FDA remains vulnerable to future First Amendment challenges if it uses off-label reprints as evidence on misbranding cases, Judge Royce Lamberth suggested in a Nov. 30 court order.

Lamberth denied a Washington Legal Foundation petition to revoke a Federal Register notice which states that the agency can use off-label reprints as evidence in misbranding cases. However, the judge also criticized FDA's current policy as ambiguous.

"To say FDA's March 16, 2000 notice finally clarifies the situation is a farce," Lamberth pronounced. "The notice specifically invites a constitutional challenge to each and every one of its enforcement actions."

FDA's notice states that off-label reprints can be used as evidence in an FDA misbranding case unless manufacturers comply with the off-label provisions of the FDA Modernization Act.

"If a manufacturer does not comply [with Sec. 401 of FDAMA], FDA may bring an enforcement action under the FD&C Act, and seek to use journal articles and reference texts disseminated by the manufacturer as evidence," the notice states.

FDA published the notice following a Feb. 11 D.C. Circuit Court of Appeals ruling that overturned a July 1999 injunction by Lamberth. The injunction found that FDAMA's off-label dissemination provisions and its guidance on content for continuing medical education courses violated the First Amendment.

In its oral arguments, FDA convinced the appellate court that FDAMA merely created a "safe harbor" allowing manufacturers to disseminate materials without being subject to misbranding prosecution under the FD&C Act. FDA asserted to the court that FDAMA itself provided no enforcement authority.

In its April 6 petition to Lamberth, WLF argued that the agency's March 16 notice reinstates policies consistent with two "enduring materials" guidance documents that remained subject to Lamberth's original injunction.

Lamberth rejected the argument, however, noting that his injunction had been vacated completely by the appellate court. Although the court did not address the two older guidances, it overruled all aspects of Lamberth's injunction that were based on constitutional law.

"It makes little difference what the FDA's...notice contained," Lamberth wrote. "Since the injunction has been wholly vacated by the court of appeals, there is nothing for the notice to violate."

Nevertheless, Lamberth did suggest that his previous decision on the broader issue of whether FDA violates the First Amendment "by penalizing manufacturers for sending scientific literature to physicians regarding off-label uses" likely would still stand up in court if the agency brought cases based on the FD&C Act.

"The Court is confident that it has done its best at every step of the process. It has decided the underlying issue at least twice, and senses that it will be called on to do so again before the controversy is concluded."

"Given Judge Lamberth's statement that he disagrees with FDA's interpretation of the First Amendment, it is hard to believe that FDA would risk the court's wrath by adhering to its discredited policies," WLF maintained in a Dec. 1 statement.

WLF says it will wait for a specific FDA enforcement action, such as a warning letter, against a company for off-label reprint dissemination before proceeding with First Amendment litigation. Once the enforcement action occurs, however, the policy watchdog group could proceed with the case without manufacturer involvement.

While he allowed the notice to stand, Lamberth also castigated the agency for its lack of policy in the area. "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."

Sec. 401 of FDAMA requires manufacturers to submit a premarket application for the "off-label use or have certified that such an application will be submitted within the applicable statutory deadline." Companies also must "prepare and submit semi-annually to the FDA lists of the articles and reference publications disseminated."

FDA Off-Label Notice Stands, But Enforcement Still Vulnerable - Judge

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