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FDAMA off-label data provisions likely to be revisited in drug user fee reauthorization -- Hutt.

This article was originally published in The Gray Sheet

Executive Summary

FDAMA OFF-LABEL JOURNAL REPRINT CLAUSE MAY BE REVISITED IN PDUFA III DISCUSSIONS in 2002, Covington & Burling attorney Peter Barton Hutt told attendees of a Management Forum seminar on the FDA Modernization Act in London Jan. 19. Debate over the off-label promotions clause will "likely be reopened" when discussions begin for a third reauthorization of the Prescription Drug User Fee Act because the clause "will not be as useful as Congress intended," Hutt maintained. The provisions are "very unsatisfactory [and] very restrictive."

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