Notice2023-09268
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Perceptions of Prescription Drug Products With Medication Tracking Capabilities
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Published
May 2, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 84 (Tuesday, May 2, 2023)</title>
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[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Pages 27518-27521]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-09268]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1874]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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.
DATES: Submit written comments (including recommendations) on the
collection of information by June 1, 2023.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The title of this
information collection is ``Perceptions of Prescription Drug Products
with Medication Tracking Capabilities.'' Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: 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,
<a href="/cdn-cgi/l/email-protection#08585a495b7c696e6e486e6c692660607b266f677e"><span class="__cf_email__" data-cfemail="adfdffecfed9cccbcbedcbc9cc83c5c5de83cac2db">[email protected]</span></a>.
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.
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
[[Page 27519]]
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
<a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research</a>, 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, 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 <a href="https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments">https://www.federalregister.gov/documents/2018/11/20/2018-25206/prescription-drug-use-related-software-establishment-of-a-public-docket-request-for-comments</a>.
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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). These
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 and 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:
<bullet> Whether the fictitious prescription drug product includes
technology that tracks medication use;
<bullet> Whether the prescription drug promotional communication
includes a disclosure describing what is known about the tracking
technology's effect on medication adherence; and
<bullet> 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
existence of Disclosure about
Experimental condition medication tracking technology's effect on Content of disclosure
technology adherence
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1. Drug............................ No.................... No....................
2. Drug + medication tracking Yes................... No....................
technology.
3. Drug + medication tracking Yes................... Yes................... No data are available on
technology + no adherence data the technology's effect on
collected. adherence.
4. Drug + medication tracking Yes................... Yes................... Data show the technology
technology + data show no effect has no effect on
on adherence. adherence.
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5. Drug + medication tracking Yes................... Yes................... Data show the technology
technology + data show a positive has a positive effect on
effect on adherence. 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 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.
In the Federal Register of September 23, 2022 (87 FR 58103), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one submission that was not
PRA-related (<a href="http://regulations.gov">regulations.gov</a> tracking number lar-vv69-9wok).
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 Total hours
respondents respondent respondents per response
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Screener Consumers............ 680 1 680 .08 (5 minutes). 54.4
Screener Primary Care 680 1 680 .08 (5 minutes). 54.4
Physicians.
Pretest Consumers............. 50 1 50 .33 (20 minutes) 16.5
Pretest Primary Care 50 1 50 .33 (20 minutes) 16.5
Physicians.
Main Study Consumers.......... 350 1 350 .33 (20 minutes) 115.5
Main Study Primary Care 350 1 350 .33 (20 minutes) 115.5
Physicians.
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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
<a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on
public display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://apps.who.int/iris/handle/10665/42682">https://apps.who.int/iris/handle/10665/42682</a>, 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 <a href="https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication">https://www.fda.gov/news-events/press-announcements/fda-approves-pill-sensor-digitally-tracks-if-patients-have-ingested-their-medication</a>, 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.
[[Page 27521]]
* 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 <a href="https://medcitynews.com/2021/01/smart-pill-startup-etectrx-strikes-partnership-with-pear-therapeutics">https://medcitynews.com/2021/01/smart-pill-startup-etectrx-strikes-partnership-with-pear-therapeutics</a>, accessed May 16, 2022.
12. The Medical Futurist, ``The Present and Future of Digital
Pills,'' July 21, 2020, available at <a href="https://medicalfuturist.com/the-present-and-future-of-digital-pills">https://medicalfuturist.com/the-present-and-future-of-digital-pills</a>, 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,'' <a href="http://KevinMD.com">KevinMD.com</a>, December 2, 2017, available at <a href="https://www.kevinmd.com/blog/2017/12/psychiatrists-perspective-digital-pill.html">https://www.kevinmd.com/blog/2017/12/psychiatrists-perspective-digital-pill.html</a>, accessed May 16, 2022.
Dated: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09268 Filed 5-1-23; 8:45 am]
BILLING CODE 4164-01-P
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