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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