FDA's intention to use journal reprints distributed for off-label indications as evidence in misbranding enforcement actions violates the standing injunction on two "enduring materials" guidance documents, the Washington Legal Foundation contends.

The policy watchdog group plans to file a motion soon asking Washington D.C. district court Judge Royce Lamberth to clarify and enforce his July 1999 injunction against the two documents, which restrict the dissemination of off-label information in reprints and textbooks (¹ Also see "Off-Label Dissemination Still Must Disclose Interest, Unapproved Status" - Medtech Insight, 2 August, 1999.).

Statements made by FDA in a March 16 Federal Register notice indicate that the agency plans to reinstate policies consistent with the guidance documents, thereby violating the injunction, WLF asserts.

The notice establishes the agency's interpretation of a Feb. 11 ruling by the D.C. circuit court that vacated portions of Lamberth's decision. The appeals court ruling resurrected the FDA Modernization Act's off-label provisions and its implementing regulations, which Lamberth had enjoined, as well as an agency guidance on manufacturer involvement in continuing medical education (CME) programs. The agency did not appeal Lamberth's injunction of the older guidances on reprints and textbooks, claiming they had been superseded by the FDAMA provisions.

The court based its ruling on the assumption that FDA would only implement Sec. 401 of FDAMA as a "safe harbor" for off-label dissemination, and not as an enforcement tool. FDA's notice is the only current guide for manufacturers attempting to understand the agency's enforcement policy on off-label reprints.

The notice confirms that "if a manufacturer fails to proceed under Sec. 401, that failure does not constitute an independent violation of law." However, "if a manufacturer does not comply, 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."

WLF argues that the use of reprints as evidence was never authorized by the circuit court's Feb. 11 ruling. The court's statement that "FDA retains the prerogative to use [reprints] as evidence" is merely a restatement of FDA's oral arguments and is not intended to hold legal force, the group maintains.

WLF Will Use FDA Notice On Circuit Court Ruling As Wedge To Reopen Case

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