U.S. companies in legal limbo over FDA off-label protocols

Confusion over Modernization Act continues

Medical device and drug companies are still in the dark about the U.S. government’s policy on the distribution of off-label information about medical products. Food and Drug Administration guidelines designed to clarify the situation are mired in legal battles, and due to the confusion only a handful of companies have taken advantage of the FDA’s relaxed rules on off-label promotion.

Under long-time FDA policy, physicians could prescribe drugs or use devices for off-label indications, but companies were prohibited from marketing their products for applications not included in the FDA’s original clearance. That changed in 1997 with the passage of the FDA Modernization Act, which ordered the FDA to develop guidelines that would enable companies to market off-label indications for approved products. Based on FDAMA, the FDA developed new guidelines stating that manufacturers can distribute off-label information after submitting a copy of the data to be distributed to the FDA 60 days before releasing it to the public (SCAN 6/24/98).

But implementation of the new policy has become ensnared in a legal challenge filed by the Washington Legal Foundation in 1994 against the FDA’s older off-label guidelines. The WLF’s suit claimed that the FDA’s off-label restrictions were infringing on manufacturers’ First Amendment rights. U.S. District Court Judge Royce Lamberth ruled in July 1998 that these guidelines did indeed violate manufacturers’ First Amendment rights.

But does Lamberth’s ruling apply to the FDA’s new policy? The FDA, the WLF, and Lamberth are still trying to figure that out and Lamberth delayed implementation of his July ruling until the matter is resolved. Meanwhile, companies that want to promote off-label uses for their products are in legal limbo, according to attorney Alan Bennett, a partner at the law of firm Fox, Bennett, & Turner of Washington.

At a WLF press conference last month, Bennett outlined the status of the litigation and companies’ responses to both the FDA’s FDAMA protocols and Lamberth’s rulings. Some companies seem to be ignoring FDAMA, choosing instead to proceed under Lamberth’s July ruling and risking that the FDA will not take enforcement action as long as the federal case is active, Bennett said.

In fact, since FDAMA was implemented, only about four companies have submitted off-label data to the FDA, and only two of those applications have been cleared by the agency, according to Byron Tart, director of the promotion and advertising staff at the FDA’s Center for Devices and Radiological Health.

But because Lamberth’s decision is on hold, technically companies are bound to FDAMA regulations, Bennett said.

“Companies have to evaluate every dissemination on a case-by-case basis, making sure they understand the current status of the case and the risks they might be taking,” Bennett said. “(The issue) is really in flux. And companies can’t ignore the fact that there’s a product liability risk in disseminating information that hasn’t been approved by the FDA.”