The cornerstone of many U.S. Food and Drug Administration (FDA) enforcement actions against pharmaceuticals manufacturers in recent years has been the charge that they and their represetatives have “misbranded” their pharmaceutical products by promoting them for uses not approved by the FDA.
Drug Misbranding Redefined
The U.S. Court of Appeals for the Second Circuit has thrown the concept of criminal liability for misbranding by means of off-label-use promotion into turmoil in <i>United States v. Caronia.</i>
By
Janice G. InmanThis premium content is locked for Business Crimes Bulletin subscribers only
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