FDA loses another battle in off-label information suit

Federal judge includes FDAMA in decision

The Food and Drug Administration has lost another battle in its ongoing fight over the dissemination of information on off-label indications of medical products. A year after his first ruling, and after numerous appeals, federal district court judge Royce Lamberth made a final decision July 29 about the FDA’s off-label policies, calling them unconstitutional. The ruling brings to a close, at least on the district court level, a suit brought against the FDA in 1994 by the Washington Legal Foundation (WLF), which claimed that the FDA’s off-label information dissemination policies infringed on manufacturers’ First Amendment rights (SCAN 4/28/99).

Lamberth made his original decision in July 1998. Four months later, Congress’s FDA Modernization Act (FDAMA) was implemented, including what the FDA considered relaxed guidelines for the distribution of off-label data. The FDA requested that Lamberth clarify his July 1998 injunction to apply only to pre-FDAMA guidelines.

But this past February, the judge denied the request, stating that his ruling applied to the agency’s policies, rather than specific guidance documents, and therefore included the FDAMA. Lamberth requested supplemental briefs from the FDA and WLF that would specifically address the FDAMA and its implementing regulations, and based on those briefings, ruled that in fact the FDAMA perpetuates the policies he held unconstitutional in his decision a year earlier.

The case has been particularly interesting to such advocacy organizations as the American Association of Advertising Agencies (AAAA) of Washington, DC, which perceives it as a challenge to the FDA’s marketing policies.

“This is a judicial attack on the notion that the FDA has the final say (on marketing matters),” said John Kamp, senior vice president of AAAA. “The court has told the FDA that it cannot be the ultimate arbiter of truth in this area. (The decision) changes everything at the FDA relative to marketing.”

The Health Industry Manufacturers Association (HIMA) views Lamberth’s decision as significant since it opens up off-label data dissemination in a new way, according to Marlene Tandy, associate general counsel for HIMA. But the issue still isn’t completely resolved, Tandy warns.

“The door may not be open forever,” Tandy said. “The FDA has to decide whether to appeal the case to a higher court, and if they appeal, there’s a chance that down the road a higher court could take a different view (than Judge Lamberth).”

The FDA has 60 days to file an appeal with the U.S. Court of Appeals for the Washington, DC, circuit. Simultaneously, the agency may also ask Lamberth to stay his decision during the time that the appeal is pending. But to receive a stay from Judge Lamberth, the FDA would have to demonstrate that there will be irreparable harm to public health if the decision is allowed to stand, according to Richard Famt, chief counsel at the WLF.

“In this case, (making that argument) would be particularly hard, because ever since Lamberth’s July 1998 decision, manufacturers have been disseminating off-label information, and the world hasn’t fallen apart,” Famt said.

How companies proceed under the judge’s ruling depends on their own judgment, Tandy said. Some companies may choose to avoid the whole off-label data dissemination issue until it becomes clear whether the FDA will appeal and what the outcome of that motion will be—a wait that could take years. Others may choose—or have already chosen—to go ahead and distribute off-label data. If the FDA requests and receives a stay on the decision, how companies should distribute off-label data could once again become confusing, as the FDA decides how to hold them accountable to some form of a guidance. If a stay is not granted, and the ruling stands, the FDA may move to establish an interim guidance that takes Lamberth’s judgment into account, Tandy said.