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AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA, Agency, or we) 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 November 25, 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 “Adherence Potential and Patient Preference in Prescription Drug Promotion.” 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, PRAStaff@fda.hhs.gov.
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.
Adherence Potential and Patient Preference in Prescription Drug Promotion
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 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 home page 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 study described in this notice builds on OPDP's portfolio of research on market claims and disclosures to explore the influence of statements around patient adherence and preference in prescription drug promotion. Previous FDA-funded research has shown that market claims that advertise drug characteristics unrelated to medicinal properties, such as “#1 Prescribed,” influence consumer and provider perceptions about a drug's efficacy (Ref. 1). In the same study, results of a tradeoff analysis suggested that patients prefer a drug over a competitor when this type of claim is present, and a drug without this claim required at least 1.23 percent greater efficacy to be chosen over a drug with this claim (Ref. 2). Treatment preferences may also be influenced by other drug characteristics, including its impact on quality of life, complexity of dosage regimens, administration mode, and cost to family and self (Refs. 3, 6, and 8).
It is not known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer influence perceptions of a drug. A related question is whether including a disclosure stating the uncertainty around such claims ( e.g., there is no conclusive research on whether DRUG A results in better adherence) can mitigate any misleading perceptions or influence preferences. Some evidence suggests that disclosures in prescription drug promotion are typically noticed and may help consumers and healthcare providers understand information (Refs. 2 and 4), but this topic has not been investigated in the context of adherence claims.
The present research is designed to complement previous research by experimentally examining the role of adherence and patient preference claims in prescription drug promotion.
Research questions:
1. Does the presence or absence of an implied adherence claim affect consumers' and primary care physicians' (PCPs') behavioral intentions or risk, benefit, and adherence perceptions?
2. Does the presence or absence of an adherence-related patient preference claim affect consumers' and PCPs' behavioral intentions or risk, benefit, and adherence perceptions?
3. Does the presence of both types of claims (adherence and preference) have a cumulative impact on consumers' and PCPs' behavioral intentions or risk, benefit, and adherence perceptions?
4. Does a disclosure of information to the effect that there is no conclusive research on whether the drug results in better adherence mitigate consumers' and PCPs' behavioral intentions or risk, benefit, and adherence perceptions?
To complete this research, we propose the following design for a total of 8 study conditions: 2 (patient preference claim) × 2 (adherence claim) × 2 (disclosure).
Table 1—Study Design (Implied Adherence Claim) × 2 (Patient Preference Claim) × 2 (Disclosure)
Table 2—Estimated Annual Reporting Burden