On December 3, the US Court of Appeals for the Second Circuit vacated the criminal conviction of a pharmaceutical sales representative in United States v. Caronia.  Alfred Caronia, a sales representative for Orphan Medical, Inc, was tape-recorded by the US Food and Drug Administration promoting the drug Xyrem to physicians for unapproved uses.

On the basis of his statements describing off-label uses, Caronia was charged and convicted by a jury of conspiring to introduce a misbranded drug into interstate commerce.  Caronia appealed the conviction to the Second Circuit, arguing that the conviction violated his First Amendment rights. 

By a 2-1 decision, a panel of the Second Circuit agreed with Caronia, vacating his conviction and remanding the case to the district court.  The Second Circuit held that criminalization of truthful promotion of off-label uses violates the First Amendment, and thus construed the Food Drug and Cosmetic Act’s misbranding provisions as not prohibiting sales representatives from engaging in truthful discussions of off-label uses.  The decision did not afford First Amendment protection to misleading or false promotion of off-label uses of drugs or devices.

We are currently assessing the position the FDA and the Department of Justice are taking regarding Caronia in pending investigations and litigation matters.  We will know more in the coming weeks about the impact of the decision and the way in which the government will implement its holding.