On December 3, 2012, the United States Court of Appeals for the Second Circuit handed down its decision in U.S. v. Caronia, and ruled that the government cannot prosecute pharmaceutical manufacturers for speech promoting the lawful, off-label use of an FDA-approved drug. Coincidently, the Food and Drug Administration (FDA) has not issued any Warning or Untitled Letters since the Caronia decision. In 2012, the FDA issued twenty-eight enforcement letters. The most recent was an Untitled Letter dated November 27, 2012, to Salix Pharmaceuticals, Inc. and Napo Pharmaceuticals, Inc. regarding its website and podcast for the investigational new drug, Crofelemer.
Although the Caronia decision only applies in three states, the FDA may have to change its approach regarding off-label marketing concerns. In the past, it was enough for the FDA to allege in its letters that false or misleading speech was used to market drugs off-label. Will the FDA now have to prove off-label marketing and make it clear that promotional statements were offered as evidence of intended use?
The Wall Street Journal reported on January 23, 2013, that according to FDA officials, the government will not appeal the Caronia decision, and the FDA "does not believe that the Caronia decision will significantly affect the agency's enforcement of the drug misbranding provisions of the Food, Drug, and Cosmetic Act." In the meantime, should we expect FDA to issue guidance regarding off-label speech, issue new off-label speech regulations, or continue with business as usual? The next Warning or Untitled Letter from FDA may provide some guidance as to FDA’s position with regard to off-label speech.