[Federal Register Volume 87, Number 184 (Friday, September 23, 2022)]
[Notices]
[Pages 58099-58102]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) 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 ``Endorser Status and 
Actual Use in Direct-to-Consumer Television Ads.''

DATES: Submit either electronic or written comments on the collection 
of information by November 22, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 22, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 22, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     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.
     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-2022-N-1886 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Endorser Status and Actual Use in 
Direct-to-Consumer Television Ads.'' 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.
     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

[[Page 58100]]

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: Regarding the collection of 
information: 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].
    For copies of the questionnaire: Amie O'Donoghue, Office of 
Prescription Drug Promotion (OPDP) Research Team, 
[email protected].

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.

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 (the 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 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 DTC prescription drug 
promotion. This study complements one that is currently in progress 
(FDA-2019-N-5900, OMB control number 0910-0894, Expiration Date: 
February 29, 2024). 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 direct-to-consumer (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

[[Page 58101]]

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 
2x3 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
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                                                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.
    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       Total hours
                                                 respondents     respondent       responses                    hours)\ 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
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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
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Study 2 Pretest Questionnaire Completes......             126               1             126  .30 (18 minutes).........................              38
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                                                                   Study 1 Main Study
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Study 1 Main Study Screener Completes........           3,240               1           3,240  .03 (2 minutes)..........................            97.2
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Study 1 Main Study Questionnaire Completes...             648               1             648  .30 (18 minutes).........................             194
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                                                                   Study 2 Main Study
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Study 2 Main Study Screener Completes........           2,160               1           2,160  .03 (2 minutes)..........................            64.8
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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

[[Page 58102]]

Pharmacy, Vol. 11, Issue 6, pp. 891-900, 2015.
3. *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: September 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20617 Filed 9-22-22; 8:45 am]
BILLING CODE 4164-01-P


