[Federal Register Volume 88, Number 241 (Monday, December 18, 2023)]
[Notices]
[Pages 87431-87433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27652]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-0795]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; A Survey on 
Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by January 17, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The title of this 
information collection is ``A Survey on Quantitative Claims in Direct-
to-Consumer Prescription Drug Advertising.'' Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: JonnaLynn 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#b8e8eaf9ebccd9dedef8dedcd996d0d0cb96dfd7ce"><span class="__cf_email__" data-cfemail="2b7b796a785f4a4d4d6b4d4f4a05434358054c445d">[email protected]</span></a>.

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

A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug 
Advertising

OMB Control Number 0910-NEW

    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 
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.
    Direct-to-consumer (DTC) prescription drug advertising may make 
quantitative claims about the drug's efficacy or risks (Ref. 1). 
Although there is research and FDA guidance (``Presenting Quantitative 
Efficacy and Risk Information in Direct-to-Consumer Promotional 
Labeling and Advertisements,'' available at https://www.fda.gov/media/169803/download) that provides general guidelines for how to present 
quantitative information, it is not fully understood how consumers will 
interpret specific quantitative claims. We conducted a literature 
review and found that while some types of quantitative information are 
well-studied (e.g., relative frequencies), many questions remain on how 
best to communicate certain quantitative information about prescription 
drugs. For example, we do not have sufficient information about how 
consumers interpret different claims describing medians (e.g., ``People 
treated with Drug X lived for a median of 8 months'' alone or in 
combination with a definition such as ``In people receiving Drug X, 
this means that about half lived more than 8 months and about half 
lived less than 8 months'' or ``A median is the middle number in a 
group of numbers ordered from smallest to largest''). This study aims 
to survey U.S. adults about their interpretation of specific 
quantitative claims.
    We plan to use an address-based, mixed-mode methodology that will 
direct one randomly chosen member of sampled households to complete a 
20-minute online survey, with nonrespondents receiving a paper 
questionnaire. The sample will be representative of the U.S. 
population. A sample of U.S. households will be drawn from the U.S. 
Postal Service Computerized Delivery Sequence File. Adults aged 18 or 
over will be eligible for participation. Up to four contacts (mailings) 
will be sent to respondents by U.S. mail. The contacts will include the 
URL for the online survey and a unique survey login. This unique survey 
login will be used to track completed surveys without the use of 
personally identifying information. The contact method, based on recent 
recommendations (Ref. 2), includes a prenotification letter (week 1), a 
web survey invitation letter (soft launch in week 2, full launch in 
week 3), a reminder postcard sent to nonresponders (week 5), and a 
final mailing with the paper version of the survey sent to 
nonresponders (Week 7). We estimate a 40-percent response rate, based 
on recent experience with similar surveys. We estimate 1,100 
respondents will complete the main study (see table 1).
    Based on previous research (Refs. 3, 4, and 5), we plan to include 
a small prepaid incentive in the second mailing sent to the sampled 
addresses as a gesture to encourage response and maintain data quality. 
We expect that

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approximately 5 percent of the sampled addresses will be postal non-
deliverable returned letters from the first mailing (prenotification 
letter), so the second mailing is estimated to go out to the remaining 
addresses. We also will conduct an experiment to assess the efficacy of 
using a promised post-paid incentive. Seventy-five percent of the 
sample will be sent the promised incentive upon completion of the 
survey, and the remaining 25 percent of the sample will not be notified 
of or provided with any promised incentive. We opted to split the 
sample 75-25 rather than 50-50 because the initial evidence shows the 
benefits of including a promised incentive (Refs. 4, 6, and 7), and we 
aimed to maximize response rates.
    The survey contains questions about respondents' perceptions and 
understanding of several quantitative claims drawn from DTC ads in the 
marketplace. We will also measure other potentially important 
variables, such as demographics and numeracy. The survey questions will 
be informed by consumer feedback elicited in one-on-one interviews 
(approved under OMB Control No. 0910-0847). The survey is available 
upon request from <a href="/cdn-cgi/l/email-protection#a5e1f1e6f7c0d6c0c4d7c6cde5c3c1c48bcdcdd68bc2cad3"><span class="__cf_email__" data-cfemail="9edacaddccfbedfbffecfdf6def8faffb0f6f6edb0f9f1e8">[email protected]</span></a>.
    We will test whether any variables differed between modes (online 
versus mail survey) and will account for any mode effects in our 
analyses. We will examine the descriptive statistics for the survey 
items (e.g., frequencies and percentages) and explore the relationship 
between the survey items and demographic and health characteristics. We 
will weigh the data to account for different probability of selection 
and nonresponse.
    In the Federal Register of April 25, 2023 (88 FR 24997), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two submissions that were 
Paperwork Reduction Act (PRA) related. Within the submissions, FDA 
received multiple comments that the Agency has addressed in this 
notice. For brevity, some public comments are paraphrased and, 
therefore, may not state the exact language used by the commenter. All 
comments were considered even if not fully captured by our paraphrasing 
in this document. Comments and responses are numbered here for 
organizational purposes only.
    (Comment 1) One comment suggested testing claims that are addressed 
by the guidance for industry entitled ``Medical Product Communications 
That Are Consistent With the FDA-Required Labeling--Questions and 
Answers.''
    (Response 1) The focus of this study is not to test such claims. In 
addition, because these drugs are fictional, there is no label with 
which to compare the claims, which means that the guidance is not an 
applicable concept in this study. These study results could apply to 
any quantitative claims similar to those we will test.
    (Comment 2) One comment suggested recruiting a sufficient number of 
individuals with a health condition or their caregivers because they 
may be more familiar with the quantitative information in the claims 
than the general population would be.
    (Response 2) Our intent is to conduct a nationally representative 
sample to get a broad sense of how the public interprets quantitative 
claims that appear in prescription drug ads across drug classes. 
Moreover, the claims we are testing refer to several medical conditions 
(i.e., colon cancer, arthritis, seizures, migraine, lung cancer, heart 
attack or stroke, eczema), which makes it impractical to recruit a 
sufficient number of patients and caregivers for each medical 
condition. However, in response to this comment, we have added an item 
to the survey to assess whether participants have these conditions or 
have cared for someone with these conditions. This will allow us to 
explore associations between survey responses and experiences with the 
medical conditions.
    (Comment 3) One comment recommended determining participants' 
comprehension of information regarding relative risk, absolute risk, 
relative benefit, and absolute benefit.
    (Response 3) There is a body of research on many of these topics; 
see, for example, the references section in the guidance for industry 
entitled ``Presenting Quantitative Efficacy and Risk Information in 
Direct-to-Consumer (DTC) Promotional Labeling and Advertisements,'' 
available at https://www.fda.gov/media/169803/download. In this survey, 
we will examine participants' interpretations of relative benefit.
    (Comment 4) One comment requested information on the number of and 
demographic diversity of the one-on-one interviews.
    (Response 4) Since the 60-day Federal Register notice was 
published, we conducted 24 interviews (approved under OMB Control No. 
0910-0847). We recruited with demographic diversity in mind. Half (50 
percent) of the participants had some college or more education, and 
half (50 percent) had less education. Overall, 58 percent of the 
participants were women, 29 percent were non-Hispanic White, 29 percent 
were non-Hispanic Black, and 25 percent were Hispanic. We also 
recruited participants of different ages: 42 percent were between the 
ages of 18 and 39, 29 percent were between the ages of 40 and 59, and 
29 percent were 60 and older.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                   Activity                       Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Read prenotification letter..................           2,993               1           2,993  0.08 (5 min.)............................             239
Read web survey invitation letter \2\........           2,843               1           2,843  0.08 (5 min.)............................             227
Read reminder postcard.......................           2,585               1           2,585  0.03 (2 min.)............................              78
Respond to survey (web and paper)............           1,100               1           1,100  0.33 (20 min.)...........................             363
    Total....................................  ..............  ..............  ..............  .........................................             907
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The numbers assume around 5 percent postal non-deliverables from the prenotification letter and estimates nonrespondents for the subsequent
  mailings.

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://

[[Page 87433]]

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. Sullivan, H.W., K.J. Aikin, and L.B. Squiers, ``Quantitative 
Information on Oncology Prescription Drug websites,'' Journal of 
Cancer Education, vol. 33, Issue 2, pp. 371-374, 2018. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5334459)
2. Dillman, D.A., J.D. Smyth, and L.M. Christian, internet, Phone, 
Mail, and Mixed-Mode Surveys: The Tailored Design Method, 4th ed., 
John Wiley & Sons, Inc.: Hoboken, NJ, 2014.
*3. Cheung, Y.T.D., X. Weng, M.P. Wang, et al., ``Effect of Prepaid 
and Promised Financial Incentive on Follow-Up Survey Response in 
Cigarette Smokers: A Randomized Controlled Trial,'' BMC Medical 
Research Methodology, vol. 19, Article 138, 2019. (https://link.springer.com/article/10.1186/s12874-019-0786-9)
4. Mercer, A., A. Caporaso, D. Cantor, et al., ``How Much Gets You 
How Much? Monetary Incentives and Response Rates in Household 
Surveys,'' Public Opinion Quarterly, vol. 79, pp. 105-129, 2015.
5. Sun, H., J. Newsome, J. McNulty, et al., ``What Works, What 
Doesn't? Three Studies Designed to Improve Survey Response,'' Field 
Methods, vol. 32, Issue 3, pp. 235-252, 2020. (https://doi.org/10.1177/1525822X20915464)
6. Ellis, J., J. Charbonnier, C. Lowenstein, et al., ``Assessing the 
Impacts of Different Incentives and Use of Postal Mail on Response 
Rates,'' American Association for Public Opinion Research (AAPOR) 
Conference, Chicago, IL, 2022, May.
*7. Yu, S., H.E. Alper, A.M. Nguyen, et al., ``The Effectiveness of 
a Monetary Incentive Offer on Survey Response Rates and Response 
Completeness in a Longitudinal Study,'' BMC Medical Research 
Methodology, vol. 17, Article 77, 2017. (https://bmcmedresmethodol.biomedcentral.com/articles/10.1186/s12874-017-0353-1)

    Dated: December 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27652 Filed 12-15-23; 8:45 am]
BILLING CODE 4164-01-P


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