Two New Developments in First Amendment Challenges to Off-Label Promotion: What's Next?

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Following the Second Circuit’s marquee First Amendment ruling in the Caronia case, two recent developments demonstrate a shift in the battleground for First Amendment challenges to the prohibition on off-label promotion under the federal Food, Drug and Cosmetic Act (FDCA). In December 2012, the U.S. Court of Appeals for the Second Circuit overturned the November 2009 conviction of Alfred Caronia for conspiracy to introduce a misbranded drug into interstate commerce, holding that Caronia’s conviction based on promotion of off-label uses of an FDAapproved drug violated the First Amendment. As we discussed in our December 20, 2012 client alert, “Second Circuit Vacates Off-Label Promotion Conviction on First Amendment Grounds in U.S. v. Caronia,” the court summarized its holding by stating “the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.”

Last week, two important developments occurred that shed new light on the potential direction of future enforcement efforts. First, Par Pharmaceutical Companies Inc. (Par) withdrew its First Amendment challenge to FDA’s off-label promotion regulatory scheme as part of a global off-label promotion settlement with the Department of Justice. This dismissal follows the settlement of a similar First Amendment challenge advanced by Allergan and litigated by our firm in 2009 and 2010. Second, the Ninth Circuit affirmed the conviction of Scott Harkonen, former Chief Executive Officer of InterMune, Inc., for wire fraud based on the dissemination of allegedly misleading information in a press release about a clinical trial. While these two developments may seem to detract from the Second Circuit’s important First Amendment ruling in Caronia, they actually point to a shift in the enforcement landscape, the heightened burden on the government in future prosecutions, and the continued role the First Amendment will play in defending such actions going forward.

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