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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