Applying the First Amendment in a way that could significantly alter the prosecutorial and regulatory landscape in Food and Drug cases, the United States Court of Appeals for the Second Circuit has overturned the conviction of a pharmaceutical sales representative for conspiring to introduce a misbranded drug into interstate commerce, where his prosecution and conviction were based on conversations he had with physicians about off-label uses for an approved drug. In United States v. Caronia (Dkt. No. 09-5006 cr, December 3, 2012), a 2-1 decision, the Second Circuit 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.”

This is a major victory for pharmaceutical manufacturers, who have been under government scrutiny for off-label marketing practices for several years. This Kelley Drye Client Advisory analyzes the Caronia decision and discusses its implications for pharmaceutical companies.