[Federal Register Volume 85, Number 18 (Tuesday, January 28, 2020)]
[Notices]
[Pages 4994-4997]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5900]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Endorser Status and Explicitness of Payment in Direct-
to-Consumer Promotion

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 
Explicitness of Payment in Direct-to-Consumer Promotion.''

DATES: Submit either electronic or written comments on the collection 
of information by March 30, 2020.

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 March 30, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 30, 2020. 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-2019-N-5900 for ``Endorser Status and Explicitness of Payment in 
Direct-to-Consumer 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.
     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

[[Page 4995]]

``Search'' box and follow the prompts and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, 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].
    For copies of the questionnaire contact: 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 Explicitness of Payment in Direct-to-Consumer 
Promotion; OMB Control Number 0910-NEW

I. Background

    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 Office of Prescription Drug Promotion's (OPDP) mission 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 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 disease and product characteristics 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.
    Because we recognize the strength of data and the confidence in the 
robust nature of the findings is 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 homepage, which 
can be found at: https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm090276.htm. The website 
includes links to the latest Federal Register notices and peer-reviewed 
publications produced by our office. The website maintains information 
on studies we have conducted, dating back to a direct-to-consumer (DTC) 
survey conducted in 1999.
    Advertisers have used celebrity endorsers for years, and DTC 
pharmaceutical promotion is no different. As researchers studied the 
influence of celebrity endorsers, they theorized that a correspondence 
bias occurs in which people believe that the endorser truly believes 
what they are saying. LaTour and Smith (Ref. 1) examined whether a 
pharmacist, physician, celebrity, or consumer would be most persuasive 
in advertisements for four different types of OTC products. They found 
that physicians and pharmacists were the most likely to lead to 
purchase intentions, followed by consumers, and lastly, by celebrities. 
There were no differences among types of OTC product.
    Bhutada and Rollins (Ref. 2) recently completed a study examining 
the role of endorser type (i.e., celebrity vs. expert vs. non-
celebrity), and endorser and consumer gender in product DTC ads. They 
found, like LaTour and Smith (Ref. 1), that expert endorsers were 
thought of as higher in credibility and generally resulted in the same 
amount of attention as celebrities. The authors did not find that these 
endorsers resulted in greater intentions to pursue the drug product.
    We propose to extend previous research by examining four types of 
endorsers in two separate studies (celebrity, physician, patient, 
influencer \1\) and examining whether the presence of a disclosure of 
their payment status influences participant reactions. We propose to 
also test two different types of disclosure language--one direct and 
more consumer-friendly, and one less direct.
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    \1\ ``Influencer'' is a ``regular'' person who has gained a 
following on a blog, a Twitter feed, or other social media medium.
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    To complete this research, we propose the following concurrent 
studies.\2\
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    \2\ For case allocation, the literature suggests that some 
proportion of consumers may not recall seeing the disclosure 
statement in the advertisement (see, for example, Boerman et al., 
Ref. 3). Rather than allotting equal numbers of cases to each 
condition, we will assign more cases to the disclosure present 
condition to increase power in these cells.
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Study A

[[Page 4996]]



                                        Table 1a--Study 1 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
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                                                                   Endorser
             Payment disclosure              ---------------------------------------------------      Total
                                                 Celebrity        Physician         Patient
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Present.....................................              50               50               50              150
Absent......................................              33               33               33               99
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    Total...................................              83               83               83              249
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                                      Table 1b--Study 1 Design--Main Study
                                [0.90 power, 0.05 alpha, small effect size f=.2]
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                                                                   Endorser
             Payment disclosure              ---------------------------------------------------      Total
                                                 Celebrity        Physician         Patient
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Present.....................................              81               81               81              243
Absent......................................              54               54               54              162
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    Total...................................             135              135              135              405
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    Study A will manipulate endorser type (three levels: Celebrity, 
physician, patient) and payment disclosure (two levels: Present, 
absent) within a print DTC ad for a fictitious acne product. For this 
study, we will recruit 654 general population individuals (249 pretest; 
405 main study) from a national nonprobability internet panel called 
Dynata, formerly ResearchNow. All participants must report familiarity 
with the celebrity to be included in our study. The celebrity will be 
one who has publicly spoken out about acne. We are not divulging the 
identity of the celebrity in this public forum to maintain the 
integrity of our research process. Stock photos will be used to depict 
a physician and a patient in the other experimental conditions. 
Participants will be randomly assigned to see one of the endorsers and 
to see the ad either with or without a payment disclosure. The payment 
disclosure in Study 1 will be determined in cognitive testing, but will 
be similar to: ``[Endorser] has been paid to appear in this ad for Drug 
X.''
Study B

                                        Table 2a--Study 2 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
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                                                                           Endorser
                      Payment Disclosure                      ----------------------------------      Total
                                                                  Influencer        Patient
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Present-Direct...............................................              50               50              100
Present-Indirect.............................................              50               50              100
Absent.......................................................              33               33               66
                                                              --------------------------------------------------
    Total....................................................             133              133              266
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                                      Table 2b--Study 2 Design--Main Study
                                [0.90 power, 0.05 alpha, small effect size f=.2]
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                                                                           Endorser
                      Payment Disclosure                      ----------------------------------      Total
                                                                  Influencer        Patient
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Present-Direct...............................................              81               81              162
Present-Indirect.............................................              81               81              162
Absent.......................................................              54               54              108
                                                              --------------------------------------------------
    Total....................................................             216              216              432
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    In Study B we will also manipulate endorser type, examining a 
patient and an internet influencer, one who provides online content to 
a number of followers. We will also manipulate the explicitness of the 
payment disclosure in addition to its presence, resulting in a two 
(endorser: Influencer, patient) by three (payment disclosure: Present-
direct, present-indirect, absent) between-subjects design. The 
disclosure will be direct (e.g., ``Paid ad . . .''), indirect (e.g., 
#sp for ``sponsored''), or absent. The setting for this study will be 
an Instagram post for a fictitious endometriosis product. This study 
partially replicates Study A and extends it by further tweaking the 
explicitness of payment as another manipulated variable and using a 
different set of

[[Page 4997]]

endorser types and in a different promotional setting.
    For Study B, we will recruit 698 (266 pretest; 432 main study) 
followers of an internet influencer who maintains an Instagram page 
with more than 500,000 followers and has posted about endometriosis. As 
in the first study, we are not revealing the influencer's identity to 
maintain the integrity of the study.
    In both studies, we are interested in the role of endorsement and 
payment status on participants' recall, benefit and risk perceptions, 
and behavioral intentions. Participants will view one promotional piece 
and answer questions via the internet. The study is expected to take 
less than 20 minutes to complete. Dependent variables will include 
attention to disclosure statement and risk/benefit information; 
retention of risk/benefit information; recognition of piece as 
promotion and endorser as paid; perceived benefits and risks, attitudes 
toward the product, endorser, and ad; and behavioral intentions such as 
asking a doctor about the drug.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 3--Estimated Annual Reporting Burden 1
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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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Study 1 Screener..............             933               1             933  0.08 (5 minutes)           74.64
Study 1 Pretest...............             249               1             249  0.33 (20                   82.17
                                                                                 minutes).
Study 1 Main test.............             405               1             405  0.33 (20                  133.65
                                                                                 minutes).
Study 2 Screener..............           1,417               1           1,417  0.08 (5 minutes)          113.36
Study 2 Pretest...............             266               1             266  0.33 (20                   87.78
                                                                                 minutes).
Study 2 Main test.............             432               1             432  0.33 (20                  142.56
                                                                                 minutes).
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    Total.....................  ..............  ..............  ..............  ................          634.16
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

II. 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. LaTour, C. and M. Smith, (1986). ``A Study of Expert 
Endorsement of OTC Pharmaceutical Products.'' Journal of 
Pharmaceutical Marketing & Management, 1(2), pp. 117-128.
    2. Bhutada, N.S. and B.L. Rollins (2015). ``Disease-Specific 
Direct-to-Consumer Advertising of Pharmaceuticals: An Examination of 
Endorser Type and Gender Effects on Consumers' Attitudes and 
Behaviors.'' Research in Social & Administrative Pharmacy, 11(6), 
pp. 891-910.
    3. Boerman, S.C., L.M. Willemsen, and E.P. Van Der Aa (2017). 
``This post is sponsored' Effects of Sponsorship Disclosure on 
Persuasion Knowledge and Electronic Word of Mouth in the Context of 
Facebook.'' Journal of Interactive Marketing, 38, pp. 82-92.

    Dated: January 21, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-01408 Filed 1-27-20; 8:45 am]
 BILLING CODE 4164-01-P