Agency Information Collection Activities; Proposed Collection; Comment Request; Adherence Potential and Patient Preference in Prescription Drug Promotion

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Published

October 12, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA, Agency, or we) 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 "Adherence Potential and Patient Preference in Prescription Drug Promotion."

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<title>Federal Register, Volume 88 Issue 196 (Thursday, October 12, 2023)</title>
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70669-70672]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22586]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-3768]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Adherence Potential and Patient Preference in
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 ``Adherence
Potential and Patient Preference in Prescription Drug Promotion.''

DATES: Either electronic or written comments on the collection of
information must be submitted by December 11, 2023.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 11, 2023. 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as

[[Page 70670]]

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-3768 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Adherence Potential and Patient
Preference in Prescription Drug Promotion.'' 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: 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#6c3c3e2d1f180d0a0a2c0a080d4204041f420b031a"><span class="__cf_email__" data-cfemail="5b0b091a282f3a3d3d1b3d3f3a75333328753c342d">[email&#160;protected]</span></a>.

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.

Adherence Potential and Patient Preference in Prescription Drug
Promotion

OMB Control Number 0910--NEW

Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (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 promotion is truthful, balanced, and accurately communicated so
that patients and healthcare 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
<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.
This study builds on OPDP's portfolio of research on market claims
and disclosures to explore the influence of statements around patient
adherence and preference in prescription drug promotion. Previous FDA-
funded research has shown that market claims that advertise drug
characteristics unrelated to medicinal properties, such as ``#1
Prescribed,'' influence consumer and provider perceptions about a
drug's efficacy (Ref. 1). In the same study, results of a tradeoff
analysis suggested that patients prefer a drug over a

[[Page 70671]]

competitor when this type of claim is present, and a drug without this
claim required at least 1.23 percent greater efficacy to be chosen over
a drug with this claim (Ref. 2). Treatment preferences may also be
influenced by other drug characteristics, including its impact on
quality of life, complexity of dosage regimens, administration mode,
and cost to family and self (Refs. 3-5).
It is not known how claims that appeal to the possibility for
greater adherence or to social norms around what other patients or
healthcare providers prefer influence perceptions of a drug. A related
question is whether including a disclosure stating the uncertainty
around such claims (e.g., there is no conclusive research on whether
DRUG A results in better adherence) can mitigate any misleading
perceptions or influence preferences. Some evidence suggests that
disclosures in prescription drug promotion are typically noticed and
may help consumers and healthcare providers understand information
(Refs. 2 and 6), but this topic has not been investigated in the
context of adherence claims.
The present research is designed to complement previous research by
experimentally examining the role of adherence and patient preference
claims in prescription drug promotion. We have the following specific
questions:
Research questions:
1. Does the presence or absence of an implied-adherence claim
affect consumers' behavioral intentions or risk, benefit, and adherence
perceptions?
2. Does the presence or absence of an adherence-related patient
preference claim affect consumers' behavioral intentions or risk,
benefit, and adherence perceptions?
3. Does the presence of both types of claims (adherence and
preference) have a cumulative impact on consumers' behavioral
intentions or risk, benefit, and adherence perceptions?
4. Does a disclosure of information to the effect that there is no
conclusive research on whether the drug results in better adherence
mitigate consumers' behavioral intentions or risk, benefit, and
adherence perceptions?
To complete this research, we will show participants a website for
a fictitious prescription drug product for type 2 diabetes. We propose
the design in table 1, which varies based on whether the fictitious
prescription drug promotional communication includes a claim about:
<bullet> implied adherence;
<bullet> patient preference; and
<bullet> a disclosure that there is no conclusive research on
adherence.

Table 1--Design 2 (Implied Adherence Claim) x 2 (Patient Preference Claim) x 2 (Disclosure)
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With disclosure \1\ Without disclosure
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Patient preference claim Patient preference claim
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Yes No Yes No
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Implied Adherence Claim........................ Yes.
No.
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\1\ E.g., ``There is no conclusive research to suggest better adherence to Drug X compared with Drug Y.''

Recruitment will occur by email through an internet panel, and
participant eligibility will be determined with a screener at the
beginning of the online survey. For the pretest, we expect to screen
253 consumers and 294 primary care physicians (PCPs) to reach our
desired number of completed surveys. We will conduct complete pretest
surveys with 160 consumers who self-identify as having been diagnosed
with diabetes and 160 PCPs 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 expect to screen 566
consumers and 660 PCPs to reach our desired number of completed
surveys. Thus, for the main study final sample, we will recruit 360
adult voluntary participants aged 18 years or older who self-identify
as having been diagnosed with diabetes and 360 voluntary participants
who are employed as PCPs who treat diabetes. We will exclude
individuals who work in healthcare settings, employees of the
Department of Health and Human Services, and individuals who work in
the marketing, advertising, or pharmaceutical industries.
The total annual estimated burden imposed by this collection of
information is 520 hours (table 2). These estimates account for over-
recruitment of 10 percent to account for survey incompletes. As with
most online and mail surveys, it is always possible that some
participants are in the process of completing the survey when the
target number is reached and that those surveys will be completed and
received before the survey is closed out. To account for this, we have
estimated approximately 10 percent overage.
Each participant will see one of eight 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 benefit and risk perceptions, adherence
perceptions, behavioral intentions, adherence claim retention, and
patient preference claim retention. The survey is available upon
request at <a href="/cdn-cgi/l/email-protection#b3f7e7f0c1d6c0d6d2c1d0dbf3d5d7d29ddbdbc09dd4dcc5"><span class="__cf_email__" data-cfemail="094d5d4a7b6c7a6c687b6a61496f6d682761617a276e667f">[email&#160;protected]</span></a>.

Table 2--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
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Pretest:
Consumers: pretest screener completes 253 1 253 0.08 (5 min.)........................... 20
(assumes 70% eligible).
Consumers: number of completes, pretest... 176 1 176 0.33 (20 min.).......................... 58
PCPs: pretest screener completes (assumes 294 1 294 0.08 (5 min.)........................... 24
60% eligible).
PCPs: number of completes, pretest........ 176 1 176 0.33 (20 min.).......................... 58

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Main Study:
Consumers: number of main study screener 566 1 566 0.08 (5 min.)........................... 45
completes (assumes 70% eligible).
Consumers: number of completes, main study 396 1 396 0.33 (20 min.).......................... 131
PCPs: number of main study screener 660 1 660 0.08 (5 min.)........................... 53
completes (assumes 60% eligible).
PCPs: number of completes, main study..... 396 1 396 0.33 (20 min.).......................... 131
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Total (rounded)....................... .............. .............. .............. ........................................ 520
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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 are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a> as these
references are copyright protected. Some may be available at the
website address, if listed. 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. Aikin, K.J., K.R. Betts, A. Keisler, and K.S. Ziemer, ``Market
Claims and Efficacy Information in Direct-to-Consumer Prescription
Drug Print Advertisements,'' Psychology & Marketing, 36(8), 747-757,
2019a.
2. Aikin, K.J., K.R. Betts, K.S. Ziemer, and A. Keisler, ``Consumer
Tradeoff of Advertising Claim Versus Efficacy Information in Direct-
to-Consumer Prescription Drug Ads,'' Research in Social and
Administrative Pharmacy, 15(12), 1484-1488, 2019b.
3. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, D. Prefasi, et al.
``Conjoint Analysis To Understand Preferences of Patients With
Multiple Sclerosis for Disease-Modifying Therapy Attributes in
Spain: A Cross-Sectional Observational Study,'' BMJ Open, 7(3),
e014433, 2017.
4. Fraenkel, L., L. Suter, C.E. Cunningham, and G. Hawker,
``Understanding Preferences for Disease-Modifying Drugs in
Osteoarthritis,'' Arthritis Care Research, 66(8), 1186-1192, 2014.
5. Wouters, H., G.A. Maatman, L. Van Dijk, M.L. Bouvy, et al.
``Trade-Off Preferences Regarding Adjuvant Endocrine Therapy Among
Women With Estrogen Receptor-Positive Breast Cancer,'' Annals of
Oncology, 24(9), 2324-2329, 2013.
6. Betts, K.R., V. Boudewyns, K.J. Aikin, C. Squire, et al.
``Serious and Actionable Risks, Plus Disclosure: Investigating an
Alternative Approach for Presenting Risk Information in Prescription
Drug Television Advertisements,'' Research in Social and
Administrative Pharmacy, 14(10), 951-963, 2018.

Dated: October 6, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-22586 Filed 10-11-23; 8:45 am]
BILLING CODE 4164-01-P

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