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FDA not heeding advisory committees

Executive Summary

Advisory committee recommendations are not followed by FDA as often as generally thought, Public Citizen asserts in a recent letter in The Lancet. The public interest group claims the agency's regulatory actions were inconsistent with committee recommendations 28 percent of the time based on an analysis of FDA advisory committees from Jan. 1, 1997 through June 30, 2006. The study also finds the frequency of committee meetings prior to approval of new molecular entities declined from 40 and 52 percent in 1998 and 1999 to 24 percent for the 2000-2006 period. FDA's advisory committee process has come under heavy criticism in the past year, with editorials by advisory committee members, a Public Citizen study on conflicts of interest, and a negative report from the National Research Center for Women and Families (1"The Pink Sheet" Sept. 11, 2006, p. 22)...

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