Second Circuit Finds Prohibition on Off-Label Marketing Under the FDCA Violates the First Amendment

Summary: The Second Circuit earlier this week handed down a landmark decision on the issue of free speech rights in the context of the promotion of pharmaceutical products—a decision that has the potential to significantly impact how off-label promotion cases are investigated and prosecuted by the Department of Justice in the future. In US v. Caronia, the Court, in a 2-1 decision, vacated the conviction of Alfred Caronia, a pharmaceutical sales representative found guilty of conspiring to introduce a misbranded drug into commerce in violation of the Food, Drug and Cosmetic Act (FDCA), finding that his conviction premised solely on his promotion of the drug Xyrem for off-label use violated his free speech rights under the First Amendment.