FDA wants feedback on DTC quantitative claims survey

The US Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) announced plans to conduct a study gauging respondents’ perception and understanding of quantitative claims drawn from direct-to-consumer advertisements.

FDA said it conducted a literature review and found that while some types of quantitative information are well-studied, “many questions remain on how best to communicate certain quantitative information about prescription drugs.”

For example, FDA said it lacks information about how consumers interpret certain median claims, such as “People treated with Drug X lived for a median of 8 months” or “In people receiving Drug X, this means that about half lived more than 8 months and about half lived less than 8 months.” The study aims to survey adults about their interpretation of these quantitative claims.

The agency estimates a 40% response rate, with 1,100 respondents completing the main survey. It plans to use an address-based methodology that will target one member of a randomly chosen household to complete a 20-minute online survey, with nonrespondents receiving a paper questionnaire. The sample will be representative of the US population.

The proposed survey was announced in a Federal Register notice on Monday. The notice was published under the Paperwork Reduction Act of 1995 (PRA), which requires federal agencies to submit to the OMB each proposed collection of information and to allow 60 days for public comment.

In the notice, FDA invites comments on whether the proposed collection of information will have practical utility, the accuracy of FDA’s estimate of the burden of the proposed collection of information, ways to minimize the burden of the collection of information on respondents, and methods to enhance the quality, utility, and clarity of the information to be collected.

OPDP’s mission is 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.” Its research focuses on three topic areas: advertising features, including content and format; target populations; and research quality. This study will inform the first topic area, advertising features.

The public has 60 days to comment.

Federal Register notice

FDA wants feedback on DTC quantitative claims survey

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