A New York court ruled this week that a formerly convicted salesman’s off-label promotion is protected under his right to free speech, potentially tearing down certain of the FDA’s abilities to regulate and penalize medical device and drug marketing.
A 3-judge panel for the 2nd Circuit Court of Appeals vacated a ruling against Alfred Caronia, who was convicted in 2009 for illegally marketing narcolepsy Xyrem for uses that weren’t approved by the FDA.
In a 2-1 vote the court ruled that Caronia could not be punished for his speech. The FDA had argued that it wasn’t prosecuting Caronia’s speech, but using his speech as evidence that he had engaged in illegal marketing of Xyrem, promoting it for use in treating chronic fatigue and drowsiness, the Wall Street Journal reported.
The decision could have a ripple-effect in the FDA’s regulatory responsibilities, although the federal watchdog agency
"The First Amendment has never prohibited the government from using speech as evidence of motive or intent," dissenting Judge Debra Ann Livingston told the Journal. "The majority calls into question the very foundations of our century-old system of drug regulation."
FDA rules prohibit health products makers from marketing possible uses of medical devices or drugs until the claims have been reviewed and approved by the FDA, even in if those uses have been demonstrated in clinical trials or are approved outside the U.S.
Healthcare providers are free to use and prescribe products outside of their approved indications, but sales representatives are strictly forbidden from promoting such uses. The court seemed to take exception to that relationship, with the majority writing that the restriction "prohibits the free flow of information that would inform" a physician’s ability to use devices and drugs in an off-label manner.
"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," the court majority wrote.