Agency Information Collection Activities; Proposed Collection; Comment Request; Perceptions of Prescription Drug Products With Medication Tracking Capabilities, 58103-58106 [2022-20636]
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
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SUPPLEMENTARY INFORMATION:
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I. Background
FDA is announcing the availability of
a final guidance for industry entitled
‘‘Exemption and Exclusion from Certain
Requirements of the Drug Supply Chain
Security Act for the Distribution of
FDA-Approved Naloxone Products
During the Opioid Public Health
Emergency.’’ We are issuing this
guidance consistent with our good
guidance practices (GGP) regulation
(§ 10.115 (21 CFR 10.115)). We are
implementing this guidance without
prior public comment because we have
determined that prior public
participation is not feasible or
appropriate (§ 10.115(g)(2)). The Agency
made this determination because the
guidance requires immediate
implementation for public health
reasons. Although this guidance
document is immediately in effect, it
remains subject to comment in
accordance with FDA’s GGP regulation.
Combating the opioid overdose
epidemic is an urgent public health
priority for FDA. Naloxone is a
medication that rapidly reverses the
effects of opioid overdose and is the
standard treatment for opioid overdose.
FDA understands that naloxone is being
made available to underserved
communities through entities such as
harm reduction programs. FDA is aware
of concerns that harm reduction
programs are having difficulty acquiring
naloxone. The Agency is aware that
some stakeholders have viewed as a
contributing factor the current
availability of approved naloxone
products only as prescription drugs and
FDA has recently become aware that
some stakeholders have viewed as a
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contributing factor certain requirements
under the Drug Supply Chain Security
Act (DSCSA) for distribution of FDAapproved prescription drug products.,
e.g., being an authorized trading partner.
FDA is issuing this guidance to clarify
the scope of the public health
emergency exclusion and exemption
under the DSCSA as they apply to the
distribution of FDA-approved naloxone
products indicated for the emergency
treatment of opioid overdose to harm
reduction programs during the opioid
public health emergency.
The guidance represents the current
thinking of FDA on ‘‘Exemption and
Exclusion from Certain Requirements of
the Drug Supply Chain Security Act for
the Distribution of FDA-Approved
Naloxone Products During the Opioid
Public Health Emergency.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20552 Filed 9–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1874]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Perceptions of
Prescription Drug Products With
Medication Tracking Capabilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
SUMMARY:
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comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a proposed study
entitled ‘‘Perceptions of Prescription
Drug Products With Medication
Tracking Capabilities.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by
November 22, 2022.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
November 22, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2022–N–1874 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Perceptions of Prescription Drug
Products With Medication Tracking
Capabilities.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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
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and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Regarding the collection of
information: JonnaLynn Capezzuto,
Office of Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
For copies of the questionnaire: Amie
O’Donoghue, Office of Prescription Drug
Promotion (OPDP) Research Team, 301–
796–0754, DTCresearch@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Perceptions of Prescription Drug
Products With Medication Tracking
Capabilities
OMB Control Number 0910—NEW
Section 1701(a)(4) of the Public
Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to
conduct research relating to health
information. Section 1003(d)(2)(C) of the
Federal Food, Drug, and Cosmetic Act
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(FD&C Act) (21 U.S.C. 393(d)(2)(C))
authorizes FDA to conduct research
relating to drugs and other FDAregulated products in carrying out the
provisions of the FD&C Act.
The mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the public health by helping
to ensure that prescription drug
promotional material is truthful,
balanced, and accurately communicated
so that patients and health care
providers can make informed decisions
about treatment options. OPDP’s
research program provides scientific
evidence to help ensure that our
policies related to prescription drug
promotion will have the greatest benefit
to public health. Toward that end, we
have consistently conducted research to
evaluate the aspects of prescription drug
promotion that are most central to our
mission, focusing in particular on three
main topic areas: advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and the
characteristics of the disease and
product impact the communication and
understanding of prescription drug risks
and benefits. Focusing on target
populations allows us to evaluate how
understanding of prescription drug risks
and benefits may vary as a function of
audience. Our focus on research quality
aims at maximizing the quality of
research data through analytical
methodology development and
investigation of sampling and response
issues. This study will inform the first
topic area, advertising features.
Because we recognize that the
strength of data and the confidence in
the robust nature of the findings are
improved through the results of
multiple converging studies, we
continue to develop evidence to inform
our thinking. We evaluate the results
from our studies within the broader
context of research and findings from
other sources, and this larger body of
knowledge collectively informs our
policies as well as our research program.
Our research is documented on our
home page at https://www.fda.gov/
about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drugpromotion-opdp-research, which
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
Patient non-adherence to medication
regimens is a well-known challenge in
health care. The World Health
Organization defines adherence as the
extent to which a person’s behavior—
taking medication, following a diet,
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and/or executing lifestyle changes—
corresponds with agreed
recommendations from a health care
provider (Ref. 1). It is estimated that
only half of all patients with chronic
health conditions take their medications
as prescribed (Ref. 2), leading to as
many as 100,000 preventable deaths and
$100 billion in additional medical costs
every year (Ref. 3). Numerous solutions
have been tried to improve adherence,
including resource-intensive approaches
such as directly observed therapy,
which entails a trained observer
watching as the patient takes their
medications (Ref. 4), and technologysupported tools for patients (e.g.,
smartphone apps) (Ref. 5). As attention
to the public health issue of medication
adherence has grown, OPDP has noted
a corresponding increase in the number
of claims and presentations in
prescription drug promotion that focus,
either directly or through implication,
on a product’s potential to improve
adherence to treatment regimens. Many
of these presentations include
information about options and
capabilities available to help patients
track their medication usage.
One avenue that prescription drug
sponsors have begun exploring to track
medication use includes the
development of software that is
disseminated by or on behalf of the drug
sponsor and accompanies one or more
of the sponsor’s prescription drugs. This
software is called prescription drug userelated software.1 Studies exploring
drug products with prescription drug
use-related software have been
conducted with medications to treat an
array of chronic disorders, including
psychiatric disorders (Ref. 6),
uncontrolled type 2 diabetes (Ref. 7),
end-stage renal disease requiring
transplants (Ref. 8), and opioid use
among patients with acute fractures
(Ref. 9).
In recent years, new technologies that
capture data on medication-taking
behavior and drug administration have
been employed. The SureClick 2.0
autoinjector for the prescription
medication ENBREL, for example, has
Bluetooth built into the white cap that
covers the needle. The autoinjector
records initial removal of the cap and
can send this data via Bluetooth to a
paired smartphone using a mobile app
(Ref. 10). Technology can also now
support the use of ingestible sensors
embedded in pills that will emit a weak
signal to a receiver (patch or lanyard)
worn by the patient after the pill has
been swallowed (Ref. 11). This data can
then be transmitted to a paired mobile
device and viewed by the patient
through a smartphone app (Ref. 12).
Whether these new technologies will
have an impact on adherence is
currently unknown.
Very little is known about patient and
health care provider perceptions of
products that track medication use or
that work in tandem with software to
track medication use, with most
commentaries having been largely
theoretical (Refs. 13, 14). The focus of
the present study is to explore patient
58105
and health care provider perceptions of
a fictitious prescription drug product
that is accompanied by software that is
intended to track medication use.
We have the following specific
questions:
Research questions:
1. When prescription drug
promotional communications include
claims about a product’s ability to track
medication use, do these claims
influence perceptions about the
product’s risks and/or benefits
(including its effect on medication
adherence)?
2. If the promotional claims about the
product’s ability to track medication use
are accompanied by a disclosure that
describes what is known about the effect
of medication tracking on medication
adherence, does this have an influence
on perceptions of the product’s risks
and/or benefits (including its effect on
medication adherence)?
To complete this research, we propose
the design in table 1, which varies based
on:
• Whether the fictitious prescription
drug product includes technology that
tracks medication use;
• Whether the prescription drug
promotional communication includes a
disclosure describing what is known
about the tracking technology’s effect on
medication adherence; and
• What the disclosure communicates
about the tracking technology’s effect on
medication adherence (positive effect
shown, no effect shown, or unknown
effect).
TABLE 1—PROPOSED ONE-WAY, FIVE-LEVEL DESIGN (1 × 5)
Claims about
existence of
medication
tracking
technology
Experimental condition
1. Drug ..........................................................................
2. Drug + medication tracking technology ....................
3. Drug + medication tracking technology + no adherence data collected.
4. Drug + medication tracking technology + data show
no effect on adherence.
5. Drug + medication tracking technology + data show
a positive effect on adherence.
Disclosure
about
technology’s
effect on
adherence
No
Yes
Yes
No.
No.
Yes
Yes
Yes
Yes
Yes
Content of disclosure
No data is available on the technology’s effect on adherence.
Data show the technology has no effect on adherence.
Data show the technology has a positive effect on adherence.
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Note: Condition 5 is the only condition in which an adherence benefit has been demonstrated for the fictitious product. The evidence required
to support a medication adherence claim is not the focus of this study, and the evidence will not be described in the disclosure.
Condition 2 is a control because the drug product does include medication tracking technology, but the promotional communication does not
include a disclosure about the technology’s effect on medication adherence. Condition 1 is a true control because the drug product does not include medication tracking technology. Comparisons between conditions 1 and 2 will show us the baseline of this issue, i.e., will indicate whether
the fact that the drug product contains a tracking technology will alter perceptions of risks and benefits (including adherence).
We will conduct pretests with 50
consumers who self-identify as having
been diagnosed with diabetes and 50
primary care physicians who treat
diabetes (both obtained from a webbased research vendor) to ensure that
1 In 2018, FDA established a public docket to
solicit public comment on a proposed framework
for regulating software applications disseminated
by or on behalf of drug sponsors for use with one
or more of their prescription drug products. See
https://www.federalregister.gov/documents/2018/
11/20/2018-25206/prescription-drug-use-relatedsoftware-establishment-of-a-public-docket-requestfor-comments.
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Federal Register / Vol. 87, No. 184 / Friday, September 23, 2022 / Notices
the questionnaire programming works
as expected. For the main study, we will
then recruit 350 consumers who selfidentify as having been diagnosed with
diabetes and 350 primary care
physicians who treat diabetes. Each
participant will see one of five versions
of a consumer web page for a fictitious
prescription diabetes treatment, as
reflected in table 1. They will answer a
questionnaire designed to take no more
than 20 minutes regarding their
perception of the product’s benefits,
risks, and effect on adherence.
FDA estimates the burden of this
collection of information as follows:
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
respondents
Average burden
per response
Screener Consumers .....................................................
Screener Primary Care Physicians ...............................
Pretest Consumers ........................................................
Pretest Primary Care Physicians ...................................
Main Study Consumers .................................................
680
680
50
50
350
1
1
1
1
1
680
680
50
50
350
Main Study Primary Care Physicians ............................
Total ........................................................................
350
........................
1
........................
350
........................
1 There
.08
.08
.33
.33
.33
Total hours
(5 minutes) ....
(5 minutes) ....
(20 minutes) ..
(20 minutes) ..
(20 minutes) ..
54.4
54.4
16.5
16.5
115.5
.33 (20 minutes) ..
..............................
115.5
372.8
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
2 Burden
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References
The following references marked with
an asterisk (*) are on display at 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 also
are available electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. 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. World Health Organization, ‘‘Adherence
to Long-Term Therapies: Evidence for
Action,’’ p. 3, 2003, available at https://
apps.who.int/iris/handle/10665/42682,
accessed May 16, 2022.
2. Frias, J., N. Virdi, P. Raja, et al.,
‘‘Effectiveness of Digital Medicines to
Improve Clinical Outcomes in Patients
with Uncontrolled Hypertension and
Type 2 Diabetes: Prospective, OpenLabel, Cluster-Randomized Pilot Clinical
Trial,’’ Journal of Medical Internet
Research, vol. 19, Issue 7, Article e246,
2017, doi:10.2196/jmir.7833.
3. Kleinsinger, F., ‘‘The Unmet Challenge of
Medication Nonadherence,’’ The
Permanente Journal, vol. 22, Issue 3,
Article 18–033, 2018, doi:10.7812/TPP/
18–033.
4. Karumbi, J. and P. Garner, ‘‘Directly
Observed Therapy for Treating
Tuberculosis,’’ Cochrane Database of
Systematic Reviews, Issue 5, Article
CD003343, 2015, doi:10.1002/
14651858.CD003343.pub4.
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5. Dayer, L., S. Heldenbrand, P.O. Gubbins,
et al., ‘‘Smartphone Medication
Adherence Apps: Potential Benefits to
Patients and Providers,’’ Journal of the
American Pharmacy Association (2003),
vol. 53, Issue 2, pp. 172–181, 2013,
doi:10.1331/JAPhA.2013.12202.
*6. FDA, ‘‘FDA Approves Pill with Sensor
That Digitally Tracks If Patients Have
Ingested Their Medication,’’ FDA News
Release, November 13, 2017, available at
https://www.fda.gov/news-events/pressannouncements/fda-approves-pillsensor-digitally-tracks-if-patients-haveingested-their-medication, accessed May
16, 2022.
7. Browne, S.H., Y. Behzadi, and G.
Littlewort, ‘‘Let Visuals Tell the Story:
Medication Adherence in Patients with
Type II Diabetes Captured by a Novel
Ingestion Sensor Platform,’’ JMIR
mHealth uHealth, vol. 3, Issue 4, Article
e108, 2015, doi:10.2196/mhealth.4292.
8. Eisenberger, U., R.P. Wu¨thrich, A. Bock, et
al., ‘‘Medication Adherence Assessment:
High Accuracy of the New Ingestible
Sensor System in Kidney Transplants,’’
Transplantation, vol. 96, Issue 3, pp.
245–250, 2013, doi:10.1097/
TP.0b013e31829b7571.
9. Chai, P.R., S. Carreiro, B.J. Innes, et al.,
‘‘Oxycodone Ingestion Patterns in Acute
Fracture Pain with Digital Pills,’’
Anesthesia and Analgesia, vol. 125,
Issue 6, pp. 2105–2112, 2017,
doi:10.1213/ANE.0000000000002574.
*10. Amgen Inc., ‘‘Enbrel (etanercept):
Highlights of Prescribing Information,’’
revised April 2021, available at https://
www.pi.amgen.com/∼/media/amgen/
repositorysites/pi-amgen-com/enbrel/
enbrel_pi.pdf, accessed May 16, 2022.
*11. Reuter, E., ’’ ‘Smart Pill’ Startup EtectRx
Strikes Partnership with Pear
Therapeutics,’’ Med City News, January
14, 2021, available at https://
medcitynews.com/2021/01/smart-pillstartup-etectrx-strikes-partnership-withpear-therapeutics, accessed May 16,
2022.
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12. The Medical Futurist, ‘‘The Present and
Future of Digital Pills,’’ July 21, 2020,
available at https://medicalfuturist.com/
the-present-and-future-of-digital-pills,
accessed May 16, 2022.
13. George, C.E., ‘‘Should a Psychiatrist
Prescribe a Nanodrug to Help Parents
Monitor a Teen’s Adherence?,’’ AMA
Journal of Ethics, vol. 21, issue 4, article
e317–323, 2019, doi:10.1001/
amajethics.2019.317.
*14. Yang, M., ‘‘A Psychiatrist’s Perspective
on the Digital Pill,’’ KevinMD.com,
December 2, 2017, available at https://
www.kevinmd.com/blog/2017/12/
psychiatrists-perspective-digitalpill.html, accessed May 16, 2022.
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–20636 Filed 9–22–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1894]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Yale-Mayo Clinic
Centers of Excellence in Regulatory
Science and Innovation B12 Pediatric
Device Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58103-58106]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20636]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1874]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Perceptions of Prescription Drug Products With
Medication Tracking Capabilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Perceptions of
Prescription Drug Products With Medication Tracking Capabilities.''
DATES: Either electronic or written comments on the collection of
information must be submitted by November 22, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 22, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and
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Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2022-N-1874 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Perceptions of Prescription Drug
Products With Medication Tracking Capabilities.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT:
Regarding the collection of information: JonnaLynn Capezzuto,
Office of Operations, Food and Drug Administration, Three White Flint
North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-
3794, [email protected].
For copies of the questionnaire: Amie O'Donoghue, Office of
Prescription Drug Promotion (OPDP) Research Team, 301-796-0754,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Perceptions of Prescription Drug Products With Medication Tracking
Capabilities
OMB Control Number 0910--NEW
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes the FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (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.
The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotional material is truthful, balanced, and accurately
communicated so that patients and health care providers can make
informed decisions about treatment options. OPDP's research program
provides scientific evidence to help ensure that our policies related
to prescription drug promotion will have the greatest benefit to public
health. Toward that end, we have consistently conducted research to
evaluate the aspects of prescription drug promotion that are most
central to our mission, focusing in particular on three main topic
areas: advertising features, including content and format; target
populations; and research quality. Through the evaluation of
advertising features, we assess how elements such as graphics, format,
and the characteristics of the disease and product impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience. Our focus on research quality aims at maximizing
the quality of research data through analytical methodology development
and investigation of sampling and response issues. This study will
inform the first topic area, advertising features.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved through the results
of multiple converging studies, we continue to develop evidence to
inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our home page at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
Patient non-adherence to medication regimens is a well-known
challenge in health care. The World Health Organization defines
adherence as the extent to which a person's behavior--taking
medication, following a diet,
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and/or executing lifestyle changes--corresponds with agreed
recommendations from a health care provider (Ref. 1). It is estimated
that only half of all patients with chronic health conditions take
their medications as prescribed (Ref. 2), leading to as many as 100,000
preventable deaths and $100 billion in additional medical costs every
year (Ref. 3). Numerous solutions have been tried to improve adherence,
including resource-intensive approaches such as directly observed
therapy, which entails a trained observer watching as the patient takes
their medications (Ref. 4), and technology-supported tools for patients
(e.g., smartphone apps) (Ref. 5). As attention to the public health
issue of medication adherence has grown, OPDP has noted a corresponding
increase in the number of claims and presentations in prescription drug
promotion that focus, either directly or through implication, on a
product's potential to improve adherence to treatment regimens. Many of
these presentations include information about options and capabilities
available to help patients track their medication usage.
One avenue that prescription drug sponsors have begun exploring to
track medication use includes the development of software that is
disseminated by or on behalf of the drug sponsor and accompanies one or
more of the sponsor's prescription drugs. This software is called
prescription drug use-related software.\1\ Studies exploring drug
products with prescription drug use-related software have been
conducted with medications to treat an array of chronic disorders,
including psychiatric disorders (Ref. 6), uncontrolled type 2 diabetes
(Ref. 7), end-stage renal disease requiring transplants (Ref. 8), and
opioid use among patients with acute fractures (Ref. 9).
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\1\ In 2018, FDA established a public docket to solicit public
comment on a proposed framework for regulating software applications
disseminated by or on behalf of drug sponsors for use with one or
more of their prescription drug products. See https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments.
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In recent years, new technologies that capture data on medication-
taking behavior and drug administration have been employed. The
SureClick 2.0 autoinjector for the prescription medication ENBREL, for
example, has Bluetooth built into the white cap that covers the needle.
The autoinjector records initial removal of the cap and can send this
data via Bluetooth to a paired smartphone using a mobile app (Ref. 10).
Technology can also now support the use of ingestible sensors embedded
in pills that will emit a weak signal to a receiver (patch or lanyard)
worn by the patient after the pill has been swallowed (Ref. 11). This
data can then be transmitted to a paired mobile device and viewed by
the patient through a smartphone app (Ref. 12). Whether these new
technologies will have an impact on adherence is currently unknown.
Very little is known about patient and health care provider
perceptions of products that track medication use or that work in
tandem with software to track medication use, with most commentaries
having been largely theoretical (Refs. 13, 14). The focus of the
present study is to explore patient and health care provider
perceptions of a fictitious prescription drug product that is
accompanied by software that is intended to track medication use.
We have the following specific questions:
Research questions:
1. When prescription drug promotional communications include claims
about a product's ability to track medication use, do these claims
influence perceptions about the product's risks and/or benefits
(including its effect on medication adherence)?
2. If the promotional claims about the product's ability to track
medication use are accompanied by a disclosure that describes what is
known about the effect of medication tracking on medication adherence,
does this have an influence on perceptions of the product's risks and/
or benefits (including its effect on medication adherence)?
To complete this research, we propose the design in table 1, which
varies based on:
Whether the fictitious prescription drug product includes
technology that tracks medication use;
Whether the prescription drug promotional communication
includes a disclosure describing what is known about the tracking
technology's effect on medication adherence; and
What the disclosure communicates about the tracking
technology's effect on medication adherence (positive effect shown, no
effect shown, or unknown effect).
Table 1--Proposed One-Way, Five-Level Design (1 x 5)
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Claims about Disclosure
existence of about
Experimental condition medication technology's Content of disclosure
tracking effect on
technology adherence
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1. Drug....................................... No No. ................................
2. Drug + medication tracking technology...... Yes No. ................................
3. Drug + medication tracking technology + no Yes Yes No data is available on the
adherence data collected. technology's effect on
adherence.
4. Drug + medication tracking technology + Yes Yes Data show the technology has no
data show no effect on adherence. effect on adherence.
5. Drug + medication tracking technology + Yes Yes Data show the technology has a
data show a positive effect on adherence. positive effect on adherence.
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Note: Condition 5 is the only condition in which an adherence benefit has been demonstrated for the fictitious
product. The evidence required to support a medication adherence claim is not the focus of this study, and the
evidence will not be described in the disclosure.
Condition 2 is a control because the drug product does include medication tracking technology, but the
promotional communication does not include a disclosure about the technology's effect on medication adherence.
Condition 1 is a true control because the drug product does not include medication tracking technology.
Comparisons between conditions 1 and 2 will show us the baseline of this issue, i.e., will indicate whether
the fact that the drug product contains a tracking technology will alter perceptions of risks and benefits
(including adherence).
We will conduct pretests with 50 consumers who self-identify as
having been diagnosed with diabetes and 50 primary care physicians who
treat diabetes (both obtained from a web-based research vendor) to
ensure that
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the questionnaire programming works as expected. For the main study, we
will then recruit 350 consumers who self-identify as having been
diagnosed with diabetes and 350 primary care physicians who treat
diabetes. Each participant will see one of five versions of a consumer
web page for a fictitious prescription diabetes treatment, as reflected
in table 1. They will answer a questionnaire designed to take no more
than 20 minutes regarding their perception of the product's benefits,
risks, and effect on adherence.
FDA estimates the burden of this collection of information as
follows:
Table 2--Estimated Annual Reporting Burden 1 2
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent respondents
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Screener Consumers............................ 680 1 680 .08 (5 minutes)......................... 54.4
Screener Primary Care Physicians.............. 680 1 680 .08 (5 minutes)......................... 54.4
Pretest Consumers............................. 50 1 50 .33 (20 minutes)........................ 16.5
Pretest Primary Care Physicians............... 50 1 50 .33 (20 minutes)........................ 16.5
Main Study Consumers.......................... 350 1 350 .33 (20 minutes)........................ 115.5
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Main Study Primary Care Physicians............ 350 1 350 .33 (20 minutes)........................ 115.5
Total..................................... .............. .............. .............. ........................................ 372.8
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
References
The following references marked with an asterisk (*) are on display
at 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 also are available electronically at
https://www.regulations.gov. References without asterisks are not on
public display at https://www.regulations.gov because they have
copyright restriction. Some may be available at the website address, if
listed. References without asterisks are available for viewing only at
the Dockets Management Staff. 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. World Health Organization, ``Adherence to Long-Term Therapies:
Evidence for Action,'' p. 3, 2003, available at https://apps.who.int/iris/handle/10665/42682, accessed May 16, 2022.
2. Frias, J., N. Virdi, P. Raja, et al., ``Effectiveness of Digital
Medicines to Improve Clinical Outcomes in Patients with Uncontrolled
Hypertension and Type 2 Diabetes: Prospective, Open-Label, Cluster-
Randomized Pilot Clinical Trial,'' Journal of Medical Internet
Research, vol. 19, Issue 7, Article e246, 2017, doi:10.2196/
jmir.7833.
3. Kleinsinger, F., ``The Unmet Challenge of Medication
Nonadherence,'' The Permanente Journal, vol. 22, Issue 3, Article
18-033, 2018, doi:10.7812/TPP/18-033.
4. Karumbi, J. and P. Garner, ``Directly Observed Therapy for
Treating Tuberculosis,'' Cochrane Database of Systematic Reviews,
Issue 5, Article CD003343, 2015, doi:10.1002/14651858.CD003343.pub4.
5. Dayer, L., S. Heldenbrand, P.O. Gubbins, et al., ``Smartphone
Medication Adherence Apps: Potential Benefits to Patients and
Providers,'' Journal of the American Pharmacy Association (2003),
vol. 53, Issue 2, pp. 172-181, 2013, doi:10.1331/JAPhA.2013.12202.
*6. FDA, ``FDA Approves Pill with Sensor That Digitally Tracks If
Patients Have Ingested Their Medication,'' FDA News Release,
November 13, 2017, available at https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication, accessed May 16, 2022.
7. Browne, S.H., Y. Behzadi, and G. Littlewort, ``Let Visuals Tell
the Story: Medication Adherence in Patients with Type II Diabetes
Captured by a Novel Ingestion Sensor Platform,'' JMIR mHealth
uHealth, vol. 3, Issue 4, Article e108, 2015, doi:10.2196/
mhealth.4292.
8. Eisenberger, U., R.P. W[uuml]thrich, A. Bock, et al.,
``Medication Adherence Assessment: High Accuracy of the New
Ingestible Sensor System in Kidney Transplants,'' Transplantation,
vol. 96, Issue 3, pp. 245-250, 2013, doi:10.1097/
TP.0b013e31829b7571.
9. Chai, P.R., S. Carreiro, B.J. Innes, et al., ``Oxycodone
Ingestion Patterns in Acute Fracture Pain with Digital Pills,''
Anesthesia and Analgesia, vol. 125, Issue 6, pp. 2105-2112, 2017,
doi:10.1213/ANE.0000000000002574.
*10. Amgen Inc., ``Enbrel (etanercept): Highlights of Prescribing
Information,'' revised April 2021, available at https://
www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/enbrel/
enbrel_pi.pdf, accessed May 16, 2022.
*11. Reuter, E., '' `Smart Pill' Startup EtectRx Strikes Partnership
with Pear Therapeutics,'' Med City News, January 14, 2021, available
at https://medcitynews.com/2021/01/smart-pill-startup-etectrx-strikes-partnership-with-pear-therapeutics, accessed May 16, 2022.
12. The Medical Futurist, ``The Present and Future of Digital
Pills,'' July 21, 2020, available at https://medicalfuturist.com/the-present-and-future-of-digital-pills, accessed May 16, 2022.
13. George, C.E., ``Should a Psychiatrist Prescribe a Nanodrug to
Help Parents Monitor a Teen's Adherence?,'' AMA Journal of Ethics,
vol. 21, issue 4, article e317-323, 2019, doi:10.1001/
amajethics.2019.317.
*14. Yang, M., ``A Psychiatrist's Perspective on the Digital Pill,''
KevinMD.com, December 2, 2017, available at https://www.kevinmd.com/blog/2017/12/psychiatrists-perspective-digital-pill.html, accessed
May 16, 2022.
Dated: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20636 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P
