On December 3, 2012, the United States Court of Appeals for the Second Circuit (which is based in New York City) issued a long-awaited ruling in United States v. Caronia, a case involving off-label promotion. In a 2-1 82-page decision that involves a vigorous dissent, the Court vacated the criminal conviction of Alfred Caronia, a former sales representative for a pharmaceutical company. The sales representative was convicted for promoting the drug Xyrem for a use that had not been approved by FDA.
The Court ruled that “we construe the FDCA as not criminalizing the simple promotion of a drug’s off-label use because such a construction would raise First Amendment concerns.” The Court concluded that the record demonstrated that the government had prosecuted Mr. Caronia for “mere off-label promotion.” Slip Op. at 26.
The Court explained that FDA’s construction of the FDCA legalizes the outcome of off-label use by doctors, but “prohibits the free flow of information that would inform that outcome.” The Second Circuit concluded that “the government’s prohibition of off-label promotion by pharmaceutical manufacturers ‘provides only ineffective or remote support for the government’s purpose.’” Slip Op. at 47.
The Court also ruled that it construes “the misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved prescription drugs.” In addition the Court ruled “that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful, off-label use of an FDA-approved drug.” Slip. Op. at 51.
It goes without saying that this is a very significant ruling that will have wide implications for FDA and the companies and individuals regulated by FDA. Our firm will provide a more detailed analysis of the ruling in the upcoming days. Our previous post on the case is available here.