FDA Physicians Are Alerting Agency To "WLF" Off-Label Promotions

FDA is being alerted to off-label promotions that have not cleared the agency ad division by agency staff who are on promotional mailing lists, FDA Division of Drug Marketing, Advertising & Communications Director Minnie Baylor-Henry told a recent Food & Drug Law Institute meeting.

"The doctors that work for FDA are still on the mailing lists and they are more than happy to provide us with these reprints. We are getting these from multiple channels," Baylor-Henry said.

Promoting off-label applications is permitted under Sec. 401 of the FDA Modernization Act of 1997, but specific criteria, including pre-submission to the FDA ad division, must be followed (see preceding story).

However, some companies are conducting off-label campaigns under the less controlling procedures suggested by the D.C. District Court in its July 1998 decision in the Washington Legal Foundation challenge ("The Pink Sheet" Aug. 3, 1998, p. 8).

"There are clearly companies that have decided to take 'the WLF path,'" Baylor-Henry said. These firms have "decided not to submit these particular reprints to FDA for comments. We know this is happening pursuant to the WLF decision. There are companies that are actually sending these in pursuant to 314.81 and we appreciate that...but we know that it is not always happening," she said.

Baylor-Henry did not say whether the agency had meted out any penalties for off-label promotions. Because the WLF case is still pending, the compliance rules are unclear. It is a "very difficult time for you in the industry and a difficult time for FDA also," Baylor-Henry said. "We are both hanging out there waiting for the answer."

D.C. District Court Judge Royce Lamberth has yet to decide to what extent the Sec. 401 off-label dissemination provisions and the implementing regs conflict with his July 1998 decision. Lamberth has stated that FDAMA is subject to his decision, but the court has not elaborated on that determination ("The Pink Sheet" March 1, p. 26).

Both FDA and WLF have filed briefs in the continuing case. The agency has argued that Sec. 401 is an extension of the principles upheld in Lamberth's July order, while WLF has maintained that FDA had a large role in crafting FDAMA and thus the law perpetuates the spirit of the guidances rejected by the court ("The Pink Sheet" May 10, p. 24).

On May 13, FDA filed a further response to the WLF arguments. The agency asserts that its charter calls for it to balance first amendment issues with "protecting public health and safety."

The Washington Legal Foundation "is incorrect," FDA contends, "in assuming both that the sole regulatory scheme acceptable is that set out in the July 30 order, and that FDAMA must be unconstitutional because it may have similarities to the policies reflected in the guidance documents originally at issue."

Although the court did recognize that manufacturers face sufficient marketplace incentives to compel supplemental applications, FDA says, "WLF fails to address the fact that Congress examined the issue for years, and studied aspects not before the court such as patient notification, generic competition, and costs, among others."

FDA suggests that the court's decision as to whether FDAMA violates the July 1998 order should accord "deference" to the law enacted by Congress.

The agency also takes issue with WLF's contention that "Congress largely acceded to FDA's views" when drafting FDAMA.

"WLF's unsubstantiated statements that in enacting FDAMA Congress merely did FDA's bidding is preposterous, insulting to Congress, and overwhelmingly contradicted by the legislative history," the filing states.

"Contrary to WLF's arguments, Congress has over a period of years closely examined the issue of manufacturer dissemination of information about off-label uses to physicians and is attuned to any perceived efforts to hamper physician access to such information."

Among the legislative events behind the 1997 act were Senate hearings in 1996 at which substantial input was offered from the medical community, FDA notes.

"Congress heard testimony from several physicians" and input gathered by Sen. Jeffords (R-Vt.) from "various professional organizations, such as the American Medical Association and the American Cancer Society, among many others, as well as a Roper poll of oncologists." Sen. Frist (R-Tenn.) also cited physician testimony at committee hearings, FDA noted.

The emphasis on physician input in FDA's filing reflects the agency's insistence that WLF represents physicians, not manufacturers. The May 13 filing argues that WLF does not have legal standing to represent the commercial speech interests of drug companies because they are not its constituency.

"WLF has no standing to advance the interests of drug and device manufacturers, who took no action to intervene in this case," FDA contends. "The only group WLF has standing to represent in this case is its physician members."

"WLF does not explain how its physician members will be harmed by FDAMA's requirement that FDA ensure that those physicians get a complete and balanced presentation of information about an off-label use," FDA stated.

"Indeed, although it is not difficult to anticipate manufacturers objecting to the FDAMA provisions that require that additional material be disseminated about off-label uses, it is odd that WLF's physician members would object to receiving such material," the filing continues.

"Therefore, WLF's vigorous objections to FDAMA's requirement that manufacturers disseminate to physicians material over and above that required by the July 30 order should be viewed skeptically," the brief concludes.

WLF contends that FDAMA delays physician access to information, therefore having a negative effect on its constituency.

WLF also maintains that there is Congressional discontent about FDA's interpretation of FDAMA. The advocacy group says that, since enactment of the statute, several lawmakers involved in the process have voiced concerns that FDA's implementation has been more restrictive than intended.