FDA Issues Notice of Proposed Collection of Information

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On April 25, 2022, the United States Food and Drug Administration (FDA) published a Notice in the Federal Register, indicating its intent to perform research on “Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.”

In the Notice, FDA notes that the agency has “consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission,” specifically advertising features (including content and format), target populations, and research qualities. FDA notes that when evaluating advertising features, the agency assesses how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits. When looking at target populations, the agency can evaluate how understanding of prescription drug risks and benefits can vary as a function of audience. Focusing on research quality attempts to maximize the quality of research data through analytical methodology development and investigation of sampling and response issues.

Through this study, OPDP wants to specifically look at advertising features and target populations.

FDA is wishes to examine the 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.

The treatment preferences of both patients 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. FDA acknowledges, though, that patients might weigh the risks, benefits, or other salient characteristics of prescription drug products differently than physicians, and that there is minimal research that directly compares the treatment preferences of these two groups.

Therefore, FDA wants to understand the tradeoffs patients make among drug product characteristics – and how the tradeoffs could potentially differ from the tradeoffs made by physicians. To that end, it will split 800 patients and 800 physicians who either have or who specialize in those diseases and compare the preferences of the two groups. Participants (recruited by email through an internet panel with a screener for eligibility) will be asked to make specific choices based on fake prescription drug profiles, estimated to take 20 minutes. Individuals who work in a healthcare setting will be excluded from the patient sample, as their knowledge and experiences may not reflect those of the average consumer. Physicians who spend less than 50% of their time on direct patient care will be excluded.

Comments

FDA is specifically seeking comments on whether the proposed collection of information is necessary for the proper performance of FDA’s functions; the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information on respondents.

Comments are accepted through June 24, 2022 and can be submitted online or via mail/hand delivery/courier.

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