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US FDA to study visual distractions in DTC TV ads

This article was originally published in Scrip

Executive Summary

A US FDAstudy on visual distractions in direct-to-consumer television commercials will aid the agency in interpreting the FDA Amendments Act's requirement that the major statement of risks be presented in a "clear, conspicuous and neutral" manner. Under FDAAA, the agency must develop regulations by March 2010 on standards for determining whether side-effect and contraindication information is presented in this manner. The study is also aimed at evaluating whether use of competing, compelling visuals about a drug's benefits interfere with viewers' processing and comprehension of risk information, and whether compelling visuals affect the way consumers think about a branded product. The agency has revised its initial plans for the study, first announced in August 2007, from a mall-intercept to an internet-administered procedure, and has doubled the sample size to 2,400 respondents, who will view commercials for a fictitious blood pressure medicine.

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