Four Ways FDA’s New Intended Use Regulations Affect Drug and Medical Device Companies

Nov 08, 2021

Posted by Sidley Austin

Drug and medical device manufacturers may have increased potential exposure in off-label promotion cases under the recent final rule from the U.S. Food and Drug Administration (FDA) amending its regulatory definition of “intended use.”1 The rule went into effect on September 1. “Intended use” determines whether a drug or medical device is misbranded or otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).2 The new final rule purports to broaden the definition of intended use significantly to include any evidence the FDA regards as “relevant.” It also brings within the scope of the regulation many traditional manufacturer activities undertaken in reliance on established “safe harbor” policies permitting the dissemination of information about off-label uses. Manufacturers should revisit their reliance on the safe-harbored status of particular activities in view of the final rule. Continue reading 

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