Caronia was found guilty of conspiracy to introduce a misbranded drug into interstate commerce, a misdemeanor violation of 21 U.S.C. §§ 331(a) and 333(a)(1). Specifically, Caronia, a pharmaceutical sales representative, promoted the drug Xyrem [a potent depressant of the central nervous system] for "off-label use," that is, for a purpose not approved by the [FDA].Two of three judges on a panel of the Second Circuit disagreed, vacating Caronia' conviction, and remanding the case to the district court. On December 3, 2012, the majority
conclude[d] simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA [Food, Drug, and Cosmetics Act] for speech promoting the lawful, off-label use of an FDA-approved drug.This important decision appears to augment physicians' right to prescribe drugs to patients for off-label uses by further allowing physicians access to truthful information from pharmaceutical companies about known off-label uses of those drugs.
A judicial decision of such significance to physicians, patients, and pharmaceutical companies may attract the attention of the U.S. Supreme Court. In the meantime, a wider horizon beckons for off-label uses of medicines.