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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration Docket No. FDA2020N1307

Agency Information Collection Activities; Submission for Office of Management and Budget Review;
Comment Request; Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Notice.

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 October 13, 2021.
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 ReviewOpen for Public Comments or by using the search function. The title of this information collection is Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials. Also include the FDA
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10 a.m.12 p.m., 11601
Landsdown St., North Bethesda, MD
20852, 3017967726, PRAStaff@
fda.hhs.gov.
SUMMARY:

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

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SUPPLEMENTARY INFORMATION:

Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials OMB Control Number 0910New I. Background Section 1701a4 of the Public Health Service Act 42 U.S.C.
300ua4 authorizes FDA to conduct
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research relating to health information.
Section 1003d2C of the Federal Food, Drug, and Cosmetic Act FD&C
Act 21 U.S.C. 393d2C 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 Promotions OPDP mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. OPDPs 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 two areas:
Advertising features and target populations.
Because we recognize that the strength of data and the confidence in the robust nature of the findings is improved by utilizing 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, which can be found at:
https www.fda.gov/aboutfda/
centersoffices/officeofmedicalproducts andtobacco/cder/ucm090276.htm. The website includes links to the latest Federal Register notices and peerreviewed publications produced by our office. The website maintains information on studies we have conducted, dating back to a survey on direct-to-consumer DTC
advertisements conducted in 1999.

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The purpose of this research is to build on prior FDA research on the topic of disclosures by examining the impact of disclosures of two different types of information, detailed later in this notice. The literature on disclosures suggests their effectiveness is subject to format, design, and audience factors, among other things Ref. 1. For example, research on consumer attitudes has found some people believe that FDA evaluates certain dietary supplement claims despite the presence and consumer awareness of language required by the Dietary Supplement Health and Education Act, which clearly states that FDA has not evaluated those claims Refs. 2 and 3.
In the context of prescription drug promotion, there is initial evidence thatwhen noticeddisclosures may effectively convey important information Refs. 4 to 6; however, what role disclosures may play in educating or correcting misunderstanding warrants further investigation.
In the new study proposed here, the first type of disclosed information we will examine is clinical benefit information based on a secondary endpoint reported in a products approved labeling a secondary claim.
In some cases, truthful and nonmisleading presentations about secondary endpoints in well-designed clinical studies can provide reliable information about treatment effects that may be distinct from the treatment effects described in the products indication statement. For example, a product may be indicated to treat a specific type of cancer based on a primary endpoint of survival. However, a secondary endpoint in the study of that product may provide data about an additional distinct benefit, such as functional status.
Phase 1 of the proposed research will examine the impact of adding a disclosure about a secondary claim in DTC and healthcare provider HCPdirected promotion in the context of a prescription drug website. We will also examine the effect of the presence of a comparative claim about the secondary claim. Our proposed main outcome measures are perceptions of and attitudes toward the product, the secondary claim, and the disclosure.
The pretest and main studies for Phase 1 will have the same design, will be conducted online, and will follow the same procedure. We will examine four levels of secondary claim disclosure to explore the effects of disclosing that the secondary benefit is not one of the indicated uses of the product e.g., not a treatment for the secondary benefit
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