Publishing in today's Federal Register, FDA has announced a planned study on the use of composite endpoint scores in prescription drug DTC advertising (see
https://federalregister.gov/a/2012-20783). The notice states that the purpose of the research is as follows: "Given the lack of research on consumer understanding of composite scores and how to best present this information in DTC advertisements, the main goal of the current research is to evaluate how consumers interpret and respond to DTC prescription drug advertising that includes benefit information based on composite scores." The study will examine the presentation of composite endpoint benefit information with/without "educational intervention" to help consumers comprehend the basis of the composite benefit claim and will also examine whether composite benefit claims influence consumers' perceptions of a drug's safety and effectiveness. Companies utilizing composite endpoint claims in DTC advertising should be aware that this is an area FDA may be giving more scrutiny to in the future. FDA is receiving comments from stakeholders on this proposed study for the next 60 days (with comments due by October 22, 2012).
Julie Tibbets is a partner in the Food, Drug & Device/FDA practice of Alston & Bird LLP. She regularly advises companies on their advertising and promotional materials and can be contacted at (202) 239-3444 or at julie.tibbets@alston.com.