In The FDA Crosshairs: Composite Scores In Drug Ads

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Originally published in Law360, New York on October 19, 2012.

On Aug. 23, 2012, the U.S. Food and Drug Administration published a notice announcing proposed research titled “Communicating Composite Scores in Direct-to-Consumer (DTC) Advertising,” designed to study and collect information regarding how consumers understand and interpret composite endpoint scores in DTC advertising.

By way of background, the efficacy of a pharmaceutical company’s drug is often measured by multiple endpoints, that is, multiple individual symptoms, which may be combined to form an overall score also known as a “composite score.” A pharmaceutical company may market a drug for the relief of a particular symptom when the drug has a significantly better composite score than the placebo.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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