Agency Information Collection Activities; Proposed Collection; Comment Request; Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion

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Published

December 21, 2023

Issuing agencies

Health and Human Services DepartmentFood and Drug Administration

Abstract

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled "Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion."

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<title>Federal Register, Volume 88 Issue 244 (Thursday, December 21, 2023)</title>
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[Federal Register Volume 88, Number 244 (Thursday, December 21, 2023)]
[Notices]
[Pages 88398-88401]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-28093]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-4201]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Examination of Implied Claims in Direct-to-Consumer
Prescription Drug Promotion

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Examination of Implied
Claims in Direct-to-Consumer Prescription Drug Promotion.''

DATES: Either electronic or written comments on the collection of
information must be submitted by February 20, 2024.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 20, 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets

[[Page 88399]]

Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-4201 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Examination of Implied Claims in
Direct-to-Consumer Prescription Drug Promotion.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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: Jonna Capezzuto, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#86d6d4c7d5f2e7e0e0c6e0e2e7a8eeeef5a8e1e9f0"><span class="__cf_email__" data-cfemail="1a4a485b496e7b7c7c5a7c7e7b34727269347d756c">[email&#160;protected]</span></a>. The draft survey instrument is available upon
request from <a href="/cdn-cgi/l/email-protection#bffbebfccddaccdadecddcd7ffd9dbde91d7d7cc91d8d0c9"><span class="__cf_email__" data-cfemail="4d09190e3f283e282c3f2e250d2b292c6325253e632a223b">[email&#160;protected]</span></a>.

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.

Examination of Implied Claims in Direct-to-Consumer Prescription Drug
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 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 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 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 homepage at
<a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research</a>, which includes links
to the latest Federal Register notices and peer-reviewed publications
produced by our office.
Direct-to-consumer (DTC) prescription drug promotion may include
truthful and non-misleading claims about the product. A particular
claim may be direct (explicit) or indirect (implied or implicit). Some
prior

[[Page 88400]]

research has shown that implied claims are misremembered as explicit
claims (Ref. 1). Other research has shown that claims can result in a
misleading impression of the product through implication, rather than
literal interpretation (Ref. 2). Understanding how consumers who self-
report having been diagnosed with a target condition interpret implied
claims in DTC prescription drug promotion--and how their perceptions
differ from those of consumers who have not been diagnosed with the
target condition--will provide valuable insight into the relevance and
impact of various product attributes and promotional claims on
treatment decisions.
The current project will test the impact of several implied claims
in DTC prescription drug advertising on consumer perceptions. The
project has two phases: experimental and conjoint analysis. In the
experimental phase, participants will view one version of a DTC
television ad containing both explicit and one of four implicit product
claims of interest or a control ad containing only explicit claims, and
be asked their impressions of the product's risks, benefits, and other
attributes. In the conjoint analysis phase, we will conduct a best-
worst scaling (BWS) experiment to elicit the relative importance of
various characteristics of immunotherapies indicated to treat patients
with advanced melanoma, including several implied claims. For this
study, we will use an object case design, which does not require us to
manipulate different levels of the characteristics included in the
design. Participants will be shown a series of choice tasks that are
each made up of different subsets of an experiment-wide list of
characteristics. Each participant will complete several tasks, and will
be asked to first select which one they would care about the most if
they were considering an immunotherapy, followed by the characteristic
they would care about the least.
We are proposing to include 13 characteristics in our BWS
experiment. Each task will include only four of those characteristics,
the combination of which will be drawn from a balanced incomplete block
design (BIBD; see Ref. 3). A BIBD ensures that (1) each task contains
the same number of characteristics; (2) each characteristic occurs the
same number of times across tasks; and (3) each pair of characteristics
is shown to participants the same number of times over the entire
experiment. These three properties are desirable for meeting estimation
assumptions (e.g., balance and orthogonality). An additional (and
unique) favorable property of including 13 characteristics in the
experiment is that BIBDs exist that yield 13 tasks with 4
characteristics per task. Thirteen is a manageable number of tasks for
a single participant to complete, and as a result, the full
experimental design will be replicated by each participant.
We estimate that participation in the study will take approximately
20 minutes. Adult voluntary participants aged 18 years or older will be
recruited by email through an internet panel, and participant
eligibility will be determined with a screener at the beginning of the
online survey. We will exclude individuals who work in healthcare
settings, employees of the Department of Health and Human Services, or
individuals who work in the marketing, advertising, or pharmaceutical
industries. Half the sample will consist of individuals who self-
identify as cancer survivors, excluding survivors of certain
nonmelanoma skin cancers.
The target sample size for the experimental phase is 1,030 adults
and the target sample size for the conjoint analysis phase is 800
adults. Prior to conducting the main study for both the experimental
phase and conjoint analysis phase, we will conduct at least one wave of
pretests for each study phase: one before the experimental phase and
one before the conjoint analysis phase. If the first pretest wave
reveals that changes to the measurement instruments, stimuli, or
procedures are required, a second pretest wave (for either the
experimental phase, conjoint phase, or both) will be conducted with
revised materials. The target sample size for each wave of pretests is
120 adults, split evenly between the experimental and conjoint analysis
phases.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per response \2\ Total hours
respondents respondent responses
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Experimental phase Pretest 1 Screener \3\...... 132 1 132 0.08 (5 minutes)....................... 11
Experimental Phase Pretest 1................... 66 1 66 0.33 (20 minutes)...................... 22
Conjoint Analysis Phase Pretest 1 Screener \3\. 132 1 132 0.08 (5 minutes)....................... 11
Conjoint Analysis Phase Pretest 1.............. 66 1 66 0.33 (20 minutes)...................... 22
Experimental Phase Pretest 2 Screener 3 4...... 132 1 132 0.08 (5 minutes)....................... 11
Experimental Phase Pretest 2 \4\............... 66 1 66 0.33 (20 minutes)...................... 22
Conjoint Analysis Phase Pretest 2 Screener 3 4. 132 1 132 0.08 (5 minutes)....................... 11
Conjoint Analysis Phase Pretest 2 \4\.......... 66 1 66 0.33 (20 minutes)...................... 22
Experimental Phase Screener \3\................ 2,266 1 2,266 0.08 (5 minutes)....................... 181
Experimental Phase Main Study.................. 1,133 1 1,133 0.33 (20 minutes)...................... 374
Conjoint Analysis Phase Screener \3\........... 1,760 1 1,760 0.08 (5 minutes)....................... 141
Conjoint Analysis Phase Main Study............. 880 1 880 0.33 (20 minutes)...................... 290
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Total...................................... .............. .............. 6,831 ....................................... 1,118
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
\3\ Number of screener respondents assumes a 50 percent eligibility rate with targeted recruitment.
\4\ Pretest 2 will be conducted only if changes to study materials for the respective study phase are made in response to the findings of Pretest 1 for
that phase.

As with most online and mail surveys, it is always possible that
some participants are in the process of completing the survey when the
target number is reached and that those surveys will be completed and
received before the survey is closed out. To account for this, we have
estimated approximately 10 percent overage for

[[Page 88401]]

samples in the pretest and main study of the experimental phase and
conjoint analysis phase.

II. References

The following references are on display with the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; these are not
available electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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. Harris, R.J., M.L. Trusty, J.I. Bechtold, et al. ``Memory for
Implied Versus Directly Stated Advertising Claims,'' Psychology &
Marketing, vol. 6, issue 2, pp. 87-96, 1989, <a href="https://doi.org/10.1002/mar.4220060202">https://doi.org/10.1002/mar.4220060202</a>.
2. Burke, R.R., W.S. DeSarbo, R.L. Oliver, et al. ``Deception By
Implication: An Experimental Investigation,'' Journal of Consumer
Research, vol. 14, issue 4, pp. 483-494, 1988, <a href="https://doi.org/10.1086/209130">https://doi.org/10.1086/209130</a>.
3. Louviere, J.J., T.N. Flynn, and A.A.J. Marley, Best-Worst
Scaling: Theory, Methods, and Applications. Cambridge: Cambridge
University Press, 2015.

Dated: December 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-28093 Filed 12-20-23; 8:45 am]
BILLING CODE 4164-01-P

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