[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70669-70672]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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: 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.
    <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 https://www.regulations.gov 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 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: 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 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 
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.
    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
                                                                             ---------------------------------------------------------------------------
                                                                                     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 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

[[Page 70672]]

 
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
                                               ---------------------------------------------------------------------------------------------------------
        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 https://www.regulations.gov 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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