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MEDICAL MALPRACTICE LAW & STRATEGY

January 2013

Drug Marketing to Doctors: Changes May Be On the Way

By Janice G. Inman

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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