Free speech mandates vacating off-label promotion conviction, says Second Circuit
07 December 2012Litigation & Arbitration Alert
In a split decision raising significant questions for ongoing investigations, company practices, and future prosecutions, the United States Court of Appeals for the Second Circuit vacated a pharmaceutical sales representative’s conviction after concluding that his off-label promotion was constitutionally protected speech. The government had prosecuted the sales representative for conspiring to introduce a misbranded drug into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), and the government’s case to the jury focused on recorded conversations in which the sales representative engaged in speech about unapproved uses of an approved drug (also called off-label promotion). The appeals court held that the FDCA’s misbranding provisions do not criminalize the simple promotion of a drug for off-label use because such a construction of the statute would run afoul of the First Amendment.