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Executive Summary

The federally-capitalized MITRE Corp. may participate in FDA's pilot program for external reviews of NDAs and PLAs, according to an April 1 notice in the Commerce Business Daily. FDA said in the notice that it "has a requirement for a pilot program to conduct complete and/or partial external reviews" of NDAs and PLAs. It "intends to procure these services from the MITRE Corporation," the notice says. MITRE is a non-profit firm based in Bedford, Mass. that does not have to bid for certain government contracts. MITRE has annual revenues of about $500 mil. from its contracts with the Defense, NASA, FAA and other government agencies. FDA and MITRE are apparently still exploring whether the firm will be capable of and interested in conducting the reviews. Regardless of whether MITRE receives a contract, the agency will look for other participants for the pilot program as well, FDA said. On April 3, FDA published a solicitation for information about other firms interested in conducting external reviews. Interested firms are asked to provide: (1) "identification... of key staff to be involved"; (2) "methods to insulate involved contractor staff from conflicts of interest"; and (3) "capability to undertake complete or partial multidisciplined NDA and PLA reviews." The notice states that "responses will not be considered as either bids or proposals; cost or pricing data need not be submitted. All qualified sources will be solicited" when FDA is prepared to accept bids. The closing date for responses is 60 days after publication, or June 3. Vice-President Quayle's Council on Competitiveness issued the external review proposal in November ("The Pink Sheet" Nov. 18, 1991, p. 3). At an April 9 press conference, Quayle, FDA, and HHS announced the progress on this and other Competitiveness Council proposals (see related stories). The external review program appears to be slightly behind schedule: in November, FDA proposed to begin external review of the first four applications by this May. Quayle stressed at the press conference that FDA would make the "final determination" on approving externally reviewed applications. However, Rep. Weiss (D-N.Y.) continued to criticize the external review concept. In an April 9 statement, Weiss said the proposal "may jeopardize public health if, as originally designed by the Quayle Council, FDA would be prevented from scrutinizing safety data."

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