Notice2022-08728
Agency Information Collection Activities; Proposed Collection; Comment Request; Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion
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Published
April 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 research entitled "Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion."
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<title>Federal Register, Volume 87 Issue 79 (Monday, April 25, 2022)</title>
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[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24313-24316]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08728]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-0081]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Tradeoff Analysis of Prescription Drug Product Claims
in Direct-to-Consumer and Healthcare Provider Promotion
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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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 research entitled ``Tradeoff Analysis of
Prescription Drug Product Claims in Direct-to-Consumer and Healthcare
Provider Promotion.''
DATES: Submit either electronic or written comments on the collection
of information by June 24, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 24, 2022. 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 June 24, 2022. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<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 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-2022-N-0081 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Tradeoff Analysis of Prescription
Drug Product
[[Page 24314]]
Claims in Direct-to-Consumer and Healthcare Provider 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: Regarding the information collection:
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#67373526341306010127010306490f0f1449000811"><span class="__cf_email__" data-cfemail="27777566745346414167414346094f4f5409404851">[email protected]</span></a>. For copies of the
questionnaire: Office of Prescription Drug Promotion (OPDP) Research
Team, <a href="/cdn-cgi/l/email-protection#93d7c7d0e1f6e0f6f2e1f0fbd3f5f7f2bdfbfbe0bdf4fce5"><span class="__cf_email__" data-cfemail="1f5b4b5c6d7a6c7a7e6d7c775f797b7e3177776c31787069">[email 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.
Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-
Consumer and Healthcare Provider 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 product characteristics impact the
communication and understanding of prescription drug risks and
benefits. Focusing on target populations allows us to evaluate how
understanding of prescription drug risks and benefits may vary as a
function of audience, and our focus on research quality aims at
maximizing the quality of research data through analytical methodology
development and investigation of sampling and response issues. This
study will inform the first and second topic areas, advertising
features and target populations.
Because we recognize that the strength of data and the confidence
in the robust nature of the findings are improved by using 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,
which can be found 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>. The website includes links to the latest Federal Register
notices and peer-reviewed publications produced by our office.
The proposed research examines the relative importance of
prescription drug product information such as prescription drug
efficacy, risk, adherence, and patient preference claims in two medical
conditions (type 2 diabetes and psoriasis) in consumer and physician
samples. When confronted with an important decision, people tend to
make choices that reflect a series of tradeoffs between certain
desirable and undesirable attributes of a product, service, or
experience. Pharmaceutical manufacturers provide information about
prescription drug products, including side effects, contraindications,
and effectiveness through product labeling and promotional materials
(21 CFR 202.1(e)).
[[Page 24315]]
The treatment preferences of diagnosed consumers and treating
physicians have been shown to be influenced by certain characteristics,
such as the perceived drug's impact on quality of life, complexity of
dosage regimens, mode of administration, cost to family and self, and
marketing claims unrelated to medicinal properties (Refs. 1 to 5).
Although diagnosed consumers may weigh the risks, benefits, or other
salient characteristics of prescription drug products differently than
physicians, little research directly compares the treatment preferences
of these two groups (Ref. 6). Understanding the tradeoffs among drug
product characteristics diagnosed consumers make--and how the tradeoffs
could potentially differ from the tradeoffs made by physicians--will
provide valuable insight into the relevance and impact of various
product attributes and promotional claims on informed choices and
treatment decisions.
We intend to examine these tradeoffs using a choice-based conjoint
analysis, also known as a discrete choice experiment. Conjoint analysis
is a broad class of survey-based techniques used to estimate how
attractive or influential different features of choice options or
product attributes are in determining purchase behavior or treatment
choices (Ref. 7). Conjoint analysis can be used to examine the joint
effects and tradeoffs of multiple variables or product attributes on
decisions. A choice-based conjoint analysis is based on the principle
that products are composed of a set of attributes, and each attribute
can be described using a finite number of levels. In the proposed
research, participants will be shown a carefully designed sequence of
choice tasks containing up to five hypothetical product attributes--in
this case, profiles describing fictitious prescription drug products
for either type 2 diabetes or psoriasis. Using data from the choices
that participants make across these tasks, we can use statistical
techniques to draw inferences about the relative value they place on
different product attributes, estimate the relative importance of
different attributes, explore the tradeoffs that consumers and
physicians are willing to make to avoid or accept specific attribute
levels, and compare the preferences of these two groups (Ref. 8).
We estimate that participation in the study will take approximately
20 minutes. Adult 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. The
consumer sample will consist of adults who self-report as having been
diagnosed by a healthcare provider with either psoriasis or type 2
diabetes. For the consumer sample, we will exclude individuals who work
in healthcare settings because their knowledge and experiences may not
reflect those of the average consumer. The physician sample will
consist of primary care physicians and specialists who report treating
patients with psoriasis or type 2 diabetes. For the physician sample,
we will exclude individuals who spend less than 50 percent of their
time on direct patient care. Department of Health and Human Services
employees and individuals who work in the marketing, advertising, or
pharmaceutical industries will be excluded from both respondent groups.
Respondents will receive a survey invitation with a unique password
protected link. All panel members are recruited following a double opt-
in process. Sample sizes were estimated by combining approaches for
conjoint analysis suggested by Orme (Ref. 9) and Johnson et al. (Ref.
10).
The target sample size for the main study is 800 physicians and 800
consumers, with half of each cohort focusing on treatments for
psoriasis and the other half focusing on treatments for type 2
diabetes. Prior to conducting the main study, we will conduct at least
one pretest. If the first pretest reveals that changes to the
measurement instruments, stimuli, or procedures are required, a second
pretest will be conducted with revised materials. The target sample
size for each wave of pretests is 60 physicians and 60 consumers.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average burden
Activity Number of responses per Total annual per response Total hours
respondents respondent \2\ responses \3\
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Pretest 1 Screener, Physicians 95 1 95 0.08 (5 minutes) 8
\4\.
Pretest 1 Screener, Consumers 95 1 95 0.08 (5 minutes) 8
\4\.
Physician Pretest 1........... 66 1 66 0.33 (20 22
minutes).
Consumer Pretest 1............ 66 1 66 0.33 (20 22
minutes).
Pretest 2 Screener, Physicians 95 1 95 0.08 (5 minutes) 8
4 5.
Pretest 2 Screener, Consumers 95 1 95 0.08 (5 minutes) 8
4 5.
Physician Pretest 2 \4\....... 66 1 66 0.33 (20 22
minutes).
Consumer Pretest 2 \4\........ 66 1 66 0.33 (20 22
minutes).
Physician Main Study Screener 1,258 1 1,258 0.08 (5 minutes) 101
\4\.
Physician Main Study.......... 880 1 880 0.33 (20 290
minutes).
Consumer Main Study Screener 1,258 1 1,258 0.08 (5 minutes) 101
\4\.
Consumer Main Study........... 880 1 880 0.33 (20 290
minutes).
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Total..................... .............. .............. 4,920 ................ 902
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ 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
both samples in the study.
\3\ Burden estimates of less than 1 hour are expressed as a fraction of an hour in decimal format.
\4\ Number of screener respondents assumes a 70 percent eligibility rate with targeted recruitment.
\5\ Pretest 2 will be conducted only if changes to study materials are made in response to the findings of
Pretest 1.
[[Page 24316]]
II. 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.
1. Aikin, K.J., K.R. Betts, K.S. Ziemer, et al. (2019). ``Consumer
Tradeoff of Advertising Claim Versus Efficacy Information in Direct-
to-Consumer Prescription Drug Ads.'' Research in Social and
Administrative Pharmacy, 15(12), 1484-1488. <a href="https://doi.org/10.1016/j.sapharm.2019.01.012">https://doi.org/10.1016/j.sapharm.2019.01.012</a>.
*2. Arroyo, R., A.P. Sempere, E. Ruiz-Beato, et al. (2017).
``Conjoint Analysis to Understand Preferences of Patients With
Multiple Sclerosis for Disease-Modifying Therapy Attributes in
Spain: A Cross-Sectional Observational Study.'' BMJ Open, 7(3),
e014433. <a href="https://doi.org/10.1136/bmjopen-2016-014433">https://doi.org/10.1136/bmjopen-2016-014433</a>.
3. Fraenkel, L., L. Suter, C.E. Cunningham, et al, (2014).
``Understanding Preferences for Disease-Modifying Drugs in
Osteoarthritis.'' Arthritis Care & Research, 66(8), 1186-1192.
<a href="https://pubmed.ncbi.nlm.nih.gov/24470354/">https://pubmed.ncbi.nlm.nih.gov/24470354/</a>.
4. Katz, D.A., C. Hamlin, M.W. Vander Weg, et al. (2020).
``Veterans' Preferences for Tobacco Treatment in Primary Care: A
Discrete Choice Experiment.'' Patient Education and Counseling,
103(3), 652-660. <a href="https://doi.org/10.1016/j.pec.2019.10.002">https://doi.org/10.1016/j.pec.2019.10.002</a>.
5. Wouters, H., G.A. Maatman, L. Van Dijk, et al. (2013). ``Trade-
Off Preferences Regarding Adjuvant Endocrine Therapy Among Women
With Estrogen Receptor-Positive Breast Cancer.'' Annals of Oncology,
24(9), 2324-2329. <a href="https://doi.org/10.1093/annonc/mdt195">https://doi.org/10.1093/annonc/mdt195</a>.
6. Gregorian, Jr., R.S., A. Gasik, W.J. Kwong, et al. (2010).
``Importance of Side Effects in Opioid Treatment: A Trade-Off
Analysis With Patients and Physicians.'' The Journal of Pain,
11(11), 1095-1108. <a href="https://doi.org/10.1016/j.jpain.2010.02.007">https://doi.org/10.1016/j.jpain.2010.02.007</a>.
7. Johnson, FR, E. Lancsar, D. Marshall, et al. (2013).
``Constructing Experimental Designs for Discrete-Choice Experiments:
Report of the ISPOR Conjoint Analysis Experimental Design Good
Research Practices Task Force.'' Value in Health, 16(1), 3-13.
<a href="https://doi.org/10.1016/j.jval.2012.08.2223">https://doi.org/10.1016/j.jval.2012.08.2223</a>.
8. Bridges, J.F.P., A.B. Hauber, D. Marshall, et al. (2011).
``Conjoint Analysis Applications in Health--A Checklist: A Report of
the ISPOR Good Research Practices for Conjoint Analysis Task
Force.'' Value in Health, 14(4), 403-413. <a href="https://doi.org/10.1016/j.jval.2010.11.013">https://doi.org/10.1016/j.jval.2010.11.013</a>.
9. Orme, B. (2019). Getting Started With Conjoint Analysis:
Strategies for Product Design and Pricing Research (Fourth ed.).
Madison, WI: Research Publishers LLC.
10. Johnson, F., B. Kanninen, M. Bingham, et al. (2006).
``Experimental Design for Stated-Choice Studies.'' In: Valuing
Environmental Amenities Using Stated Choice Studies (pp. 159-202).
B.J. Kanninen (Ed.). Dordrecht: Springer.
Dated: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08728 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P
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