On December 3, the United States Court of Appeals for the Second Circuit overturned the 2008 conviction of Alfred Caronia, a former drug company sales representative, for violating the Food, Drug and Cosmetic Act (FDCA) by introducing a misbranded drug into interstate commerce.
In 2008, Caronia was convicted of promoting the use of Xyrem, a narcolepsy drug, to treat excessive daytime sleepiness, muscle disorders and chronic fatigue although the FDA had not approved the drug to treat those conditions.
Caronia and his attorneys maintained that it should not be a crime for drug companies and sales representatives to truthfully promote FDA-approved drugs for legal, off-label uses when doctors may engage in similar speech without penalty.
The court held 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."
An attorney for Caronia told Reuters the decision "increases the marketability of drugs, and means consumers can be fully informed by sales representatives, manufacturers and their own physicians."
Click here to read Reuters’ coverage of the decision.
Click here to read the Court’s 82-page opinion.