160 Common U.S. Food and Drug Administration (“FDA”) approved drugs which are used for “off label” purposes represent approximately 21 percent of all prescriptions in the United states. Physicians may prescribe FDA approved drugs for any therapeutic use that is appropriate in their medical judgment. The FDA, however, prohibits pharmaceutical companies and their employees from promoting the use of FDA approved drugs for “off label” use. Although there is no express prohibition in the Food Drug and Cosmetic Act or its regulations prohibiting the promotion of drugs for off label use, the government uses a criminal statute which prohibits the introduction of “misbranded” drugs into interstate commerce ( 21 U.S.C. 331(a) and 333(a)(1) to prosecute pharmaceutical companies, their employees and sometimes physicians who are “promoting” the off-label use of drugs.
On December 3, 2012, a panel of the U.S. 2nd Circuit Court of Appeals in New York, by a 2 to 1 vote overturned the conviction of a drug salesman for the promotion of the off label use of Xyrem. In the case, U.S. v. Caronia, the Court held that Mr. Caronia was being prosecuted both for the content of his speech and because of the identity of the speaker.
The government argued that Mr. Caronia was not being prosecuted for his speech, but for “mislabeling” and that the speech was being introduced only to show intent. The Court rejected the government’s position noting that the whole focus of the prosecution was on his speech rather than mislabeling.
The Court noting the content and speaker based restrictions required “heightened scrutiny” under constitutional law. It found that potentially bad decisions by doctors cannot justify content based burdens. It noted the essential contradiction of the government’s position.
The government’s construction of the FDCA essentially legalizes the outcome --off label use -- but prohibits the free flow of information that would inform the outcome.
The Court noted that there were many less restrictive methods of meeting legitimate government concerns like prosecution and warnings related to misrepresentation or misinformation related to the off label use and the medical malpractice tort system to provide liability for the inappropriate off label use.