesity. The commenter suggests that FDA 
instead consider testing stimuli featuring a fictitious product for a 
disease state which involves more complex safety information. Such 
stimuli would be more reflective of the current healthcare environment, 
where product labeling is increasingly complex.
    (Response) The fictitious websites used in this research do include 
complex safety information, which reflect the risks for real chronic 
pain and obesity products in the marketplace. For example, one of the 
fictitious products includes a black box warning, and the other 
includes severe and complex safety information, such as potential drug 
interactions and contraindications.
    i. Study 1 Stimuli. In Study 1, the ``degree of deception will be 
manipulated over three levels by altering the number of deceptive 
claims (none, fewer, more).'' FDA states that the deceptive claims will 
include ``various types of violations.'' Under the potential design, 
the most egregious deceptive claim(s) might only be contained in the 
``more'' level. This could potentially skew study results, as subjects 
would be more likely to identify such egregious claims. FDA should 
develop a scale that is used to determine the egregiousness of the 
deception. The scale should include specific examples of egregiousness 
by category.
    (Response) Although some claims do not overlap between the ``fewer 
violations'' and ``more violations'' conditions, we strategically 
manipulated the stimuli so that one of the more ``egregiously'' 
deceptive claims (which appears in a callout bubble) is present in both 
conditions. There is also overlap in those two conditions for another 
manipulated element, where we minimized the prominence of the Important 
Safety Information. Additionally, we included an item (Q30) that would 
provide participants the opportunity to click on anything they think 
may be inaccurate. Using this question, we would expect that the more 
egregious claims will be chosen more often. In this way, this item 
would serve as a proxy measure of egregiousness. Further, our various 
questions that ask about perceived deceptiveness of the websites will 
provide an initial assessment of the degree of deception--with higher 
scores representing greater perceived deception. Because of space 
constraints on the survey, we are unable to ask participants to rate 
the egregiousness of the violative claims. Although we appreciate the 
value that developing a scale to determine the egregiousness of each of 
the deceptive claims would add, adopting this suggestion in the present 
research would be outside of the scope of this study and would have an 
impact on overall cost considerations.
    j. FDA proposes that the HCP samples for both studies will only 
include physician subjects. The commenter believes the samples should 
include other types of HCPs, including nurse practitioners, physician 
assistants, and pharmacists. As the Agency's recent research showed, 
``Nurse practitioners and physician assistants tended to see the [Bad 
Ad] program as more useful than [PCPs] and specialists. They also 
reported a greater likelihood of reporting false or misleading 
advertising in the future.'' Given these findings, it would be helpful 
also to investigate the ability of other HCPs independently to identify 
false or misleading promotion.

[[Page 58417]]

    Additionally, during the recruiting process, FDA should ensure 
enrollment of a diversity of subjects across demographic categories. 
Previous research indicates that certain demographic groups respond to 
drug promotion in different manners. Uneven representation within 
certain categories could potentially skew study results.
    (Response) FDA acknowledges and agrees with the assertion that 
including other types of HCPs in this research would provide value. 
Yet, sampling from these additional groups requires funding that may 
not be justified in this initial investigation of the topic area. 
Nonetheless, we do intend to strive for diversity in both our HCP and 
consumer samples. HCPs and consumers will vary in terms of age, race, 
and ethnicity, and consumers will additionally vary in terms of their 
education level.
    k. Leading Questions. The overall format of the questionnaires is 
quite leading. As previously mentioned, questions asking whether sample 
advertisements are ``deceptive,'' ``misleading,'' ``bad,'' and ``not 
believable'' could easily pollute data from later questions inquiring 
whether a subject would potentially report such promotion to FDA. The 
Agency should state all questions in an objective manner.
    (Response) Leading questions are those that ``suggest a possible 
answer or make some responses seem more acceptable than others'' (Ref. 
15). In keeping with standard practice for balancing the valence of 
attitudinal questions, we have included a mix of positive and negative 
statements in the questionnaire. In fact, there are presently more 
positively framed items than negatively framed items. Moreover, the 
slider questions referenced by the commenter are semantic 
differentials, which show both a negatively framed word and its 
positive counterpart on opposite ends of the response scale (e.g., 
``deceptive/truthful,'' ``misleading/accurate,'' ``not believable/
believable''). We do not see how these items could be construed as 
leading because both the positive and negative frames are presented. 
Finally, as stated in our response to Comment 3d, we have evidence to 
suggest that we successfully masked the true focus of the 
questionnaire, so the deception-focused items should not bias 
subsequent responses.
    l. Recall Questions. Certain questions (e.g., Q1-Q3 of Study 1, Q4 
of Study 2) ask test subjects to recall specific risks and side effects 
of the featured drug products. Such questions are not valid instruments 
to assess whether a subject perceives a stimulus to be false or 
misleading. Recall is likely influenced by the presentation of the 
content (e.g., size, visual display), not by the content itself. This 
research, however, is not material to the stated purpose of the 
studies. The recall questions should be omitted from the 
questionnaires.
    (Response) Q1-Q2 of Study 1 measure risk recall and risk 
recognition. These are important outcome measures for our study because 
we vary how the risks are presented in the different experimental 
conditions, minimizing them (in terms of size and format) in the 
violative conditions. Including these risk recall and recognition 
measures allow us to test whether minimizing the risks influences 
participants' ability to remember them. Further, because minimization 
of risk is a misleading violation in its own right, reduced risk recall 
or recognition among participants in the violative conditions would 
provide relevant context for interpreting more direct measures of 
deception. Q4 of Study 2 will enable us to determine if participants 
can recall seeing the disclosure statements in the websites. This is 
relevant to the question of whether participants identify false or 
misleading content because the disclosure statement provides 
information that would help participants assess the truth of the 
headline claim. None of these items are intended to be direct measures 
of whether the stimuli are misleading; instead, they are outcomes that 
may be affected by misleading content.
    m. Repetitive Questions. The questionnaires are repetitive in 
nature. For example, in Q4-Q11 of Study 1, subjects are asked a series 
of eight questions to measure ``Perceived Website Deception.'' The 
questions are redundant (e.g., Believable/Not believable, Truthful/
Deceptive, Factual/Distorted, Accurate/Misleading). This duplication 
may cause the subject to believe the promotional material is actually 
false or misleading.
    (Response) The use of multiple items to tap into a singular 
construct is considered a best practice in social science research, 
particularly when assessing complex psychological constructs like those 
in this survey. Our intent is to combine responses to these items into 
a single composite score. Our cognitive interviewing of these items 
suggests that they have slightly different meanings for many 
participants and thus are not viewed as completely redundant. Further, 
there is no evidence to suggest that the use of multiple items to 
assess this construct led participants to believe that the promotional 
material was actually false or misleading or that this series of 
questions was designed to capture whether they thought the website was 
misleading. Consequently, we successfully masked the true intent of 
this item by including other bipolar response options unrelated to 
misleadingness.
    We dropped Q21 to reduce redundancy across items.
    n. Definitions and Terms. The questionnaires do not define certain 
key terms (e.g., effectiveness, risk, misleading). Subjects, especially 
consumers, may interpret these terms based on different standards. FDA 
might consider providing user-friendly definitions for the consumer 
subjects. The Agency should also utilize patient-friendly medical 
terms, rather than complex terminology (e.g., glaucoma, hepatic 
failure, SNRI).
    (Response) Sophisticated medical terminology will only be used in 
the HCP survey. To use the example of ``hepatic failure,'' consumers 
will instead see ``decreased liver function.'' We have verified in 
cognitive interviews that preceded this study (and in our previous 
scale development efforts) that the terminology used is generally well 
understood by our participant sample.
    o. Sliding Scale Format. FDA should consider replacing the sliding 
scale format with a ``Yes-No-I Don't Know'' scheme. The sliding-scale 
format is at times confusing in form and could potentially introduce 
error. Alternatively, the Agency should consider changing the sliding 
scale to an odd number system to permit a ``neutral'' response and/or 
use a variation of the Likert scale.
    (Response) Use of a sliding scale allows for greater precision and 
variation in response, as opposed to a ``Yes-No-Don't Know'' format. 
Research suggests that scales with five to seven points are more valid 
and reliable than those with only two to three categories (Ref. 16). 
Additionally, we tested the sliding-scale format in previous cognitive 
interviews and found that it worked well; participants had little 
difficulty understanding this format. Further, as noted in the response 
to Comment 2c, we want to avoid leading participants to choose a 
``Don't know'' response; providing this option may cue participants to 
select this response and avoid deeper thinking on the topic. Regarding 
the use of an even numbered scale rather than odd numbered scale, 
please see our response to Comment 2c.
    p. An ``FDA employee'' category should be added to Question S2 
[Consumer] of Study 1. These individuals should also be terminated from 
the study.
    (Response) Consistent with previous surveys, we added a category to 
exclude

[[Page 58418]]

employees of the Department of Health and Human Services, which 
includes employees of FDA.
    q. Question S3 [Consumer] of Study 1 should be rewritten as 
follows: ``Have you ever been diagnosed with chronic or long-lasting 
pain (more than aches and pains that go away quickly or are minor)?'' 
(emphasis added). This change aligns the question with the description 
of the study in the PRA Notice: ``Study 1 will sample consumers with 
diagnosed chronic pain that has lasted at least 3 months.''
    (Response) We did not restrict people to be diagnosed with chronic 
pain because the prevalence was too small, which would increase the 
costs of the study. Using our current screening questions, we achieve 
an 11 percent prevalence rate (Ref. 6). The objective of our sampling 
plan is to target people that would be in the audience for the ads; 
being diagnosed is not a criterion.
    r. Question S5 [Consumer] of Study 1 should be eliminated. Whether 
a subject still has chronic pain has no bearing on the study's purpose. 
Also, consider eliminating Question Q12 of Study 1. This question would 
only apply to those consumers currently being treated for chronic pain, 
not those who previously had the condition.
    (Response) Assessing whether participants currently experience 
chronic pain helps to ensure a motivated sample for which the 
fictitious medication would potentially be of interest. Originally, we 
included participants that reported suffering from chronic pain in the 
past, but we did not require that they are currently suffering from 
chronic pain (although we had an item that asked ``Do you still have 
this chronic or long-lasting pain?''). After further consideration, we 
opted to revise the screener so that participants remain eligible if 
(a) they say ``Yes'' I still have chronic pain, or (b) they say ``No'' 
(or remain silent) about still having chronic pain and they are 
currently taking a prescription drug for chronic pain. This would also 
make the inclusion criteria for Study 1 consistent with the inclusion 
criteria for Study 2, which requires that a person currently suffers 
from the medical condition of interest. Consequently, Q12 of Study 1 
will be relevant for all consumers completing the questionnaire.
    s. Consider revising Question S5 [PCP] of Study 1 to inquire: (1) 
What percentage of the PCP's patients has each condition, and (2) how 
long the PCP has treated patients with each condition. A PCP's 
familiarity and experience with the treatment of the particular 
condition provides context and serves as a reference for detecting any 
potential deception in promotional materials.
    (Response) We appreciate how these additional questions could 
provide valuable context and propose adding new items to our pretest 
survey (see below). We have found, in past work, that HCPs often have 
difficulty recalling precise information about their practice. 
Consequently, our approach is to assess this information more 
generally. However, to include some additional context, we included two 
additional items:
     Rate your current knowledge about prescription drugs for 
[weight loss/chronic pain] on a scale of 0 to 10, where 0 means knowing 
nothing and 10 means knowing everything you could possibly know about 
the topic.
     [If ``chronic pain''] Approximately what proportion of 
your current patients do you treat for chronic pain? (None or very few 
have chronic pain; a small proportion have chronic pain; about one-half 
have chronic pain; a large proportion have chronic pain; almost all 
have chronic pain).
    t. Question Q2 of Study 1 should have a third answer choice: 
``Don't remember.''
    (Response) In cognitive interviews, very few people chose this 
response option. Moreover, in previous research, because so few people 
chose this response option, we often end up collapsing this response 
option with the response indicating that the referent was not mentioned 
in the website.
    u. Questions Q5 and Q7 of Study 1 should be deleted. Whether a 
subject considers the website to be ``Bad/Good'' or ``Boring/
Interesting'' has no relevance to FDA's study goals.
    (Response) These items help to mask the overall intent of the other 
items in this series (e.g., to assess whether the website is 
misleading). Also, they provide useful information about personal 
relevance and attitude toward the website, which we can use as 
potential covariates.
    v. The commenter recommends revising Question Q17 of Study 1: ``How 
likely are you to ask your doctor about [Drug]?''
    (Response) The intent of this item is to assess information-seeking 
more broadly, which can include, but is not limited to, asking one's 
doctor about a drug. While assessing how consumers access information 
from various sources (doctor, family members, etc.) is of interest, our 
survey does not have room to ask about each source individually. Given 
that there are multiple sources of information a consumer might consult 
for more information on a drug, we decided to address information-
seeking more broadly with one question, rather than attempting to list 
all possible options.
    w. Questions Q19 and Q21 of Study 1 should be removed. These 
questions require participants to guess whether the material would 
mislead people or ``takes advantage of less experienced'' consumers/
providers. FDA should only ask participants about individual 
perception. Additionally, it is unclear what the Agency means by 
``takes advantage of less experienced'' consumers/providers.
    (Response) To avoid redundancy, we dropped Q21. We retained Q19 to 
ensure assessment of a critical construct. Because deception is a 
complicated construct to measure, we included a variety of items to 
capture the various dimensions of this construct. Based on a review of 
the literature, we recommend using a variety of relatively sensitive 
measures of ability to detect misleading advertisements to ensure we 
capture potentially meaningful variance. The inclusion of Q19 and Q21 
were based on findings from the literature review that included 
measures that tapped into third-person perception (Ref. 17)--which is 
among the most widely replicated phenomena across media contents (Ref. 
18), such as DTC prescription drug advertising (Ref. 19). By including 
an item that taps into third-person effects, we will be able to explore 
if consumers are more likely to think that others will be misled, even 
if they do not think they are susceptible to being misled by the 
website.
    x. Question Q24 of Study 1 should be one of the first questions of 
the survey. A subject will likely answer this question most accurately 
immediately after reviewing the website and before answering other 
questions that could influence this answer.
    (Response) To avoid bias, the most critical questions should appear 
as up front as possible in the surveys. Although current question 
ordering may bias responses to the attention item, this outcome is less 
consequential and we chose instead to prioritize the key dependent 
variables (putting those measures that rely on memory at the start of 
the survey). Consequently, we intend to retain the current order of 
questions in the survey.
    y. The box for Question Q30 of Study 1 prompts the subject to 
respond, even if the individual did not select anything in the website 
as false or misleading. FDA should consider using a tiered response:
    Q30a: Did you notice anything on the website that is false or 
misleading?
    1. Yes (go to question 30b).

[[Page 58419]]

    2. No (go to question 31).
    Q30b: What information was false or misleading? [open box comment]
    (Response) A programming note was missing in the original survey 
draft. The current survey programming reflects the approach suggested 
by the commenter.
    z. The commenter recommends revising Question Q32 of Study 1 to: 
``If there was a way to report misleading prescription drug websites or 
ads to the Food and Drug Administration (FDA) by sending an email or 
calling a toll-free phone number, how likely would you report 
misleading material?''
    (Response) We have adopted this recommendation in the revised 
survey.
    aa. As previously stated in footnote 21, Questions Q34, Q41, and 
Q42 of Study 1 should be deleted.
    Footnote 21 reads: For example, FDA completed a HCP study 
incorporating information asked at Q34, Q41, and Q42 of Study 1. It is 
not clear why the Agency is undertaking another study focusing on such 
questions. These questions should be eliminated.
    (Response) Please see our response to Comment 3d.
    bb. Question S1 of Study 2 should be rewritten as follows: ``Have 
you ever been diagnosed with obesity, defined as body mass index 
greater than or equal to 30?'' This change aligns the question with the 
description of the study in the PRA Notice: ``Study 2 will sample 
consumers diagnosed with obesity. . . .''
    (Response) For this study, our intent was to target people that 
would be in the audience for these ads, and being diagnosed is not a 
requirement for personal relevance. The target audience is consumers 
with a body mass index greater than or equal to 30.
    cc. The ``Debriefing'' does not accurately portray the purpose of 
the studies. The purpose of the studies is not ``to learn about how 
people feel about information provided in prescription drug websites 
aimed at consumers/providers and how people use this information to 
understand how well prescription drugs work.'' The commenter recommends 
that the ``Debriefing'' read: ``The purpose of this study is to 
investigate the ability of consumers/providers to identify false or 
misleading prescription drug promotion and how likely consumers/
providers are to report false or misleading prescription drug promotion 
to regulatory authorities.''
    (Response) We have adopted this recommendation.
    (Comment 4) regulations.gov tracking number 1k1-8v3r-jacf 
(summarized for brevity):
    a. The commenter expressed concern about the practical utility of 
the consumer-oriented arms of the research. Namely, if consumers are 
unfamiliar with the prescribing information for the product, it is 
unclear on which basis they can determine a claim to be deceptive.
    (Response) Please see our response to Comment 3f, which addresses a 
similar theme and may provide useful context. The concern addressed by 
the commenter is framed as a limitation of the study and appears to 
question the relevance of examining consumers' ability to detect 
deception in prescription drug promotion. We believe the opposite is 
correct: The merit of conducting the study is reinforced by the 
observation that it is unclear how consumers can determine a claim to 
be deceptive if they lack relevant background information or knowledge 
about an advertised drug. While prescription drug promotions are 
required to present truthful and non-misleading information, some 
prescription drug promotion nevertheless includes false or misleading 
claims, images, or presentations. DTC prescription drug promotion can 
help provide consumers with truthful information about drugs. When it 
does so, it can help consumers to make well-informed decisions when 
determining whether to explore treatment options and when making 
ultimate treatment choices, and it can provide useful and actionable 
information about a product's efficacy and risks to consumers already 
on treatment, among other outcomes. Yet, because the information in 
prescription drug promotion is not always truthful, consumers must make 
judgments about whether it is true, misleading, or false. And the same 
background knowledge that a consumer might rely on to identify a claim 
as deceptive would also be used to decide that a claim is true. As the 
commenter points out, this background information may be incomplete or 
inadequate for the task, and yet some presume that consumers (and, for 
that matter, healthcare providers) are typically able to distinguish 
between true claims and those that are false or misleading. Concerns 
like the one voiced here and the empirical literature on the topic 
suggest there is reason to doubt this presumption, thus warranting the 
proposed study.
    b. The commenter expressed concern that the varied causes of 
obesity will result in a heterogeneous population which could 
potentially confound the results of the study.
    (Response) We consider diversity within this illness population to 
be an asset. Also, random assignment will help to control extraneous 
influences because it will create groups that, on average, are 
probabilistically similar to each other. Because randomization 
eliminates most other sources of systematic variation, researchers can 
be reasonably confident that any effect that is found is the result of 
the intervention and not some preexisting differences between the 
groups (Ref. 20). Consequently, the varied causes of obesity should not 
impact the results. The primary intention of the research is to 
empirically examine consumer and HCP ability to detect and report 
deceptive prescription drug promotion, but we have to choose stimuli 
(and by extension, an illness population) in order to empirically test 
our research questions. By choosing illness conditions with diverse 
patient populations, we can better grasp how consumers and HCPs from 
all walks of life react to deceptive prescription drug promotion. Also 
see response to comment 3j.
    (Comment 5) regulations.gov tracking number 1k1-8v3v-v60p (verbatim 
with header and footer language, introductory language, and supporting 
references removed):
    We strongly support FDA's proposed project as part of the Agency's 
broader research efforts to better understand the impact of 
prescription drug promotion and direct-to-consumer advertising (DTC). 
Research regarding deceptive advertising is becoming increasingly 
important as DTC continues to grow at unprecedented rates. One analysis 
estimated DTC spending in 2015 at $5.2 billion--a growth of over 60 
percent in just 4 years. Five drugs--HUMIRA, LYRICA, ELIQUIS, CIALIS, 
and XELJANZ--accounted for one-quarter of this $5.2 billion. 
Importantly, these figures are an underestimate, as they do not account 
for spending on digital ads and social media.
    The risks and benefits of DTC have been well noted and debated. DTC 
may promote patient dialogue with healthcare providers and remove the 
stigma associated with certain diseases. However, there are also 
significant concerns that DTC may be misleading, overemphasize a drug's 
benefits as compared to risks, and lead to inappropriate prescribing 
and overutilization.
    Again, we applaud the FDA's efforts in this important area. The 
need to better understand the ability of consumers and healthcare 
professionals to detect and report misleading DTC is critical as the 
use of DTC continues to

[[Page 58420]]

grow. Thank you for the opportunity to provide these comments.
    (Response) FDA appreciates this support.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Number of
               Activity                 Number of respondents    responses per   Total annual          Average burden per response          Total hours
                                                                  respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study screener completes.......  4,286 (chronic pain)...               1           5,612  0.03 (2 minutes)........................             187
                                       714 (obesity)..........
                                       612 (HCP)
                                      -------------------------
                                       5,612 total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main study screener completes........  10,714 (chronic pain)..               1          14,031  0.03 (2 minutes)........................             468
                                       1,786 (obesity)........
                                       1,531 (HCP)
                                      -------------------------
                                       14,031 total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pilot study completes................  150 (chronic pain).....               1             600  0.33 (20 minutes).......................             200
                                       150 (obesity)..........
                                       300 (HCP)
                                      -------------------------
                                       600 total
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main study completes.................  375 (chronic pain).....               1           1,500  0.33 (20 minutes).......................             500
                                       375 (obesity)..........
                                       750 (HCP)
                                      -------------------------
                                       1,500 total
--------------------------------------------------------------------------------------------------------------------------------------------------------
    Total............................  .......................  ..............  ..............  ........................................           1,355
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

III. References
    The following references are on display in the Dockets Management 
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 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 https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. Faerber, A.E. and D.H. Kreling. ``Content Analysis of False and 
Misleading Claims in Television Advertising for Prescription and 
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Perception: Evidence from a Meta-Analysis.'' Journal of 
Communication, 58(2), 280-300, 2008.
19. DeLorme, D.E., J. Huh, and L.N. Reid. ``Perceived Effects of 
Direct-To-Consumer (DTC) Prescription Drug Advertising on Self and 
Others.'' Journal of Advertising, 35(3), 47-65, 2006.
20. Fisher, R.A. The Design of Experiments. Edinburgh, United 
Kingdom: Oliver and Boyd, 1937.

    Dated: December 6, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-26704 Filed 12-11-17; 8:45 am]
 BILLING CODE 4164-01-P