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Washington Legal Foundation

Executive Summary

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

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