Court says Freedom of Speech applies to Big Pharma Sales Reps

pills and pill bottlesIn a strange decision, the United States 2nd Circuit Court of Appeals, which has jurisdiction over  ConnecticutNew York, and Vermont, ruled that a drug sales representative who promotes “off-label” uses of a particular drug is exercising their “freedom of speech.” The Court decided in a 2-1 vote, in United States v. Caronia (pdf), that the criminal conviction of Alfred Caronia, a former sales representative for a pharmaceutical company, be vacated. The case was an appeal of the sales representative’s conviction for promoting an off-label use of the drug Xyrem, which is approved for treatment of narcolepsy. The Court stated 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 also found that the FDA allows off-label use by physicians, but “prohibits the free flow of information that would inform that outcome,” while “the government’s prohibition of off-label promotion by pharmaceutical manufacturers provides only ineffective or remote support for the government’s purpose.” 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.”  It also stated “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.” Continue reading “Court says Freedom of Speech applies to Big Pharma Sales Reps”