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FDA won't appeal off-label promotion ruling

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Earlier this month, Manhattan Institute's Paul Howard, director of the Center for Medical Progress, and Jim Copland, director of the Center for Legal Policy, joined forces to author an article on the federal government's criminal prosecution of truthful speech about off-label pharmaceuticals.

The FDA announced that it won't appeal the Second Circuit's decision in U.S. v. Caronia which overturned, on First Amendment grounds, the federal prosecution of a drug company sales representative who had disseminated information about an off-label use of a drug. This may indicate that the FDA is rethinking its off-label speech regulations, which have become overly broad and unnecessarily opaque, effectively criminalizing truthful science-based speech by some parties, but not others. Well, one would hope.

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Rafael Mangual
Project Manager,
Legal Policy

Manhattan Institute


Published by the Manhattan Institute

The Manhattan Insitute's Center for Legal Policy.