Second Circuit Rules Off-Label Marketing is Protected by First Amendment

On December 3, 2012, the United States Court of Appeals for the Second Circuit, in a 2-1 opinion, vacated the criminal conviction of a pharmaceutical sales representative for promoting off-label uses of a particular drug. Rejecting the government’s theory, the court held “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDAapproved drug.”

While the opinion only binds states within the Second Circuit’s jurisdiction (New York, Connecticut, and Vermont), the decision potentially has far-reaching effects on future FDA litigation strategies and False Claims Act prosecutions.

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Topics:  FDCA, First Amendment, Off-Label Promotion, Pharmaceutical

Published In: Constitutional Law Updates, Health Updates, Science, Computers & Technology Updates

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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