Fasten your seatbelts.
Court: off-label promotion protected
The U.S. Court of Appeals for the Second Circuit said in a 2-1 ruling in United States v. Caronia on Monday that the "government cannot prosecute pharmaceutical manufacturers and their representatives under the [Food, Drug and Cosmetic Act (FDCA)] for speech promoting the lawful, off-label use of an FDA-approved drug." In the ruling, Judge Denny Chin wrote that so long as the off-label use of the FDA-approved drug is legal, the government's interpretation of FDCA's misbranding provisions to prohibit and criminalize the promotion of off-label use "unconstitutionally restrict[s] speech." FDCA prohibits misbranding, but does not expressly prohibit the promotion or marketing of drugs for off-label use. Chin noted that off-label promotion that is false or misleading is not protected by the First Amendment. In a dissenting opinion,
Judge Debra Ann Livingston said the ruling "calls into question the very foundations of our century-old system of drug regulation," adding that if drug companies "were allowed to promote FDA-approved drugs for nonapproved uses, they would have little incentive to seek FDA approval for those uses."
The case concerns Alfred Caronia, a former specialty sales consultant at Orphan Medical, which was acquired by Jazz Pharmaceuticals plc. He was convicted in 2008 of conspiracy to introduce a misbranded drug into interstate commerce based on audio recordings in which he promoted the off-label use of narcolepsy drug Xyrem sodium oxybate. Caronia, who was sentenced to one-year probation and 100 hours of community service, appealed, arguing that his conviction was based solely on his speech and therefore violated his First Amendment rights.
The appeals court vacated and remanded to the lower court the decision convicting Caronia.