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US FDA to study side-effects statement for TV ads

This article was originally published in Scrip

Executive Summary

The US FDAis moving ahead with plans to study whether inclusion of a Medwatch side-effects reporting statement in direct-to-consumer TV commercials detracts from consumer comprehension of important risk information. The study is required under the FDA Amendments Act, which mandated inclusion of a similar statement in print ads. The agency will ask 1,600 subjects to view several TV commercials, including one for a fictitious blood pressure medicine. The placement of two different side-effects reporting statements and the length of time they are presented on-screen will be tested, as will variations in their prominence. The agency said it made changes to the study design based upon feedback from its risk communication advisory panel in May. The advisors recommended studying the statement's impact on consumer understanding of risks and benefits and whether viewers can differentiate between serious adverse events and mild side-effects (Scrip Online, May 19th, 2008).

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