On Dec. 3, 2012, the U.S. Court of Appeals for the Second Circuit issued a decision in United States v. Caronia that has the potential to turn the criminal enforcement scheme of the Federal Food, Drug and Cosmetic Act, or FDCA, on its head. A majority of the three-judge panel held that the FDCA cannot be construed to “criminalize the promotion of a drug’s off-label use” because such a construction would be at odds with First Amendment free speech rights. As the dissenting panel member noted, the Caronia ruling “calls into question the very foundations of our century-old system of drug regulation.”
Just three days later, on Dec. 6, a Ninth Circuit panel heard a similar First Amendment challenge to the wire fraud conviction of former InterMune Inc. CEO W. Scott Harkonen for allegedly false and misleading statements made in a press release regarding a clinical study for the drug Actimmune. Though Harkonen was not convicted under the FDCA (he was found not guilty of misbranding at trial), his appeal still stands to have a significant effect on determining what pharmaceutical companies and their sales representatives can and cannot say in promoting drugs.
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