FDA’s off-label regulations challenged by Washington Legal Foundation ruling

Ruling creates confusion over what vendors can say

A federal judge has overruled some of the Food and Drug Administration's restrictions on off-label promotions of medical products, only a month after the FDA proposed relaxed regulations for the dissemination of off-label information by medical drug and device firms. The ruling has created some confusion about exactly what information vendors can disseminate beyond what is already approved in a product's labeling.

The July ruling in the U.S. District Court in Washington, DC, resolved a 1994 lawsuit in which the Washington Legal Foundation (WLF) contested an FDA policy statement issued in the early 1990s. The foundation claimed that the policy restricted companies' commercial speech, specifically in the context of continuing medical education and textbook and article distribution.

In the decision, U.S. District Court Judge Royce Lamberth ruled that these policy and guidance documents issued by the FDA were not valid under the First Amendment. The judge made clear, however, that the FDA continues to have the responsibility of protecting public health, as well as preventing the distribution of false or misleading data, and suggested ways the agency could craft policy that would withstand First Amendment scrutiny.

The ruling came just weeks after the FDA suggested new off-label regulations meant to implement Congress's 1997 Food and Drug Administration Modernization Act (FDAMA), which established policy for the distribution of articles and textbooks. The FDA's proposed rules would allow companies to distribute information about off-label uses for their products, provided they submitted a copy of the data to the FDA 60 days before it was released. The rules clearly stated that the information pertained to off-label uses not cleared by the FDA (SCAN 6/24/98).

Although the July WLF ruling did not directly name FDA's new off-label policy unconstitutional, the policy could fall under the same theory of law that the judge used to overturn the older policy. The ruling could therefore challenge FDAMA and the FDA's new rules, according to Marlene Tandy, associate general counsel at the Health Industry Manufacturers Association (HIMA) in Washington, DC.

"There are those who say that, essentially, the judge has (implied) that FDAMA provisions in this area are unconstitutional," Tandy said.

According to John Kamp, senior vice president of the American Association of Advertising Agencies (AAAA) in Washington, DC, Lamberth's decision challenges the FDA's traditional exercise of its jurisdiction because it establishes, at least in one court, that the First Amendment affects the FDA's regulation of commercial speech.

"The major aspect of this decision that's important is that the judge in this case takes the position that the First Amendment applies to the FDA in this context," Kamp said. "It's a very significant ruling. Clearly the bell has rung."

On August 13, the agency filed a request to amend the judgment and stay its publication in the Federal Register, asking the court to clarify that the injunction applies only to those policies contested by the WLF, not to those set forth by FDAMA. The agency also requested that the ruling apply only to products that have been approved by the FDA for other uses, not to products unapproved by the agency.

The FDA may appeal the ruling within 90 days, but has not indicated whether it will do so. In the meantime, vendors that wish to distribute off-label information must determine for themselves what they are permitted to do under Lamberth's ruling, existing law, and the FDA's proposed regulations. n

Strong nuclear market boosts SMV

The robust nuclear medicine market contributed to SMV America's strong growth in the first half of 1998, company executives reported last month. Due to the Twinsburg, OH-based firm's sales of its variable-angle cameras and PowerStation computer systems, SMV saw its equipment and service revenues increase 36% for the first six months of the year over the same period in 1997, to more than $29 million. Unit shipments increased by 35%, and product revenues climbed 37% over the previous year. Because it is privately held, SMV is not required to report net income figures.

SMV expects continued revenue growth in the second half of 1998 as it starts shipping its Transmission Attenuation Correction (TAC) and Volumetric Coincidence Reconstruction (VCR) packages, both displayed at this year's Society of Nuclear Medicine meeting in Toronto. The company expects to install 33 TAC packages over the remainder of the year.