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FDA Loses Landmark Off-Label Promotion Decision

The United States Food and Drug Administration (U.S. FDA) prosecuted criminally Alfred Caronia, a former pharmaceutical sales representative for Orphan Medical, Inc., in United States v. Caronia, for promoting usage of drugs for other than the labeled use, even though “off-label” use is permitted if so prescribed by physicians.

On November 30, 2009, the jury found Caronia guilty of conspiracy to introduce a misbranded drug into interstate commerce. Caronia appealed the decision. The Second Circuit Court of Appeals vacated the convictions, holding that FDA’s prosecution of these promotional activities violated the First Amendment’s protection of the right of freedom of speech. The court drew a distinction between FDA viewing promotional activities as an aspect of determining intended use (which FDA may do) and the FDA banning promotion of lawful drug uses even if off-label (which the First Amendment forbids FDA from doing). The Court clearly stated that the First Amendment forbids FDA from banning promotion of drugs for their lawful intended use.

The decision is important for drug manufacturers. It confirms that drug manufacturers may rely on the protections of the first amendment in promotional activities, provided they promote lawful conduct. In other words, by following FDA’s “intended use” policies, drug companies may safely claim that their drugs can diagnose, mitigate, treat, cure, or prevent diseases for which they are intended. The First Amendment’s protection of commercial speech may extend to protect drug company representatives who promote lawful but “off-label” uses for their products.

The decision, United States v. Caronia, was issued nearly two years to the day from when it was argued, an unusually lengthy wait for a decision. Typically, a decision is made within 60 days.

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