ARTICLE | Politics & Policy

Federal court upholds FDA off-label regulations

December 6, 2000 8:00 AM UTC

A federal court has ruled that FDA's policies on the dissemination of information about unapproved (off-label) uses of approved products are legal, but he also said they provide companies with no clear guidance on the subject and are likely to be challenged in court. Judge Royce Lambreth of the U.S. District Court for the District of Columbia on Nov. 30 denied the Washington Legal Foundation's request to prevent FDA from enforcing off-label policies that were promulgated earlier this year. Lambreth stated that the agency can pursue its policy of granting a "safe harbor" to companies that obtain clearance prior to distributing scientific studies about off-label uses. Lambreth noted, however, that despite years of litigation and enactment of legislation, FDA's authority to restrict dissemination of information on off-label uses is unclear. "After six years' worth of briefs, motions, opinions, Congressional acts, and more opinions, the issue remains 100% unresolved, and the country's drug manufacturers are still without clear guidance as to their permissible conduct," Lambreth wrote.

Lambreth criticized a notice FDA issued in March outlining its off-label policy. "To say that the FDA's March 16, 2000 Notice finally clarifies the situation is a farce; the Notice specifically invites a constitutional challenge to each and every one of its enforcement actions. That is no way to establish policy on an issue that both sides argue is of--quite literally--life and death proportions," Lambreth wrote. ...