Physican, Inform Thyself!

In United States v. Alfred Caronia, the influential United States Court of Appeals for the Second Circuit considered whether promotion, by a pharmaceutical sales representative, of a medicinal drug for medical indications not approved by the Food and Drug Administration ("FDA") could qualify as free speech protected by the First Amendment to the U.S. Constitution.  On November 30, 2011, in a jury trial in the federal court of the Eastern District of New York,

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.