FDA Plans Major New Studies on DTC Advertising

Earlier this month, the FDA announced its plans to undertake three new studies relating to direct-to-consumer (DTC) advertising.  

The first, entitled "Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads," aims to test the FDA's hypothesis that consumers who view the same drug advertisement multiple times will have a slightly different view of the product each time. This hypothesis implies that if a drug company heavily advertises to consumers, it might succeed in making its products seem safer than they actually are. Comments on this study are due January 12, 2015.  

The second study, entitled “Spousal Influence on Consumer Understanding of and Response to Direct-To-Consumer Prescription Drug Advertisements,” focuses on the social contexts in which an ad is seen and how that could impact perception of a drug’s benefits or risks. Specifically, the FDA is interested in the potential for a consumer and their spouse to view an ad together and then discuss it and what impacts that may have on perceptions. Comments for this study are due January 13, 2015.  

The final study, entitled “Risk and Benefit Perception Scale Development,” will test more than 10,000 patients in an effort to examine how they assess drug risk independently of other products. The deadline for comments on this study is December 22, 2014.

While we do not yet know what the FDA plans to do with the results of these studies or how the results will impact regulatory policy, there is a clear potential that the studies could impact FDA policy concerning DTC advertisers. If you believe that ANA should weigh in on any of these studies, please let us know. Also, if you have suggestions in regard to how to respond to these FDA initiatives, that would be helpful.  

If you would like to discuss these studies with us or have any other concerns, please contact Dan Jaffe at djaffe@ana.net or 202-296-2359.