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Comment period reopened for advertising rule
March 2012

WASHINGTON—The U.S. Food and Drug Administration (FDA) has reopened the comment period for a proposed rule that would create standards for direct-to-consumer TV and radio advertisements regarding drug side effects. The rule, proposed in 2010, would require that the main point in said advertisements be "presented in a clear, conspicuous and neutral manner." The reopened period is intended for the assessment of a document added to the docket, a "distraction study" to investigate factors that might influence viewers' understanding of risks and side effects in TV advertising. The study examined the effects of superimposed text, emotional tone of images and consistency of images with risk information. According to the FDA's findings, simultaneous audio and textual presentation of information improved understanding, but no support was found that understanding is influenced by the emotional tone of images.


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