WLF Confusion Benefits FDA By Deterring Dissemination, Bennett Says
Executive Summary
Uncertainty surrounding the federal appeals court decision in the Washington Legal Foundation v. Henney case likely benefits FDA, attorney Alan Bennett, (Bennett, Turner & Coleman), said.
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Washington Legal Foundation
WLF requests that FDA be ordered to withdraw its March 16 Federal Register notice on off-label dissemination. The notice laid out FDA's interpretation of a Feb. 11 Washington, D.C. federal appeals court ruling that vacated portions of a July 1999 decision by Washington D.C. district court Judge Royce Lamberth enjoining FDA from restricting dissemination of off-label information (1"The Pink Sheet" March 20, p. 18). The notice suggests that the agency "is no longer restricted by the court's injunction" even though part of the injunction still stands, WLF maintains
Washington Legal Foundation
WLF requests that FDA be ordered to withdraw its March 16 Federal Register notice on off-label dissemination. The notice laid out FDA's interpretation of a Feb. 11 Washington, D.C. federal appeals court ruling that vacated portions of a July 1999 decision by Washington D.C. district court Judge Royce Lamberth enjoining FDA from restricting dissemination of off-label information (1"The Pink Sheet" March 20, p. 18). The notice suggests that the agency "is no longer restricted by the court's injunction" even though part of the injunction still stands, WLF maintains
Off-Label Promotion Could Jeopardize Orphan Drug Status - Pharmacia Attny.
Pharmacia decided not to disseminate off-label information for one of its products because of a concern that its orphan status could be rescinded.