Landmark Decision Reverses Off-Label Promotion Conviction On First Amendment Grounds

On December 3, 2012, the Second Circuit Court of Appeals issued its long-awaited opinion inUnited States v. Caronia, 703 F.3d 149 (2d Cir. Dec. 3, 2012). In this landmark decision, over a forceful dissent, a two-judge majority reversed the conviction of a former pharmaceutical sales representative for off-label promotion on First Amendment grounds. The Second Circuit declined to take on the constitutionality of the Food, Drug and Cosmetic Act's ("FDCA") mislabeling provisions because it did not interpret the Act to expressly prohibit or criminalize off-label promotion. Nevertheless, the court concluded that "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."Id. at 169.¹