[Federal Register Volume 88, Number 82 (Friday, April 28, 2023)]
[Notices]
[Pages 26316-26318]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-08965]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1886]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Endorser Status and 
Actual Use in Direct-to-Consumer Television Ads

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 May 30, 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 ``Endorser Status and Actual Use in Direct-
to-Consumer Television Ads.'' Also include the FDA docket number found 
in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: PRA Staff, Office of Operations, Food 
and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA

[[Page 26317]]

has submitted the following proposed collection of information to OMB 
for review and clearance.

Endorser Status and Actual Use in Direct-to-Consumer Television Ads

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 promotional material is truthful, balanced, and accurately 
communicated. 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, and 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. The website includes 
links to the latest Federal Register notices and peer-reviewed 
publications produced by our office.
    The objective of the present research is to conduct experimental 
studies to examine issues related to endorsers in direct-to-consumer 
(DTC) prescription drug promotion. This study complements one that has 
recently been completed (FDA-2019-N-5900, OMB control number 0910-0894, 
Expiration Date: March 31, 2023). As that study examined a number of 
different endorser types in print or internet settings and focused on 
examining how various disclosures of the payment status of the endorser 
influenced audience reactions, this proposed research extends the prior 
research by examining actual-use disclosures and a different medium, 
television ads. Prior research has shown that endorsements by expert 
physicians and pharmacists were the most likely to lead to purchase 
intentions, followed by endorsements by consumers, and lastly, by 
celebrities (Refs. 1 and 2).
    For healthcare providers (HCPs) endorsing a prescription drug 
product, guiding industry principles advise that advertisements should 
contain a disclosure that the HCP has been compensated for the 
endorsement (Ref. 3). Industry guiding principles further recommend 
that an advertisement disclose when an actor is being used as an HCP to 
promote DTC prescription drugs.
    Pharmaceutical firms also often use everyday people, either actual 
patients or actors portraying patients, in DTC promotion, relying on 
qualities of identification with the individual endorsing the product 
and perceived credibility (Ref. 4). While industry guidelines recommend 
that companies choosing to feature actors in the roles of HCPs in a DTC 
television or print ad acknowledge in the ad that actors are being 
used, the guidelines do not mention disclosures that the ``patient'' in 
an ad is being portrayed by an actor (Ref. 3). Some advertisers 
endeavor to gain credibility among viewers by using actual patients to 
endorse the product, with a disclosure that states they are actual 
users of the product (``actual-use disclosure'') (Ref. 5).
    The present research will specifically examine the influence of two 
independent variables--endorser type (patient, physician) and an 
actual-use disclosure (utilizer, actor, none)--in television 
advertisements. Dependent variables will include perceptions of the 
risks and benefits of the promoted prescription drug, attitudes toward 
and perceptions of the endorser, attention paid to the ad, and 
behavioral intentions. Because age and education level may affect 
perceptions of the ad, we plan to explore whether age and education 
level influence these effects.
    This research will involve two studies. Studies 1 and 2 will use a 
2 x 3 factorial design run concurrently and independently with a sample 
of consumers who have been diagnosed with diabetes (Study 1) or 
rheumatoid arthritis (Study 2), each watching a DTC television ad for a 
fictitious drug indicated to treat the corresponding medical 
conditions. The ad will be manipulated to assess the impact of two 
categories of commonly used industry spokespeople: a patient and a 
physician. We will test three actual-use disclosure conditions: (1) an 
actual-use disclosure that indicates that the endorser either uses or 
prescribes the prescription drug in real life (i.e., utilizer), (2) an 
actual-use disclosure that specifies the endorser is an actor, and (3) 
a control with no actual-use disclosure. The design for Studies 1 and 2 
is presented in table 1.

            Table 1--Study 1 and Study 2 Experimental Design
------------------------------------------------------------------------
                                               Endorser type
      Actual-use disclosure       --------------------------------------
                                         Patient           Physician
------------------------------------------------------------------------
Utilizer.........................
Actor............................
None.............................
------------------------------------------------------------------------

    In both studies, participants will be randomly assigned to one of 
six experimental conditions (see table 1), view their assigned 
stimulus, complete a survey, and provide feedback on one of the other 
ad versions. We will conduct pretests with 126 consumers who self-
identify as having been diagnosed with diabetes and 126 consumers who 
self-identify as having been diagnosed with rheumatoid arthritis, 
recruited from a web-based research vendor. For the main study, we will 
then recruit 648 consumers who self-identify as having been diagnosed 
with diabetes and 648 consumers who self-identify as having been 
diagnosed with rheumatoid arthritis. Each participant will see one of 
six versions of a television ad for a fictitious prescription diabetes 
or rheumatoid arthritis treatment, as reflected in table 1. They will 
answer a questionnaire designed to take no more than 20 minutes.
    In the Federal Register of September 23, 2022 (87 FR 58099), FDA 
published

[[Page 26318]]

a 60-day notice requesting public comment on the proposed collection of 
information. FDA received no comments.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                  Number of
                   Activity                       Number of     responses per   Total annual    Average burden  per response  (in hours)    Total hours
                                                 respondents     respondent       responses                       \2\
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                                                                     Study 1 Pretest
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Study 1 Pretest Screener Completes...........             630               1             630  .03 (2 minutes)..........................            18.9
Study 1 Pretest Questionnaire Completes......             126               1             126  .30 (18 minutes).........................              38
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                                                                     Study 2 Pretest
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Study 2 Pretest Screener Completes...........             420               1             420  .03 (2 minutes)..........................            12.6
Study 2 Pretest Questionnaire Completes......             126               1             126  .30 (18 minutes).........................              38
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Study 1 Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 1 Main Study Screener Completes........           3,240               1           3,240  .03 (2 minutes)..........................            97.2
Study 1 Main Study Questionnaire Completes...             648               1             648  .30 (18 minutes).........................             194
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                   Study 2 Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Study 2 Main Study Screener Completes........           2,160               1           2,160  .03 (2 minutes)..........................            64.8
Study 2 Main Study Questionnaire Completes...             648               1             648  .30 (18 minutes).........................             194
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................          657.50
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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 the format ``[number of minutes per response]/60.''

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. LaTour, C. and M. Smith, ``A Study of Expert Endorsement of OTC 
Pharmaceutical Products,'' Journal of Pharmaceutical Marketing & 
Management, Vol. 1, Issue 2, pp. 117-128, 1986.
2. Bhutada, N.S. and B.L. Rollins, ``Disease-Specific Direct-to-
Consumer Advertising of Pharmaceuticals: An Examination of Endorser 
Type and Gender Effects on Consumers' Attitudes and Behaviors,'' 
Research in Social and Administrative Pharmacy, Vol. 11, Issue 6, 
pp. 891-900, 2015.
3. *Pharmaceutical Research and Manufacturers of America (PhRMA), 
``PhRMA Guiding Principles: Direct to Consumer Advertisements About 
Prescription Medicines,'' Pharmaceutical Research and Manufacturers 
of America, Washington, DC, https://www.phrma.org, revised October 
2018, available at https://phrma.org/-/media/Project/PhRMA/PhRMA-Org/PhRMA-Org/PDF/P-R/PhRMA_Guiding_Principles_2018.pdf (accessed 
May 18, 2022).
4. *Schouten, A.P., L. Janssen, and M. Verspaget, ``Celebrity vs. 
Influencer Endorsements in Advertising: The Role of Identification, 
Credibility, and Product-Endorser Fit,'' International Journal of 
Advertising, Vol. 39, Issue 2, pp. 258-281, 2020, https://doi.org/10.1080/02650487.2019.1634898.
5. *Bulik, B.S., ``Merck Adds Real Patient to `TRU' Keytruda TV 
Ad,'' Fierce Pharma, September 27, 2017, available at https://www.fiercepharma.com/marketing/new-merck-tv-ad-for-keytruda-continues-tru-theme-but-now-features-real-patient (accessed May 18, 
2022).

    Dated: April 24, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-08965 Filed 4-27-23; 8:45 am]
BILLING CODE 4164-01-P


