Washington Legal Foundation
This article was originally published in The Gray Sheet
Executive Summary
April 6 motion 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 vacating 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 Gray Sheet" March 20, p. 6). The notice put FDA's "spin" on the appellate decision, suggesting that the agency "is no longer restricted by the court's injunction" although part of the injunction still stands, WLF says. The organization expects a decision by mid-summer
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