Science & Research

FDA Grand Rounds

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The FDA Grand Rounds is webcast every other month to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute presentation is followed by questions from the audience.  #FDAGrandRounds.

Thursday, May 11, 2017
12:00 p.m. -1:00 p.m., Eastern Standard Time (EST) 

Presented by

Kathryn (Kit) Aikin, PhD
Senior Social Science Analyst and Research Team Lead
FDA Office of Prescription Drug Promotion
FDA Center for Drug Evaluation and Research  

Webcast Lecture 

Serious and Actionable Risks, Plus Disclosure: Investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads

 About the Presentation

Prescription drug advertising regulations require that broadcast advertisements (ads) containing product claims present the product’s major side effects and contraindications in either the audio or audio and visual parts of the ad  This is often referred to as the “major statement.”  The length of the major statement varies by product and can be quite long for certain products, especially those with a significant risk profile.

Concern exists that, as currently implemented in direct-to-consumer (DTC) ads, the major statement is often too long.  This may result in reduced consumer comprehension, minimizing important risk information and, potentially, therapeutic non-compliance due to fear of side effects.  At the same time, concern exists that DTC TV ads do not include adequate risk information or that they leave out important information.  These are conflicting viewpoints.  A possible resolution is to limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad.

This presentation discusses the results of FDA empirical research on the effectiveness of this “limited risks plus disclosure” strategy.

About the Presenter 

Dr. Kit Aikin is a Senior Social Science Analyst and Research Team Lead in FDA’s Office of Prescription Drug Promotion. Dr. Aikin’s research has focused on topics related to prescription drug promotion, including:
• consumer perceptions of direct-to-consumer advertising
• disease awareness ads
• corrective advertising
• marketing claims, and
• improvements to the consumer brief summary in direct-to-consumer print ads.

In addition to her research work, Dr. Aikin consults on regulatory policy and enforcement review of consumer and professional prescription drug promotional pieces.

A graduate of Oberlin College and Penn State University, she is a frequent speaker at academic and professional conferences and has authored more than 20 publications on topics related to prescription drug promotion. Dr. Aikin is a member of the editorial board of the Journal of Public Policy and Marketing.

 Past Grand Rounds





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