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Executive Summary

MITRE CORP. WILL REVIEW THREE EFFICACY SUPPLEMENTS for FDA as the first outside contractor for reviews of drug applications. MITRE Corp., a non-profit firm based in Bedford, Mass., has agreed to undertake the reviews at a cost of $221,608 under a contract signed Sept. 24, FDA said. The funds are from fiscal 1992 appropriations. The federally-capitalized firm is not required to offer competitive bids for certain government contracts. FDA's Center for Drug Evaluation and Research apparently has not decided which three efficacy supplements will be farmed out to MITRE. Some or all of the three supplements reportedly will be for analgesic products. MITRE will be given deadlines for completion of the reviews when FDA hands over the supplements, the agency said. HHS Secretary Sullivan, speaking last November at a press briefing to introduce FDA reforms proposed by Vice President Quayle's Council on Competitiveness, said that contractors would be given a "strict 180-day deadline" for completing the reviews ("The Pink Sheet" Nov. 18, 1991, p. 3). The contractor may not get the supplements until the end of October, FDA said. The external review pilot program is behind schedule. When the proposal was made last November, the agency predicted that it could have the first four applications farmed out to a contractor by May 1992. FDA has been negotiating with MITRE since April ("The Pink Sheet" April 13, p. 14). The outside reviews are being done under a demonstration program to test the feasibility of such reviews as a way of dealing with therapeutic areas that have the greatest backlogs. A report by the House Government Operations/Human Resources Subcommittee on the initiatives proposed by Vice President Quayle's Council on Competitiveness in November 1991 recommends halting implementation of the council's proposal that FDA contract out drug application reviews until the public has an opportunity to comment on the plan (see following T&G). Dissenting views from seven minority members of the Government Operations Committee that accompany the report note that "24 entities have notified FDA of their desire to conduct these reviews."

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