[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24313-24316]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-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 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: 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, [email protected]. For copies of the 
questionnaire: Office of Prescription Drug Promotion (OPDP) Research 
Team, [email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information before 
submitting the collection to OMB for approval. To comply with this 
requirement, FDA is publishing notice of the proposed collection of 
information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research. 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\
----------------------------------------------------------------------------------------------------------------
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).
                               ---------------------------------------------------------------------------------
    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 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. 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. https://doi.org/10.1016/j.sapharm.2019.01.012.
*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. https://doi.org/10.1136/bmjopen-2016-014433.
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. 
https://pubmed.ncbi.nlm.nih.gov/24470354/.
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. https://doi.org/10.1016/j.pec.2019.10.002.
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. https://doi.org/10.1093/annonc/mdt195.
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. https://doi.org/10.1016/j.jpain.2010.02.007.
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. 
https://doi.org/10.1016/j.jval.2012.08.2223.
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. https://doi.org/10.1016/j.jval.2010.11.013.
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