OPDP to Study Product Claims in DTC and HCP Promotions

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Earlier this year, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) published a notice in the Federal Register about a study it expects to conduct regarding product claims in direct-to-consumer (DTC) and healthcare provider (HCP) promotion.

The proposed research will examine the importance of prescription drug product information, including its efficacy, risk, adherence, and patient preference claims in two medical conditions (type 2 diabetes and psoriasis), in consumer and physician samples. FDA noted that “pharmaceutical manufacturers provide information about prescription drug products, including side effects, contraindications, and effectiveness through product labeling and promotional materials” to both consumers and healthcare providers.

FDA further noted that 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.” Further, while one might expect consumers to weigh the risks, benefits, or other salient characteristics of prescription drug products differently than physicians, there is little research that actually compares the treatment preferences of the two groups.

FDA expects to examine the tradeoffs using a choice-based conjoint analysis, where 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.” The consumer sample will include adults who self-report as being diagnosed with either psoriasis or type 2 diabetes and will exclude those who work in healthcare settings. The physician sample will include primary care physicians and certain specialists who work with patients with either psoriasis or type 2 diabetes, with those who spend less than 50% of their time on direct patient care excluded.

Then, using the data gathered from the choices participants choose, FDA 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.

FDA is seeking specific comments in response to the Notice, including:

(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

(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 technology.

Comments should be submitted no later than June 24, 2022.

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