FDA Funded Research Shows claim #1 Prescribed Has Value with Consumers

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According to research funded by the FDA and published last month, participants in a study on direct-to-consumer (DTC) advertising were more likely to select a product with a claim of “#1 Prescribed.”


According to the study, the research examined the tradeoff of market claim and efficacy information in DTC print advertising for prescription drugs. Two hundred fifteen adult participants with a self-reported diagnosis of diabetes were recruited through an online consumer panel. Participants were presented a series of choices. Each choice pair represented a prescription diabetic nerve pain drug with a different efficacy level and one of the two had a market claim of “#1 Prescribed”. Participants indicated which drug they would prefer if they had to choose one.


Results showed an advantage of #1 Prescribed. A drug without this claim needed at least 1.23% greater efficacy to be chosen over a drug with this claim.

As reported in Regulatory Affairs, first author Kathryn Aikin and second author Kevin Betts, both of FDA’s Office of Prescription Drug Promotion, and two co-authors noted, “The extrinsic cue of #1 Prescribed slightly influenced participants’ choice, even when the intrinsic cue of efficacy information was available”.


The study comes as last October, FDA offered draft guidance on how to present efficacy and risk information in DTC promotional labeling and advertising. In its guidance, FDA recommends that firms display quantitative efficacy or risk information in numeric formats (“e.g., absolute frequencies or percentages; whole numbers; denominators with a base of 10”) and with appropriate context (“e.g., adding absolute frequency presentations to relative frequency presentations”); provide formatting considerations for illustrating quantitative efficacy or risk information in a visual aid; and include quantitative efficacy or risk information about the control group when it is provided for the treatment group in the ads.


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