Agency Information Collection Activities; Proposed Collection; Comment Request; Promotion of Prescription Drugs Within a Talk Show Format, 80252-80255 [2024-22575]
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Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices
recommendations on supplemental
biologics license application 125586/
546 from AstraZeneca AB, submitted to
confirm the clinical benefit of Andexxa
(coagulation factor Xa (recombinant),
inactivated -zhzo), for patients treated
with rivaroxaban or apixaban when
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Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22561 Filed 10–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–3653]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Promotion of
Prescription Drugs Within a Talk Show
Format
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
SUMMARY:
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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 information
collection associated with a proposed
study entitled ‘‘Promotion of
Prescription Drugs Within a Talk Show
Format.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by
December 2, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
December 2, 2024. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
Electronic Submissions
Submit electronic comments in the
following way:
• 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
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Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices
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–
2024–N–3653 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Promotion of Prescription Drugs Within
a Talk Show Format.’’ 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
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-201509-18/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.
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FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAstaff@
fda.hhs.gov.
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.
Promotion of Prescription Drugs Within
a Talk Show Format
(OMB Control Number 0910—NEW)
This information collection request
supports Agency research authorized by
section 1701(a)(4) of the Public Health
Service Act (42 U.S.C. 300u(a)(4)) and
section 1003(d)(2)(C) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 393(d)(2)(C)).
The mission of the Office of
Prescription Drug Promotion (OPDP) is
to protect the public health by helping
to ensure that prescription drug
promotion is truthful, balanced, and
accurately communicated so that
patients and healthcare providers can
make informed decisions about
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treatment options. OPDP’s research
program provides scientific evidence to
help ensure that our policies related to
prescription drug promotion will have
the greatest benefit to public health.
Toward that end, we have consistently
conducted research to evaluate the
aspects of prescription drug promotion
that are most central to our mission,
focusing in particular on three main
topic areas: advertising features,
including content and format; target
populations; and research quality.
Through the evaluation of advertising
features, we assess how elements such
as graphics, format, and the
characteristics of the disease and
product impact the communication and
understanding of prescription drug risks
and benefits. Focusing on target
populations allows us to evaluate how
understanding of prescription drug risks
and benefits may vary as a function of
audience. Our focus on research quality
aims at maximizing the quality of
research data through analytical
methodology development and
investigation of sampling and response
issues. This study will inform the first
topic area, advertising features, by
examining a form of advertising known
as native advertising.
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-andresearch-cder/office-prescription-drugpromotion-opdp-research, which
includes links to the latest Federal
Register notices and peer-reviewed
publications produced by our office.
The objective of this present research
is to conduct experimental studies to
examine issues related to endorsers in
direct-to-consumer prescription drug
promotion that occurs within a talk
show format. This study complements
and builds upon two prior FDA studies
on endorsement issues (OMB control
numbers 0910–0894 and 0910–0918).
The first 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. The
second study extended the prior
research by examining, among other
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things, audience reactions to actual-use
disclosures (e.g., ‘‘actor portrayal’’
versus ‘‘actual patient’’) in a different
medium, television ads. The currently
proposed study will focus on endorsers
in a native advertising format (i.e., talk
show).
Native advertising is a form of
advertisement where marketers present
paid content in a format designed to
look and feel like the surrounding
media format and content in which it
appears (Refs. 1 and 2). Native
advertisements have become an
increasingly popular form of
advertising. In 2023, advertisers in the
United States were expected to spend
$97.46 billion on native display
advertising in all product categories
(showing a product in a combination of
image, text, and graphics), accounting
for 59.7 percent of total display
advertising spending (Ref. 2). The intent
of native advertising is to minimize the
disruption in the consumer’s regular
media intake experience (Ref. 3).
Recently, FDA has issued compliance
letters to pharmaceutical firms for
misleading promotion of prescription
drug products within talk show formats
(Refs. 11 and 12).
Research on the native advertising
format extends the theoretical
understanding of persuasion knowledge
(Refs. 4 to 6) and advertisement
recognition (Ref. 7) and has evaluated
policy implications around deceptive
advertising across different media
platforms (Refs. 8 and 9). However,
there has been less study of perceptions
and attitudes resulting from native
advertising, such as the impact on
viewer perceptions toward the product,
the advertisement, the endorser, or the
to extend our prior research on
endorsers in print and online promotion
(OMB control numbers 0910–0894 and
0910–0918) to native advertisements in
a talk show format. Another factor that
could affect whether viewers perceive a
native advertisement for a prescription
drug in a talk show format as
advertising is the prominence of the risk
disclosure. The two risk prominence
conditions will vary by lower or higher
prominence: (1) discussed in questionand-answer format during the interview
or (2) text scroll with voiceover after the
interview has concluded.
To ensure that the study is operating
as planned, we will conduct a pretest
prior to launching the main study. Both
the pretest and main study will use a 2
× 4 × 2 factorial design (table 1).
Through the use of an online survey,
each respondent will view 1 of 16
experimental variations of a fictitious
health-themed television show. This
base program will be consistent across
experimental conditions and will
feature content that blends health,
wellness, and lifestyle topics. The target
native advertisement segment will be
embedded between the base program
segments, varying across the three
independent variables.
Respondents will be recruited from
web panels and include those who have
been diagnosed with type 2 diabetes,
live in the United States, and are fluent
in English. Participation in the study is
voluntary. We will not select
respondents who work for the U.S.
Department of Health and Human
Services or a pharmaceutical,
advertising, or market research
company.
interaction of these factors (Ref. 10).
Moreover, the majority of research on
native advertising appears to focus on
advertorials in print or product
placement (Refs. 1 to 7). In the
literature, we did not find peerreviewed studies examining attitudes
and perceptions in reaction to native
advertising in a talk show format.
In the research described here, we
will investigate a native advertisement
for a fictitious prescription drug for type
2 diabetes embedded in a health-themed
television talk show. This examination
will help close the gap in the literature.
We will examine the impacts of three
independent variables—(1) sponsorship
prominence (none, once, periodic,
constant); (2) endorser type (the guest
on the talk show: patient, physician);
and (3) risk prominence (lower,
higher)—on the recall and
comprehension of risks and benefits
depicted in the advertisement,
perceptions of endorser characteristics,
perceptions of drug qualities, and
behavioral intentions. The four
sponsorship prominence conditions will
be: (1) no disclosure; (2) disclosure once
at the beginning of the segment ([GUEST
NAME] is a paid spokesperson for
DRUG X); (3) periodic disclosure at the
beginning, middle, and end of the
segment (A reminder that [GUEST
NAME] is a paid spokesperson for
DRUG X); and (4) constant disclosure in
text at the bottom of the screen through
the entire segment ([GUEST NAME] is a
paid spokesperson for DRUG X). The
two endorser type conditions will vary
by type of talk show guest: a patient or
a physician. Studying sponsorship
prominence and endorser type allows us
TABLE 1—STUDY EXPERIMENTAL DESIGN
Endorser type and risk prominence
Patient guest
Sponsorship prominence
Higher risk
prominence
Physician guest
Lower risk
prominence
Higher risk
prominence
Lower risk
prominence
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None.
Once.
Periodic.
Constant.
Following the video, respondents will
be asked questions pertaining to their
recall and comprehension of risks and
benefits depicted in the advertisement,
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perceptions of endorser characteristics,
perceptions of drug qualities, and
behavioral intentions.
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We estimate the burden of this
collection of information as follows:
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Federal Register / Vol. 89, No. 191 / Wednesday, October 2, 2024 / Notices
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average burden
per response 2
Total hours
Pretest
Pretest Screener Completes ..................................................................
Pretest Questionnaire Completes ..........................................................
400
80
1
1
400
80
0.03 (2 minutes) .........
0.30 (18 minutes) .......
12
24
Main Study
Main Study Screener Completes ...........................................................
Main Study Questionnaire Completes ...................................................
3,200
640
1
1
3,200
640
0.03 (2 minutes) .........
0.30 (18 minutes) .......
96
192
Total ................................................................................................
..........................
..........................
........................
.....................................
324
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
2 Burden
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References
The following references marked with
an asterisk (*) are on display at 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; 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.
Although FDA verified the website
addresses in this document, please note
that websites are subject to change over
time.
1. Wojdynski, B.W. and G.J. Golan, ‘‘Native
Advertising and the Future of Mass
Communication,’’ American Behavioral
Scientist, vol. 60, pp. 1403–1407, 2016,
https://doi.org/10.1177/
0002764216660134.
2. King, J., ‘‘Native Advertising: What It Is
and How It Benefits Advertisers and
Publishers,’’ EMARKETER, October 11,
2023. Available at: https://
www.emarketer.com/insights/native-adspending. Accessed on June 12, 2024.
3. Campbell, C. and L.J. Marks, ‘‘Good Native
Advertising Isn’t a Secret,’’ Business
Horizons, vol. 58, pp. 599–606, 2015,
https://doi.org/10.1016/
j.bushor.2015.06.003.
4. Campbell, C. and P.E. Grimm, ‘‘The
Challenges Native Advertising Poses:
Exploring Potential Federal Trade
Commission Responses and Identifying
Research Needs,’’ Journal of Public
Policy & Marketing, vol. 38, pp. 110–123,
2019, https://doi.org/10.1177/
0743915618818576.
5. Campbell, M.C. and A. Kirmani,
‘‘Consumers’ Use of Persuasion
Knowledge: The Effects of Accessibility
and Cognitive Capacity on Perceptions of
an Influence Agent,’’ Journal of
Consumer Research, vol. 27, pp. 69–83,
2000, https://doi.org/10.1086/314309.
6. Wei, M.-L., E. Fischer, and K.J. Main, ‘‘An
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Examination of the Effects of Activating
Persuasion Knowledge on Consumer
Response to Brands Engaging in Covert
Marketing,’’ Journal of Public Policy &
Marketing, vol. 27, pp. 34–44, 2008,
https://doi.org/10.1509/jppm.27.1.34.
7. Pierre, L., ‘‘The Effect of Covert
Advertising Recognition on Consumer
Attitudes: A Systematic Review,’’
Journal of Marketing Communications,
pp. 1–22, 2023, https://doi.org/10.1080/
13527266.2023.2184851.
8. Hastak, M. and M.B. Mazis, ‘‘Deception by
Implication: A Typology of Truthful but
Misleading Advertising and Labeling
Claims,’’ Journal of Public Policy &
Marketing, vol. 30, pp. 157–167, 2011,
https://www.jstor.org/stable/23209271.
9. Cain, R.M., ‘‘Embedded Advertising on
Television: Disclosure, Deception, and
Free Speech Rights,’’ Journal of Public
Policy & Marketing, vol. 30, pp. 226–238,
2011, https://doi.org/10.1509/
jppm.30.2.226.
10. Lee, S.S., H. Chen, and Y.-H. Lee, ‘‘How
Endorser-Product Congruity and SelfExpressiveness Affect Instagram MicroCelebrities’ Native Advertising
Effectiveness,’’ Journal of Product &
Brand Management, vol. 31, pp. 149–
162, 2022, https://www.emerald.com/
insight/content/doi/10.1108/JPBM-022020-2757/full/html.
*11. Untitled Letter to Aclaris Therapeutics,
Inc. (June 14, 2019). Available at: https://
www.fda.gov/media/128151/
download?attachment.
*12. Untitled Letter to Biohaven
Pharmaceuticals (March 8, 2021).
Available at: https://www.fda.gov/media/
146528/download?attachment.
Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–22575 Filed 10–1–24; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–1105]
Electronic Systems, Electronic
Records, and Electronic Signatures in
Clinical Investigations: Questions and
Answers; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Electronic Systems, Electronic
Records, and Electronic Signatures in
Clinical Investigations: Questions and
Answers.’’ The guidance provides
information for sponsors, clinical
investigators, institutional review
boards (IRBs), contract research
organizations (CROs), and other
interested parties on the use of
electronic systems, electronic records,
and electronic signatures in clinical
investigations of foods, medical
products, tobacco products, and new
animal drugs. The guidance provides
recommendations regarding the
requirements in our regulations,
pursuant to which FDA considers
electronic systems, electronic records,
and electronic signatures to be
trustworthy, reliable, and generally
equivalent to paper records and
handwritten signatures executed on
paper. This guidance finalizes the draft
guidance of the same title issued on
March 16, 2023, and supersedes the
guidance for industry entitled
‘‘Computerized Systems Used in
Clinical Investigations’’ issued in May
2007.
SUMMARY:
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]]>Agencies
[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80252-80255]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22575]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-3653]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Promotion of Prescription Drugs Within a Talk Show
Format
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection associated with a
proposed study entitled ``Promotion of Prescription Drugs Within a Talk
Show Format.''
DATES: Either electronic or written comments on the collection of
information must be submitted by December 2, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 2, 2024. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
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
[[Page 80253]]
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-2024-N-3653 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Promotion of Prescription Drugs
Within a Talk Show Format.'' 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 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: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[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.
Promotion of Prescription Drugs Within a Talk Show Format
(OMB Control Number 0910--NEW)
This information collection request supports Agency research
authorized by section 1701(a)(4) of the Public Health Service Act (42
U.S.C. 300u(a)(4)) and section 1003(d)(2)(C) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)).
The mission of the Office of Prescription Drug Promotion (OPDP) is
to protect the public health by helping to ensure that prescription
drug promotion is truthful, balanced, and accurately communicated so
that patients and healthcare providers can make informed decisions
about treatment options. OPDP's research program provides scientific
evidence to help ensure that our policies related to prescription drug
promotion will have the greatest benefit to public health. Toward that
end, we have consistently conducted research to evaluate the aspects of
prescription drug promotion that are most central to our mission,
focusing in particular on three main topic areas: advertising features,
including content and format; target populations; and research quality.
Through the evaluation of advertising features, we assess how elements
such as graphics, format, and the characteristics of the disease and
product impact the communication and understanding of prescription drug
risks and benefits. Focusing on target populations allows us to
evaluate how understanding of prescription drug risks and benefits may
vary as a function of audience. Our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform the first topic area, advertising features, by
examining a form of advertising known as native advertising.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved through the results
of multiple converging studies, we continue to develop evidence to
inform our thinking. We evaluate the results from our studies within
the broader context of research and findings from other sources, and
this larger body of knowledge collectively informs our policies as well
as our research program. Our research is documented on our home page at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
The objective of this present research is to conduct experimental
studies to examine issues related to endorsers in direct-to-consumer
prescription drug promotion that occurs within a talk show format. This
study complements and builds upon two prior FDA studies on endorsement
issues (OMB control numbers 0910-0894 and 0910-0918). The first 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. The
second study extended the prior research by examining, among other
[[Page 80254]]
things, audience reactions to actual-use disclosures (e.g., ``actor
portrayal'' versus ``actual patient'') in a different medium,
television ads. The currently proposed study will focus on endorsers in
a native advertising format (i.e., talk show).
Native advertising is a form of advertisement where marketers
present paid content in a format designed to look and feel like the
surrounding media format and content in which it appears (Refs. 1 and
2). Native advertisements have become an increasingly popular form of
advertising. In 2023, advertisers in the United States were expected to
spend $97.46 billion on native display advertising in all product
categories (showing a product in a combination of image, text, and
graphics), accounting for 59.7 percent of total display advertising
spending (Ref. 2). The intent of native advertising is to minimize the
disruption in the consumer's regular media intake experience (Ref. 3).
Recently, FDA has issued compliance letters to pharmaceutical firms for
misleading promotion of prescription drug products within talk show
formats (Refs. 11 and 12).
Research on the native advertising format extends the theoretical
understanding of persuasion knowledge (Refs. 4 to 6) and advertisement
recognition (Ref. 7) and has evaluated policy implications around
deceptive advertising across different media platforms (Refs. 8 and 9).
However, there has been less study of perceptions and attitudes
resulting from native advertising, such as the impact on viewer
perceptions toward the product, the advertisement, the endorser, or the
interaction of these factors (Ref. 10). Moreover, the majority of
research on native advertising appears to focus on advertorials in
print or product placement (Refs. 1 to 7). In the literature, we did
not find peer-reviewed studies examining attitudes and perceptions in
reaction to native advertising in a talk show format.
In the research described here, we will investigate a native
advertisement for a fictitious prescription drug for type 2 diabetes
embedded in a health-themed television talk show. This examination will
help close the gap in the literature. We will examine the impacts of
three independent variables--(1) sponsorship prominence (none, once,
periodic, constant); (2) endorser type (the guest on the talk show:
patient, physician); and (3) risk prominence (lower, higher)--on the
recall and comprehension of risks and benefits depicted in the
advertisement, perceptions of endorser characteristics, perceptions of
drug qualities, and behavioral intentions. The four sponsorship
prominence conditions will be: (1) no disclosure; (2) disclosure once
at the beginning of the segment ([GUEST NAME] is a paid spokesperson
for DRUG X); (3) periodic disclosure at the beginning, middle, and end
of the segment (A reminder that [GUEST NAME] is a paid spokesperson for
DRUG X); and (4) constant disclosure in text at the bottom of the
screen through the entire segment ([GUEST NAME] is a paid spokesperson
for DRUG X). The two endorser type conditions will vary by type of talk
show guest: a patient or a physician. Studying sponsorship prominence
and endorser type allows us to extend our prior research on endorsers
in print and online promotion (OMB control numbers 0910-0894 and 0910-
0918) to native advertisements in a talk show format. Another factor
that could affect whether viewers perceive a native advertisement for a
prescription drug in a talk show format as advertising is the
prominence of the risk disclosure. The two risk prominence conditions
will vary by lower or higher prominence: (1) discussed in question-and-
answer format during the interview or (2) text scroll with voiceover
after the interview has concluded.
To ensure that the study is operating as planned, we will conduct a
pretest prior to launching the main study. Both the pretest and main
study will use a 2 x 4 x 2 factorial design (table 1). Through the use
of an online survey, each respondent will view 1 of 16 experimental
variations of a fictitious health-themed television show. This base
program will be consistent across experimental conditions and will
feature content that blends health, wellness, and lifestyle topics. The
target native advertisement segment will be embedded between the base
program segments, varying across the three independent variables.
Respondents will be recruited from web panels and include those who
have been diagnosed with type 2 diabetes, live in the United States,
and are fluent in English. Participation in the study is voluntary. We
will not select respondents who work for the U.S. Department of Health
and Human Services or a pharmaceutical, advertising, or market research
company.
Table 1--Study Experimental Design
----------------------------------------------------------------------------------------------------------------
Endorser type and risk prominence
----------------------------------------------------------------
Patient guest Physician guest
Sponsorship prominence ----------------------------------------------------------------
Higher risk Lower risk Higher risk Lower risk
prominence prominence prominence prominence
----------------------------------------------------------------------------------------------------------------
None.
Once.
Periodic.
Constant.
----------------------------------------------------------------------------------------------------------------
Following the video, respondents will be asked questions pertaining
to their recall and comprehension of risks and benefits depicted in the
advertisement, perceptions of endorser characteristics, perceptions of
drug qualities, and behavioral intentions.
We estimate the burden of this collection of information as
follows:
[[Page 80255]]
Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pretest Screener Completes................... 400 1 400 0.03 (2 minutes)......................... 12
Pretest Questionnaire Completes.............. 80 1 80 0.30 (18 minutes)........................ 24
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main Study
--------------------------------------------------------------------------------------------------------------------------------------------------------
Main Study Screener Completes................ 3,200 1 3,200 0.03 (2 minutes)......................... 96
Main Study Questionnaire Completes........... 640 1 640 0.30 (18 minutes)........................ 192
----------------------------------------------------------------------------------------------------------
Total.................................... ............... ............... .............. ......................................... 324
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
References
The following references marked with an asterisk (*) are on display
at 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; 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. Although FDA verified the website addresses
in this document, please note that websites are subject to change over
time.
1. Wojdynski, B.W. and G.J. Golan, ``Native Advertising and the
Future of Mass Communication,'' American Behavioral Scientist, vol.
60, pp. 1403-1407, 2016, https://doi.org/10.1177/0002764216660134.
2. King, J., ``Native Advertising: What It Is and How It Benefits
Advertisers and Publishers,'' EMARKETER, October 11, 2023. Available
at: https://www.emarketer.com/insights/native-ad-spending. Accessed
on June 12, 2024.
3. Campbell, C. and L.J. Marks, ``Good Native Advertising Isn't a
Secret,'' Business Horizons, vol. 58, pp. 599-606, 2015, https://doi.org/10.1016/j.bushor.2015.06.003.
4. Campbell, C. and P.E. Grimm, ``The Challenges Native Advertising
Poses: Exploring Potential Federal Trade Commission Responses and
Identifying Research Needs,'' Journal of Public Policy & Marketing,
vol. 38, pp. 110-123, 2019, https://doi.org/10.1177/0743915618818576.
5. Campbell, M.C. and A. Kirmani, ``Consumers' Use of Persuasion
Knowledge: The Effects of Accessibility and Cognitive Capacity on
Perceptions of an Influence Agent,'' Journal of Consumer Research,
vol. 27, pp. 69-83, 2000, https://doi.org/10.1086/314309.
6. Wei, M.-L., E. Fischer, and K.J. Main, ``An Examination of the
Effects of Activating Persuasion Knowledge on Consumer Response to
Brands Engaging in Covert Marketing,'' Journal of Public Policy &
Marketing, vol. 27, pp. 34-44, 2008, https://doi.org/10.1509/jppm.27.1.34.
7. Pierre, L., ``The Effect of Covert Advertising Recognition on
Consumer Attitudes: A Systematic Review,'' Journal of Marketing
Communications, pp. 1-22, 2023, https://doi.org/10.1080/13527266.2023.2184851.
8. Hastak, M. and M.B. Mazis, ``Deception by Implication: A Typology
of Truthful but Misleading Advertising and Labeling Claims,''
Journal of Public Policy & Marketing, vol. 30, pp. 157-167, 2011,
https://www.jstor.org/stable/23209271.
9. Cain, R.M., ``Embedded Advertising on Television: Disclosure,
Deception, and Free Speech Rights,'' Journal of Public Policy &
Marketing, vol. 30, pp. 226-238, 2011, https://doi.org/10.1509/jppm.30.2.226.
10. Lee, S.S., H. Chen, and Y.-H. Lee, ``How Endorser-Product
Congruity and Self-Expressiveness Affect Instagram Micro-
Celebrities' Native Advertising Effectiveness,'' Journal of Product
& Brand Management, vol. 31, pp. 149-162, 2022, https://www.emerald.com/insight/content/doi/10.1108/JPBM-02-2020-2757/full/html.
*11. Untitled Letter to Aclaris Therapeutics, Inc. (June 14, 2019).
Available at: https://www.fda.gov/media/128151/download?attachment.
*12. Untitled Letter to Biohaven Pharmaceuticals (March 8, 2021).
Available at: https://www.fda.gov/media/146528/download?attachment.
Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22575 Filed 10-1-24; 8:45 am]
BILLING CODE 4164-01-P
