Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Perceptions of Prescription Drug Products With Medication Tracking Capabilities, 27518-27521 [2023-09268]
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Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices
and associated materials (see
ADDRESSES).
CMS 10853 Patient Provider Dispute
Resolution Requirements Related to
Surprise Billing: Part II
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
ddrumheller on DSK120RN23PROD with NOTICES1
Information Collection
1. Type of Information Collection
Request: New collection (Request for a
new OMB control number); Title of
Information Collection: Patient Provider
Dispute Resolution Requirements
Related to Surprise Billing: Part II; Use:
The Consolidated Appropriations Act,
2021 (CAA), which includes the No
Surprises Act provides Federal
protections against surprise billing and
limits out-of-network cost sharing under
many of the circumstances in which
surprise bills arise most frequently.
The Act adds a new Part E of title
XXVII of the Public Health Service Act
establishing requirements applicable to
providers, and facilities. These include
provisions at new PHS Act sections
2799B–6 which requires providers and
facilities to furnish a good faith estimate
of expected charges upon request or
upon scheduling an item or service for
an individual. Providers and facilities
are required to inquire if an individual
is enrolled in a group health plan, group
or individual health insurance coverage,
a Federal Employees Health Benefits
(FEHB) plan, or a Federal health care
program and if enrolled in a group
health plan, or group or individual
health insurance coverage, or a health
benefits plan under chapter 89 of title 5,
whether the individual is seeking to
have a claim for such item or service
submitted to such plan or coverage
(hereafter referred to as an ‘‘uninsured
(or self-pay) individual’’). In the case
that an uninsured (or self-pay)
individual requesting a good faith
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estimate for an item or service or
schedules an item or service to be
furnished, PHS Act section 2799B–
6(2)(B) and the October 2021 interim
final rules at 45 CFR 149.610 require
providers and facilities to furnish the
good faith estimate to the uninsured (or
self-pay) individual.
No Surprises Act section 112 also
adds PHS Act section 2799B–7 as added
by the interim final rules at 45 CFR
149.620 which directs the Secretary of
HHS to establish a process under which
an uninsured (or self-pay) individual
can avail themselves of a patientprovider dispute resolution (PPDR)
process if their billed charges after
receiving an item or service are
substantially in excess of the expected
charges listed in the good faith estimate
furnished by the provider or facility,
pursuant to PHS Act section 2799B–6.
This information collection request
(ICR) focuses on the patient-provider
dispute resolution process requirements
under the October 2021 interim final
rules (October 7, 2021, 86 FR 55980).
www.reginfo.gov/public/do/PRAMain.
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, PRAStaff@fda.hhs.gov.
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.
Dated: April 26, 2023.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
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 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
[FR Doc. 2023–09198 Filed 5–1–23; 8:45 am]
BILLING CODE P
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.
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.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
ADDRESSES:
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Perceptions of Prescription Drug
Products With Medication Tracking
Capabilities
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Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices
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,
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). These data
can then be transmitted to a paired
mobile device and viewed by the patient
through a smartphone app (Ref. 12).
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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:
• 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
Disclosure about
technology’s effect on
adherence
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.
No ...............................
Yes .............................
Yes .............................
No.
No.
Yes .............................
Yes .............................
Yes .............................
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/
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Experimental condition
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Content of disclosure
No data are available on the technology’s effect on adherence.
Data show the technology has no effect on
adherence.
11/20/2018-25206/prescription-drug-use-relatedsoftware-establishment-of-a-public-docket-requestfor-comments.
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Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices
TABLE 1—PROPOSED ONE-WAY, FIVE-LEVEL DESIGN (1 × 5)—Continued
Experimental condition
5. Drug + medication tracking technology +
data show a positive effect on adherence.
Claims about
existence of
medication tracking
technology
Disclosure about
technology’s effect on
adherence
Yes .............................
Yes .............................
Content of disclosure
Data show the technology has a positive effect on adherence.
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
the questionnaire programming works
as expected. For the main study, we will
then recruit 350 consumers who selfidentify as having been diagnosed with
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
(regulations.gov tracking number lar–
vv69–9wok).
FDA estimates the burden of this
collection of information as follows:
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.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
responses per
respondent
Number of
respondents
Activity
Total annual
respondents
Screener Consumers ........................
Screener Primary Care Physicians ...
Pretest Consumers ...........................
Pretest Primary Care Physicians ......
Main Study Consumers ....................
Main Study Primary Care Physicians
680
680
50
50
350
350
1
1
1
1
1
1
680
680
50
50
350
350
Total ...........................................
........................
........................
........................
1 There
Average burden per response
.08
.08
.33
.33
.33
.33
Total hours
(5 minutes) .................................
(5 minutes) .................................
(20 minutes) ...............................
(20 minutes) ...............................
(20 minutes) ...............................
(20 minutes) ...............................
54.4
54.4
16.5
16.5
115.5
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
ddrumheller on DSK120RN23PROD with NOTICES1
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://
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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.
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.
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* 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.
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Federal Register / Vol. 88, No. 84 / Tuesday, May 2, 2023 / Notices
* 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.
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: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Notice; establishment of a
public docket; request for information
and comments.
ACTION:
A Risk-Based Approach to Monitoring
of Clinical Investigations—Questions
and Answers; Guidance for Industry;
Correction
Food and Drug Administration,
HHS.
Notice of availability;
correction.
ACTION:
ddrumheller on DSK120RN23PROD with NOTICES1
Food and Drug Administration,
HHS.
[Docket No. FDA–2019–D–0362]
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of April 12, 2023. The
document announced the availability of
a final guidance entitled ‘‘A Risk-Based
Approach to Monitoring of Clinical
Investigations—Questions and Answers;
Guidance for Industry.’’ The notice of
availability for this final guidance was
published with an incorrect OMB
control number. This document corrects
that error.
FOR FURTHER INFORMATION CONTACT:
Mona Shing, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration
18:14 May 01, 2023
BILLING CODE 4164–01–P
Methodological Challenges Related to
Patient Experience Data; Request for
Information and Comments
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
[FR Doc. 2023–09264 Filed 5–1–23; 8:45 am]
[Docket No. FDA–2023–N–1506]
BILLING CODE 4164–01–P
SUMMARY:
Dated: April 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2023–09268 Filed 5–1–23; 8:45 am]
AGENCY:
Ave., Bldg. 51, Rm. 3355, Silver Spring,
MD 20993–0002, 301–796–0910.
SUPPLEMENTARY INFORMATION: In the
Federal Register of April 12, 2023 (88
FR 22038), in FR Doc. 2023–07687, the
following correction is made:
1. On page 22040, in the first column,
in the last sentence of ‘‘II. Paperwork
Reduction Act of 1995,’’ the OMB
control number 0910–0733 is corrected
to read: ‘‘. . .and the collections of
information in FDA’s guidance for
industry entitled ‘‘Oversight of Clinical
Investigations—A Risk-Based Approach
to Monitoring’’ have been approved
under OMB control number 0910–
0014.’’ The correction changes the OMB
control number from a number that was
discontinued to an active one.
The Food and Drug
Administration (FDA or Agency) is
establishing a public docket to collect
comments on methodological challenges
related to patient experience data in the
context of the benefit-risk assessment
and product labeling, and other areas of
greatest interest or concern to public
stakeholders. Public comments will
help FDA plan two public workshops
focused on methodological challenges
and identify priorities for future work.
DATES: Although you can comment at
any time, to ensure the Agency
considers your comment in our
development of the workshops, submit
either electronic or written information
and comments by July 3, 2023.
ADDRESSES: You may submit comments
and information at any time as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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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
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–
2023–N–1506 for ‘‘Methodological
Challenges Related to Patient
Experience Data.’’ Received comments
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
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]]>Agencies
[Federal Register Volume 88, Number 84 (Tuesday, May 2, 2023)]
[Notices]
[Pages 27518-27521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09268]
-----------------------------------------------------------------------
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 https://www.reginfo.gov/public/do/PRAMain. 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,
[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.
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
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, 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). 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:
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
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.
[[Page 27520]]
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 (regulations.gov 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
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.
[[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 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: 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
