By Lisa Seachrist
WASHINGTON — Struck with a defeat over regulation of information concerning "off-label" uses of medical products, the FDA is assessing whether it will appeal the July 30 court decision that enjoined it from restricting the distribution to practicing physicians of peer-reviewed scientific articles on nonapproved applications of drugs and devices.
The decision handed down by the U.S. District Court in Washington raises the question whether the agency's planned methods of implementing certain aspects of the FDA Modernization and Reform Act of 1997 are constitutional. In the act, Congress mandated that the agency permit dissemination of off-label information.
"There is really not much we can say now," said Brad Stone, a media spokesman for the FDA. "We are analyzing the ruling and talking with the Justice Department about our options. We aren't sure what effect it will have on the implementation of [the FDA Modernization Act]."
The agency has 90 days to file an appeal of the decision.
The suit was filed in 1994 by the Washington Legal Foundation (WLF), a public-interest law and policy center that defines its mission as "defending the rights of individuals and businesses to go about their affairs without undue influence from government regulation."
In its complaint, WFL claimed the FDA's current policy of preventing drug and device manufacturers from distributing reprints of text books and peer-reviewed information about off-label uses of medical products violated First Amendment rights to free speech.
While physicians have been able to request such information from the company, manufacturers are not currently allowed to send the information unsolicited.
Court Says FDA Exaggerates Power
In siding with the plaintiff, Judge Royce Lamberth decided that while the agency desired to regulate promotion by manufacturers and encourage manufacturers to seek additional indications for the label, it could not place restrictions on free speech.
In issuing the injunction, Lamberth prevents the FDA from restricting the dissemination of reprints from peer-reviewed professional journals and reference textbooks.
In addition, the agency may not prevent medical product manufacturers from suggesting content or speakers to an independent program provider for a continuing medical education (CME) symposium.
"I was extremely pleased with the ruling," said Richard Samp, chief counsel at WLF. "Judge Lamberth gave us 100 percent relief."
The FDA argued scientific and educational activities conducted by manufacturers without FDA oversight were "inherently misleading."
Lamberth wrote: "In asserting that any and all scientific claims about the safety, effectiveness, contraindications, side effects, and the like regarding prescription drugs are presumptively untruthful or misleading until the FDA has had the opportunity to evaluate them, FDA exaggerates its overall place in the universe."
Samp agreed, noting, "The court rejected the idea that the FDA is the font of all medical knowledge in this country."
The FDA will be allowed to require manufacturers to provide conspicuous notification that uses under discussion have not been approved by the agency; require articles to come from bona fide peer-reviewed journals; require textbook reprints to come from independent publishers; and require sponsors of CME symposia to be independent program providers.
The agency also may require manufacturers that sponsor or support dissemination activities to disclose their interests in the discussed drugs. The FDA will maintain its ability to take action against companies that distribute false or misleading information.
However, the ruling does raise questions about the implementation of the FDA modernization law. The agency was prepared to allow very restrictive dissemination of information, as long as the companies committed to filing a supplemental application for the use discussed and submitted the articles for distribution to the agency prior to distribution. Lamberth's ruling clearly prohibits such measures.
"Do I think that [FDA Modernization Act] on the whole is constitutional? I have no opinion on that," Samp said. "I do think that FDA's plans to implement [the law] are totally contrary to congressional intent. The [FDA Modernization Act] as interpreted by the FDA is unconstitutional." *