After five years of often heated arguing and protracted court battles, the Washington Legal Foundation (WLF) and the Food and Drug Administration (FDA) have agreed to settle their differences regarding the FDA’s regulation of off-label drug information. Therefore, the United States Court of Appeals for the District of Columbia had no choice but to dismiss the case between the two litigants and subsequently vacate the U.S. District Court’s prior ruling that the FDA requirements are unconstitutional.

The FDA’s regulations were originally contained within a series of "Industry Guidances" published through 1995. These guidances were found by the District Court to violate a physician’s right to receive unrestricted scientific information, which is protected under the First Amendment. The court issued an injunction barring the FDA from enforcing the regulations.

The regulations were subsequently extensively revised and made part of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The FDAMA allows drug and device manufacturers to distribute materials to physicians regarding the unapproved or new use of their products, known as an off-label use, subject to certain stipulations.

The FDAMA specifically authorizes a manufacturer to "disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling of a drug or device" if it complies with several requirements: the manufacturer must submit an application for approval for the off-label use to the FDA; the manufacturer must provide the materials to the FDA prior to their distribution; the materials must be distributed in their original, unabridged form; and the materials must be clearly identified as pertaining to an unapproved use of a product.

The WLF petitioned the court to review the provisions of the FDAMA, and in 1999 the court found that they were unconstitutional. The FDA appealed and, during oral arguments, clarified its own interpretation of the provisions and its policy on enforcing them. According to the FDA, its policy is not to prevent physicians from receiving scientific information about drugs, but to ensure scientific integrity and to regulate the process by which off-label uses may be approved. With this clarification, the WLF no longer had any constitutional objection.

The Appeals Court ruling is seen as a win for all sides. Physicians can now have greater confidence in the information they receive regarding off-label uses, manufacturers can freely distribute off-label information about their drugs and devices, and the FDA can exercise greater control to make sure that the information is scientifically sound.

The ruling is also considered to be precedent setting in the area of medical communications and the First Amendment because it addresses the issue of how commercial companies may communicate with physicians regarding their products. It reaffirms the government’s position that these communications are subject to regulation and restriction.

Now that the argument appears to be settled, the FDA must establish a system by which it can review and approve off-label materials submitted by manufacturers.