Judicial Ruling Apparently Allows Pharmaceutical Reps to Promote Off-Label Uses

A federal appeals court decision in United States v. Caronia could potentially allow pharmaceutical reps to promote off-label uses of drugs, according to press reports.

The 2-1 decision vacates the conviction of Alfred Caronia for "conspiracy to introduce a misbranded drug into interstate commerce." Caronia, a sales rep, promoted Xyrem (sodium oxybate) for fibromyalgia and other indications not approved by the FDA. Caronia appealed the conviction on the basis of his First Amendment rights.

A dissenting opinion notes that "the First Amendment has never prohibited the government from using speech as evidence of motive or intent" and that "the majority calls into question the very foundations of our century-old system of drug regulation."