[Federal Register Volume 85, Number 235 (Monday, December 7, 2020)]
[Notices]
[Pages 78859-78865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26799]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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, Agency, or we) 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 January 6, 2021.

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 
Comment'' or by using the search function. The title of this 
information collection is ``Endorser Status and Explicitness of Payment 
in Direct-to-Consumer Promotion.'' Also include the FDA docket number 
found in brackets in the heading of this document.

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, 
<a href="/cdn-cgi/l/email-protection#beeeecffedcadfd8d8fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="c595978496b1a4a3a385a3a1a4ebadadb6eba2aab3">[email protected]</span></a>.
    For copies of the questionnaires contact: Office of Prescription 
Drug Promotion (OPDP) Research Team, <a href="/cdn-cgi/l/email-protection#387c6c7b4a5d4b5d594a5b50785e5c591650504b165f574e"><span class="__cf_email__" data-cfemail="02465641706771676370616a426466632c6a6a712c656d74">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 
promotion 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. Our research focuses 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

[[Page 78860]]

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 our 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 is improved by utilizing 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 survey on direct-to-
consumer (DTC) advertisements 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 endorsers truly believe 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 endorsements by expert physicians and pharmacists were the most 
likely to lead to purchase intentions, followed by endorsements by 
consumers, and lastly, by celebrities. The type of OTC product did not 
affect the persuasiveness of an endorsement.
    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 
endorsement by experts resulted in greater consumer intention to pursue 
the drug product.
    We propose to extend previous research by examining four types of 
endorsers in two separate studies (celebrity, physician, patient, non-
celebrity 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\ A ``non-celebrity influencer'' is a person who has gained a 
following on a blog, a Twitter feed, or other social media outlet. 
In the 60-day notice, the term ``influencer'' was used; we have 
added language to specify influencers who were not previously 
celebrities before their social media activities.
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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 1

                                        Table 1a--Study 1 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                     Endorser
               Payment disclosure                ------------------------------------------------      Total
                                                     Celebrity       Physician        Patient
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Present.........................................              50              50              50             150
Absent..........................................              33              33              33              99
                                                 ---------------------------------------------------------------
    Total.......................................              83              83              83             249
----------------------------------------------------------------------------------------------------------------


                                      Table 1b--Study 1 Design--Main Study
                                [0.90 power, 0.05 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                     Endorser
               Payment disclosure                ------------------------------------------------      Total
                                                     Celebrity       Physician        Patient
----------------------------------------------------------------------------------------------------------------
Present.........................................              81              81              81             243
Absent..........................................              54              54              54             162
                                                 ---------------------------------------------------------------
    Total.......................................             135             135             135             405
----------------------------------------------------------------------------------------------------------------

    Study 1 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 the Kantar Lightspeed national nonprobability 
internet panel. 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

[[Page 78861]]

testing but will be similar to: ``[Endorser] has been paid to appear in 
this ad for Drug X.''

Study 2

                                        Table 2a--Study 2 Design--Pretest
                                [0.80 power, 0.10 alpha, small effect size f=.2]
----------------------------------------------------------------------------------------------------------------
                                                                             Endorser
                       Payment disclosure                        --------------------------------      Total
                                                                    Influencer        Patient
----------------------------------------------------------------------------------------------------------------
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]
----------------------------------------------------------------------------------------------------------------
                                                                             Endorser
                       Payment disclosure                        --------------------------------      Total
                                                                    Influencer        Patient
----------------------------------------------------------------------------------------------------------------
Present-Direct..................................................              81              81             162
Present-Indirect................................................              81              81             162
Absent..........................................................              54              54             108
                                                                 -----------------------------------------------
    Total.......................................................             216             216             432
----------------------------------------------------------------------------------------------------------------

    In Study 2, 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, resulting in a 2 (endorser: Influencer, patient) by 
3 (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 1 and 
extends it by further examining the explicitness of payment as another 
manipulated variable and using a different set of endorser types and in 
a different promotional setting.
    For Study 2, 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 in 
this public forum to maintain the integrity of the study.
    In both studies, we are interested in the role of endorsement and 
disclosure of 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.
    In the Federal Register of January 28, 2020 (85 FR 4994), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received six submissions that were PRA-
related. One submission (https://www.regulations.gov/docketBrowser?rpp=25&po=0&dct=PS&D=FDA-2019-N-5900&refD=FDA-2019-N-5900-0001) was a brief statement of support for the research and is not 
addressed further. Within the remaining five submissions, FDA received 
multiple comments that the Agency has addressed below. For brevity, 
some public comments are paraphrased and, therefore, may not reflect 
the exact language used by the commenter. We assure commenters that the 
entirety of their comments was considered even if not fully captured by 
our paraphrasing in this document. The following acronyms are used 
here: DTC = direct-to-consumer; FDA and ``The Agency'' = Food and Drug 
Administration; OPDP = FDA's Office of Prescription Drug Promotion; and 
FTC = Federal Trade Commission.
    (Comment 1) One comment suggested that the proposed research, at 
least in part, is duplicative of information otherwise reasonably 
available to FDA. The comment pointed out that the Notice cites three 
scientific references, and it does not address the other literature 
that exists on the subject of endorsers in advertising. The comment 
recommended that FDA assemble and review the relevant literature on 
endorsement to ensure the research questions have not already been 
answered.
    (Response) A literature review was conducted as part of this 
project that identified relevant literature. We identified a 
significant gap in the literature regarding the impact of social media 
influencers in prescription drug DTC advertisements, as well as a lack 
of information about the impact of explicit payment disclosure. The 
research questions outlined in our proposed research were designed to 
address this gap.
    (Comment 2) One comment suggested that, although the studies 
contain clear variables, they appear to lack clearly defined primary 
outcomes and prespecified hypotheses for testing. The comment also 
noted that the studies do not appear to be designed to account for Type 
I error; thus, the results may be uninterpretable. The comment 
recommended that FDA propose a primary endpoint for each study and 
power each study to test it.
    (Response) Specific hypotheses have been developed for each of the 
outcome variables, as described earlier in the notice. We will adjust 
for multiple comparisons using the Bonferroni correction.

[[Page 78862]]

    (Comment 3) One comment suggested that it is unclear how FDA came 
up with the proposed sample sizes for the two related studies. For 
example, the comment stated that the chart for pretest 1 contains the 
following notation: ``(0.80 power, 0.10 alpha, small effect size 
f=.2),'' but it is unclear what f=.2 means in this context. The comment 
requested that FDA explain what statistical model it used to estimate 
the study size and how it determined that the relevant effect size is 
.2.
    (Response) f=.2 is a common standard used to calculate small effect 
size in experimental studies (Ref. 4). We used G*Power to estimate 
study size (Ref. 5).
    (Comment 4) One comment suggested that the proposed research is 
unnecessary to the proper performance of FDA's functions because the 
FTC takes the lead on regulating endorsement. The comment stated that 
FDA has not addressed the extensive framework and guidance available 
from the FTC on this topic. The comment further stated that, although 
use of an endorser might conceivably inform an assessment of whether 
advertising or promotion is false or misleading, it is not clear how 
FDA views this new research on endorser status as fitting into its core 
regulatory jurisdiction or activities.
    (Response) FDA and the FTC have a long history of working 
collaboratively to protect American consumers. While the FTC does 
regulate endorsement in many types of commercial advertisements, FDA 
has authority to regulate prescription drug advertising with respect to 
the safety and effectiveness of such drugs. In line with FDA's 
responsibility to ensure that prescription drug advertising and other 
promotional communications are truthful and non-misleading, the present 
research will provide data on how elements related to endorsement 
presentations in prescription drug promotion impact audience perception 
and comprehension. Collecting this data is critical to FDA's science-
based approach to assessing prescription drug promotion to determine 
whether it communicates information about prescription drugs to 
consumers in a truthful, non-misleading way. We note that as part of 
the process of developing the present research, FDA carefully evaluated 
the FTC guidance on endorser issues.
    (Comment 5) One comment recommended that alignment and input should 
be obtained from the FTC regarding the design of the study and 
usability of the results.
    (Response) We evaluated the current FTC guidance on endorsement 
disclosure when developing this study and all relevant elements of its 
design, including our hypotheses, test stimuli, etc.
    (Comment 6) One comment suggested that the research may be skewed 
by the influence of a particular celebrity. The comment recommended 
that the study be amended so it is not subject to bias by the influence 
of one particular well-known celebrity.
    (Response) Familiarity with an endorser has shown to be an 
important factor in attention to DTC advertisements, but the evidence 
is less strong that familiarity uniquely affects other outcomes such as 
behavioral intention (see, for example, Refs. 2 and 6). The celebrity 
used in Study 1 will have high levels of public recognition, so we 
anticipate few participants will be filtered out due to low levels of 
familiarity with endorser. We recognize that the individual 
characteristics of the celebrity may drive responses. This possibility 
is an unavoidable limitation of the study design, and we will be 
transparent when reporting results.
    (Comment 7) One comment recommended that FDA use #ad instead of 
#sp. The comment noted that FTC has stated that #ad is an effective 
disclosure of sponsorship.
    (Response) Our review of current practices shows that vendors 
continue to indicate endorsement by #sp online. An indirect disclosure 
such as #sp serves as a useful comparator to a direct disclosure such 
as ``Paid ad. . .'', helping us answer the research question of whether 
direct and indirect acknowledgements of endorsement vary in their 
influence on attitudes and perceptions.
    (Comment 8) One comment recommended that FDA incorporate some type 
of control into each study.
    (Response) We have designed these studies to include a control. The 
control, in both studies, is a duplicate version of the promotion 
featuring endorsement by a patient, as opposed to a celebrity or 
influencer, without inclusion of a payment disclosure.
    (Comment 9) One comment suggested that FDA should ensure that the 
hypothetical products used in the proposed surveys do not too closely 
resemble real products. For example, the conditions of use and the risk 
of the hypothetical products should not mirror FDA-approved labeling 
language for any marketed products. In addition, FDA should only 
present hypothetical drug advertisements for diseases with many 
treatment options from multiple sponsors. Otherwise, the comment states 
that FDA's research could inadvertently harm one particular sponsor.
    (Response) The prescription drugs used in this study, while based 
on existing prescription treatments, are fictitious with names and 
branding that do not mirror any marketed products. Although we have 
created the pieces to be as realistic as possible, FDA does not intend 
to single out any real product on the basis of our fictional promotion. 
We specifically use fictitious products and materials to avoid the 
confound of prior knowledge of actual products. Moreover, it is the 
endorser type and messaging around the endorsement disclosure that are 
being investigated. The fictional drug is not a study variable and 
therefore is held constant.
    (Comment 10) One comment suggested that the route of drug 
administration may influence the participants' responses, as oral 
administration and inhaled medication is preferable compared to 
injections. Therefore, the comment suggested that the study use 
fictitious drugs with routes of administration that are similar to top 
advertised DTC prescription drugs.
    (Response) This is outside the scope of study objectives. The goal 
of the studies is to understand the effect of endorsement and payment 
disclosure on perceived risks and benefits of DTC promotion. Because 
the same drug is being presented in each experimental condition, the 
effects of mode of administration are being held constant in each 
study; therefore, any observed effects are not related to the route of 
administration chosen.
    (Comment 11) One comment suggested that in order to increase 
internal validity, the location of the disclosures in the promotional 
pieces should be consistent across endorser and/or disclosure type.
    (Response) FDA will ensure that for each study, disclosures will 
appear in the same area of the promotional piece, using similar font 
and style treatment.
    (Comment 12) One comment suggested that acne and endometriosis 
drugs are not representative of the top advertised prescription drugs 
and that the current proposed study design, therefore, may not 
represent the most advertised DTC drugs in the market.
    (Response) The purpose of the studies is to understand the effect 
of endorsement and payment disclosure on perceived risks and benefits 
of DTC promotion. The value of our approach is random assignment to 
experimental conditions and control of extraneous variables. Choice of 
drug is not a study variable and therefore held constant. Although the 
type of drug may play a

[[Page 78863]]

role in the perceptions of risks and benefits, the value of our study 
is the comparisons between experimental conditions.
    (Comment 13) Two comments suggested that participants' 
unfamiliarity with the proposed conditions may bias their responses, so 
it may be more useful to include only patients with the condition as 
participants in each study.
    (Response) The study population is those who are exposed to 
prescription drug advertisements. For Study 1, we chose a high 
incidence condition (acne) so that it would be relatable to a large 
segment of the population. Regardless of whether or not the condition 
is personally salient, the public is still exposed to these 
advertisements.
    For Study 2, we chose a condition that is important to the 
influencer in the study--and this information would be known to many of 
her followers, who are the research audience for Study 2. Engagement 
and e-Word of Mouth have been shown to be important behavioral outcomes 
from social media promotion (Ref. 3). Thus, in a real-world setting, 
audience members may choose to comment on or share the advertised 
content with family or friends, regardless of whether or not they have 
the health condition themselves.
    For both studies, we ask about personal experience and involvement 
with the health condition, and we will assess whether these variables 
have any effects.
    (Comment 14) One comment suggested ensuring that neutral language 
is used when recruiting for Study 1's general population, so as not to 
select for participants that are more susceptible to the celebrity's 
influence. For example, the comment suggested that the study ask 
participants if they ``recognize'' the celebrity vs. if they are a 
``fan'' of the celebrity.
    (Response) In screeners for both studies, we ask if participants 
are ``familiar'' with celebrities/influencers, thus maintaining neutral 
language.
    (Comment 15) Two comments suggested participants' familiarity with 
the endorser may bias responses and limit participant demographics. One 
comment suggested that recruiting participants from the follower list 
of an Instagram influencer, as proposed in Study 2, may skew the 
average age of the participants to be younger, especially if the 
influencer chosen for this study is a ``handheld name'' versus a 
``household name.'' The comment also suggested that the participants 
may have a female skew. Another comment suggested that the current 
inclusion criteria should be expanded to also include followers of 
influencers with similar content, recognition, and follower 
demographics as the endorser being tested, which will increase external 
validity by encompassing viewers that would likely see the post through 
suggestions via Instagram's algorithm.
    (Response) Familiarity with an endorser has been shown to be an 
important factor in attention given to DTC advertisements (Ref. 2), and 
that is one driver of an influencer's value as an endorser. By 
including endorser type as an experimental condition, we seek to 
isolate these effects. Thus, the biases inherent in these relationships 
are a necessary aspect of this topic area.
    The study design is a between-subjects design. Because participants 
are only exposed to one promotional piece, the specific effects from 
behavioral bias can be isolated.
    We agree with the commenter that Study 2 will have a younger, 
female skew. This is consistent with Instagram's audience more 
generally (Ref. 7). Advertisers who use Instagram influencers as 
endorsers will access the same audience (i.e., Instagram followers) as 
in our study. To minimize confounds, we will limit the sample to the 
influencer's followers, who are likely to be the most influenced by 
her. Future research can be conducted on whether our findings 
extrapolate to men and older audiences.
    (Comment 16) One comment suggested that to account for the 
potential bias in these studies, it would be useful to include 
questions relating to participant demographics in the surveys, such as 
age, gender, and attitude toward the celebrity or influencer, if they 
are not already included.
    (Response) The survey includes questions about participant 
demographics and attitude toward endorser.
    (Comment 17) One comment suggested that in order to prevent bias, 
the study should exclude consumers who work in healthcare or marketing 
settings, primary care providers that spend less than 50 percent of 
their time on patient care, and Department of Health and Human Service 
employees.
    (Response) The studies in this research do not include physician 
participants. Consumers will be excluded if they work for a 
pharmaceutical company, an advertising agency, a market research firm, 
or the U.S. Department of Health and Human Services. They will also be 
screened out if they are not familiar with the celebrity/influencer, 
and, for Study 2, if they are biologically male, as men cannot have 
endometriosis.
    (Comment 18) One comment suggested that the questionnaire is too 
long and recommended deleting questions or rewording.
    (Response) We have had individuals unfamiliar with the study test 
the survey for length, and we found it takes less than 20 minutes to 
complete. Moreover, we will also conduct pretesting to check timing and 
make adjustments, if necessary, based on the data from those pretests.
    (Comment 19) One comment suggested we should consistently use 
balanced Likert scales with a neutral midpoint.
    (Response) This is a matter of debate in the literature and has 
never been resolved. Many of our measures derive from previously 
validated scales, and we prefer to maintain the scales on which they 
were validated. However, where appropriate, we do use 5-point Likert 
scales with a neutral midpoint.
    (Comment 20) One comment recommended rewording Q17 (in both study 
questionnaires) to state ``What do you remember about the safety 
information presented?''
    (Response) Q17 is a validated (OMB control number 0910-0861) 
closed-ended item asking how much risk information was read (with a 
thumbnail image highlighting the important safety information). In 
order to increase quality of response, we will keep the closed-ended 
item. Moreover, open-ended questions take longer to answer, and we want 
to maintain an appropriate length of time to complete the survey.
    (Comment 21) One comment suggested that the adjectives that the 
respondent is asked to rank in Q18a-Q18e (Study 1) are redundant with 
only nuanced differences that may not be distinguishable to 
respondents, and therefore suggested these items be deleted. If they 
are retained, the comment suggested labeling answer choice #3 with 
``Neither unimportant nor important.''
    (Response) These items were adapted from Zaichowsky's Disease State 
Involvement scale (Ref. 8). The original validated items used a 7-point 
scale without a labeled midpoint. To be consistent with most of the 
items and with previous comments, we reduced the scale to 5 points. 
However, we did not include a labeled midpoint because it could result 
in under-response for values 2 and 4. This response applies to Q20 
(Study 2) as well, where we want to ensure that individuals taking 
Study 2 on their mobile devices are not overwhelmed.

[[Page 78864]]

    (Comment 22) One comment suggested that Q20 and Q21 (Study 1) may 
be redundant, and since Q20 uses more consumer-friendly language to 
seek respondent opinion on effectiveness of drug, the comment 
recommended removing Q21. This comment also applies to Q22 and Q23 of 
Study 2.
    (Response) We will remove Q21 (Study 1) and Q23 (Study 2).
    (Comment 23) One comment recommended that Q22 (Study 1) be framed 
differently to help understand how endorsers influence the 
understanding of safety and risk and that the answer choice should have 
an option for respondents who do not know.
    (Response) We decline to make the recommended change because this 
is a validated item that FDA has used in past survey experiments to 
measure perceived risk likelihood.
    (Comment 24) One comment questioned the utility of asking whether 
an endorser is ``Attractive,'' ``Classy,'' and ``Elegant'' (Q30, Study 
1); whether a drug name and endorser name ``go together'' (Q31, Study 
1); and how a subject feels about the life and values of the endorser 
(Q32, Study 1). The comment recommended that FDA consider deleting 
these questions.
    (Response) In the marketing literature on celebrity endorsements, 
these three elements are well established as important moderators in 
attitude toward advertisement and behavioral intention. ``Attractive,'' 
``Classy,'' and ``Elegant'' are elements in a 15-item scale validated 
by Ohanian (1990) to measure endorser credibility (Ref. 9). The 
literature refers to ``whether a drug name and endorser go together'' 
as ``product match-up'' (Ref. 10), and high match-up was recently shown 
to be predictive of behavioral intention for e-cigarettes (Ref. 11). 
The level of identification that consumers have with a celebrity 
endorser has been shown to influence how consumers attend to and 
process information in an advertisement (Refs. 12 and13). Thus, we will 
maintain these questions.
    (Comment 25) One comment suggested that, if the research is 
intended to assess the influence of endorsers or their payment status, 
Q15-Q17 in both surveys and Q20-Q27 for Study 1 and Q22-Q29 for Study 2 
appear to be outside of the scope. With these questions, subjects would 
be asked to assess the risks and benefits of a drug based on an 
advertisement. The comment recommended that FDA delete these questions 
or revise them so they are focused instead on payment or endorsement.
    (Response) As part of the examination of the effect of the 
endorser, one purpose of the study is to understand the effect of 
endorsement and payment disclosure in DTC promotion on perceived risks 
and benefits of a prescription drug. The questions mentioned in this 
comment measure these dependent variables--consumer perceptions of risk 
and benefit information presented in the promotion. We will maintain 
these questions in order to assess if endorsement and the payment 
disclosure have any effects on perceptions of risk and benefit 
information.
    (Comment 26) One comment suggested that the structure of Q28 (Study 
1) and Q30 (Study 2) should be consistent with other questions in this 
survey. It recommended changing each question to include ``What is the 
likelihood'' (e.g., What is the likelihood that you would ask your 
doctor to prescribe) and presenting answer choices in a 5-point Likert 
scale.
    (Response) We will assess how this item functions in pretesting and 
make any change that is warranted.
    (Comment 27) One comment suggested moving Q28a (Study 1) and Q30a 
(Study 2) up in the survey, after Q13, as this question could function 
as a priming question after initial viewing of ad.
    (Response) Because this item is part of a validated scale (Ref. 
14), we will maintain it at its current location in both surveys.
    (Comment 28) One comment suggested that Q31 (Study 1) and Q33 
(Study 2) construct and answer choices should align with other 
similarly constructed question and answer choices in this section of 
the survey.
    (Response) This is a validated item (Ref. 15) to measure endorser-
product match-up. Therefore, we will maintain the current format.
    (Comment 29) One comment suggested that Q33 (Study 1) and Q35 
(Study 2) could cause respondent confusion regarding what is meant by 
``background,'' which could lead to uninterpretable results. It 
recommended explicitly stating what is meant by ``background'' (e.g., 
``I prefer a product recommended by an endorser because of his/her 
experience with this illness'').
    (Response) This is a validated item (Ref. 16) that measures 
identification with endorser; thus, we will maintain its original form 
in both studies.
    (Comment 30) One comment mentioned that Q43-Q45 (Study 1) and Q45-
Q47 (Study 2) probe the level of influence that endorsers have over 
respondents and suggested adding a question asking if the respondent 
has followed the advice of an endorser.
    (Response) Q36-Q48 (Study 1) and Q45-47 (Study 2) are validated 
items in the celebrity-persona parasocial-involvement scale (Ref. 17); 
thus, we will maintain the integrity of the scale and not add another 
question in this series.
    (Comment 31) One comment suggested that the debriefing statements 
in both questionnaires may serve the respondent better if placed 
earlier in the document as a disclaimer and suggested placing the 
disclaimer language prior to showing the promotional piece.
    (Response) To maximize the attention participants give to this 
survey task, we do not wish to inform them of the information in the 
debriefing statement until they have completed the survey.
    (Comment 32) One comment suggested that Q18 and Q19 (Study 2) are 
redundant, although respondents may not define a paid endorser post as 
advertising, and that the items seem irrelevant. It recommended 
removing Q18 from the questionnaire.
    (Response) Previous experimental studies on social media promotion 
have found that participants did not consistently notice a payment 
disclosure or interpret a sponsored post as advertising (Ref. 1). These 
issues are central to the question of whether consumers process payment 
disclosures. Moreover, participants in cognitive testing distinguished 
between the two items.
    (Comment 33) One comment noticed that Q20 in Study 2 is similar to 
Q18 in Study 1; however, answer choices are not provided in a similar 
construct. The comment recommended utilizing a 5-point Likert scale to 
measure the outcome.
    (Response) We simplified the response scale for Study 2 items, 
where possible, to account for anticipated higher usage of mobile 
devices. Because we prefer a larger number of response options in 
general, we plan to maintain the 5-point Likert scale for Study 1, but 
use the 3-point scale in Study 2 to account for mobile devices.
    (Comment 34) One comment suggested that Q24 (Study 2) could be 
framed differently to help understand how endorsers influence the 
understanding of safety and risk. The comment recommended asking ``Do 
you recall the risk associated with the medication?'' and suggested 
that the answer choice should have an option for respondents who do not 
know.
    (Response) Q24 and Q25 from Study 2 are closed-ended questions that 
ask about recall of drug benefits and risks. To be balanced, the 
question stem and

[[Page 78865]]

response options should be parallel between the two items. Moreover, we 
cannot add additional open-ended questions to the survey without 
increasing participant fatigue. Thus, we will maintain the closed-ended 
nature of the question. We recognize that this will be a difficult 
question for participants, and therefore, we prefer not to provide an 
option for ``don't know.''
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                   Number of
           Activity                Number of     responses per   Total annual    Average burden     Total hours
                                  respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
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).
                               ---------------------------------------------------------------------------------
    Total.....................  ..............  ..............  ..............  ................          634.16
----------------------------------------------------------------------------------------------------------------
\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 (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852, 240-402-7500, 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, vol. 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, vol. 11(6), 
pp. 891-900.
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, vol. 38, pp. 82-92.
4. Cohen, J. (1988), ``Statistical Power Analysis for the Behavioral 
Sciences.'' Routledge. ISBN 978-1-134-74270-7.
5. Faul, F., E. Erdfelder, A.G. Lang, et al. (2007). ``G*Power 3: A 
Flexible Statistical Power Analysis Program for the Social, 
Behavioral, and Biomedical Sciences.'' Behavior Research Methods, 
vol. 39, pp. 175-191.
6. Woods, C.B., S. Baxter, E. King, et al. (2017). ``Celebrity? 
Doctor? Celebrity doctor? Which Spokesperson Is Most Effective for 
Cancer Prevention?'' In E. Kendal and B. Diug (Eds.) Teaching 
Medicine and Medical Ethics Using Popular Culture (pp. 71-98). 
Palgrave Studies in Science and Popular Culture. Cham, Switzerland: 
Palgrave Macmillan. doi:10.1007/978-3-319-65451-5_5.
7. https://www.statista.com/statistics/398166/us-instagram-user-age-distribution/.
8. Zaichkowsky, J.L. (1994). ``The Personal Involvement Inventory: 
Reduction, Revision, and Application to Advertising.'' Journal of 
Advertising, vol. 23(4), pp. 59-70.
9. Ohanian, R. (1990). ``Construction and Validation of a Scale to 
Measure Celebrity Endorsers' Perceived Expertise, Trustworthiness, 
and Attractiveness.'' Journal of Advertising, vol. 19(3), pp. 39-52.
10. Kamins, M.A. and K. Gupta (1994). ``Congruence Between 
Spokesperson and Product Type: A Matchup Hypothesis Perspective.'' 
Psychology & Marketing, vol. 11(6), pp. 569-586.
11. Phua, J., J.S.E. Lin, and D.J. Lim (2018). ``Understanding 
Consumer Engagement with Celebrity-Endorsed E-Cigarette Advertising 
on Instagram.'' Computers in Human Behavior, vol. 84, pp. 93-102.
12. Brown, W.J. and M.C. Bocarnea (2007). ``Celebrity-Persona 
Interaction Scale.'' In R.A. Reynolds, R. Woods, and J.D. Baker 
(Eds.) Handbook of Research on Electronic Surveys and Measurements 
(pp. 302-305). Hershey, PA: Idea Group Reference.
13. Brown, W.J. and M.A.C. De Matviuk (2010). ``Sports Celebrities 
and Public Health: Diego Maradona's Influence on Drug Use 
Prevention.'' Journal of Health Communication, vol. 15(4), pp. 358-
373.
14. Huh, J., D.E. DeLorme, and L.N. Reid (2005). ``Factors Affecting 
Trust in On-Line Prescription Drug Information and Impact of Trust 
on Behavior Following Exposure to DTC Advertising.'' Journal of 
Health Communication, vol. 10(8), pp. 711-731.
15. Till, B.D. and M. Busler (2000). ``The Match-Up Hypothesis: 
Physical Attractiveness, Expertise, and the Role of Fit on Brand 
Attitude, Purchase Intent and Brand Beliefs.'' Journal of 
Advertising, vol. 29(3), pp. 1-13.
16. Biswas, D., A. Biswas, and N. Das (2006). ``The Differential 
Effects of Celebrity and Expert Endorsements on Consumer Risk 
Perceptions: The Role of Consumer Knowledge, Perceived Congruency, 
and Product Technology Orientation.'' Journal of Advertising, vol. 
35(2), pp. 17-31.
17. Bocarnea, M.C. and W.J. Brown (2007). ``Celebrity-Persona 
Parasocial Interaction Scale.'' In R.A. Reynolds, R. Woods, and J.D. 
Baker (Eds.) Handbook of Research on Electronic Surveys and 
Measurements (pp. 309-312). Hershey, PA: Idea Group Reference.

    Dated: December 1, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-26799 Filed 12-4-20; 8:45 am]
BILLING CODE 4164-01-P


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