FDA Grand Rounds
The May 11 FDA Grand Rounds webcast: What FDA social science research tells us about risk info in prescription drug ads...
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FDA Research: an Alternative Approach to Presenting Risk Information in Prescription Drug TV Ads
Thursday, May 11, 2017
12:00 p.m. -1:00 p.m. EST
Kathryn (Kit) Aikin, PhD
Senior Social Science Analyst
FDA Office of Prescription Drug Promotion
FDA Social Scientist's research tells you 4 things you need to know:
1. How social science research informs approaches regulatory problems.
2. What the "major statement" is in direct-to-consumer TV ads.
3. What the impact is of the "limited risks plus disclosure strategy" on consumer perceptions of product risks and benefits.
4. How the "limited risks plus disclosure strategy" may contribute to regulatory strategy around communication of important information about prescription drugs.
About the Presentation
Prescription drug ad regulations require that broadcast ads containing product claims give the product’s major side effects and contraindications in either the ad's audio or audio and visual sections. This is often referred to as the “major statement.” The length of the major statement can be quite long for certain products, resulting in potentially, therapeutic non-compliance among other things. Dr. Aikin presents FDA empirical research on the effectiveness of a “limited risks plus disclosure” strategy--limiting the risks in the major statement to those that are serious and actionable, and including a disclosure to alert consumers of other product risks not included in the ad.
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