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 representatives have “misbranded” their pharmaceutical products by promoting them for uses not approved by the FDA.
Drug Marketing to Doctors: Changes May Be On the Way
The cornerstone of many FDA enforcement actions against pharmaceuticals manufacturers in recent years has been the charge that they have "misbranded" their pharmaceutical products by promoting them for uses not approved by the FDA. Now, the Second Circuit has thrown the concept of criminal liability for misbranding by means of off-label-use promotion into turmoil.
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