In a widely anticipated ruling, the United States Court of Appeals for the Second Circuit this morning reversed the conviction of pharmaceutical sales representative Alfred Caronia for misbranding under the Federal Food, Drug, and Cosmetic Act (FDCA), based on alleged “off-label” promotion. In a 2-1 opinion, the Court concluded:

“[W]e decline to adopt the government’s construction of the FDCA’s misbranding provisions to prohibit manufacturer promotion alone as it would unconstitutionally restrict free speech. We construe the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.” Slip op. at 51.

The Court agreed with Mr. Caronia that the government’s prosecution had been based solely on speech promoting off-label uses. It found that the government’s attempt to punish such speech through the FDCA’s misbranding provisions amounted to speaker- and content-based restrictions. Thus, heightened First Amendment scrutiny would apply under Sorrell v. IMS Health, Inc., 131 S. Ct. 2653 (2011). The Court concluded that the prosecution could not survive even intermediate scrutiny under Central Hudson Gas & Electric Corp. v. Public Service Commission, 447 U.S. 557 (1980).

Sidley was co-author of an amicus brief on behalf of the defendant filed by the Medical Information Working Group.  The full ruling can be accessed at