Second Circuit Holds First Amendment Bars Conviction Based Solely on Off-Label Promotion of FDA-Approved Drug


In its long-awaited decision in United States v. Caronia, the Second Circuit ruled today that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug. By a vote of two-to-one, the panel vacated the conviction of a pharmaceutical sales representative for conspiracy to introduce a misbranded drug into interstate commerce in violation of the Food, Drug, and Cosmetic Act (“FDCA”). The Second Circuit recognized that criminalizing a drug manufacturer’s speech about a drug’s lawful, off-label use would violate the First Amendment; the court therefore construed the FDCA not to prohibit such speech. The majority did not decide whether, or to what extent, the First Amendment would allow the government to rely upon a pharmaceutical manufacturer’s promotional statements regarding off-label uses as evidence of the drug’s “intended use” in a prosecution for introducing a drug into commerce without “adequate instructions for use.” The majority’s analysis calls into serious doubt, however, the government’s ability to prosecute a misbranding charge based on off-label promotion or, more broadly, to rely upon a drug manufacturer’s dissemination of truthful, non-misleading information about a drug’s off-label uses in such a prosecution.

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