Editors’ Note: This article has been updated to reflect a Correction.
On Dec. 3, 2012, the U.S. Court of Appeals for the Second Circuit held that a conviction for promoting a drug approved by the Food and Drug Administration (FDA) for an off-label use, in violation of the federal Food, Drug, and Cosmetic Act (FDCA), infringed the defendant’s First Amendment rights because the conviction rested upon the defendant’s speech.1 United States v. Caronia is important because charges similar to those levied against the defendant have led to corporate settlements worth billions of dollars. The Second Circuit’s decision is the first to determine that the FDCA’s prohibition against off-label marketing criminalizes otherwise permissible speech.
