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FDA LOOKING AT LIMITING IRB CLEARANCE OF INDs TO SINGLE- INVESTIGATOR STUDIES OF DRUGS ALREADY IN ADVANCED TRIALS; FDA TO SEEK COMMENTS ON BROADER IRB USE

Executive Summary

FDA is currently looking at a proposal to narrowly expand the agency's reliance on institutional review board clearance of INDs in response to the Council on Competitiveness' recommendation, FDA Center for Drug Evaluation and Research Deputy Director for Medical Affairs Bruce Burlington indicated at a July 20 meeting sponsored by the FDA Council. FDA's "current intent," Burlington explained, "is to propose something that will offer some relief from the paper work burden to academicians, in particular, where we can reach an assessment" that additional FDA review of an IND is not needed to protect patients. FDA's thinking is to allow IRB reviews of INDs when a chemical compound is "already in controlled clinical trials -- Phase II/III trials -- and an academic investigator wishes to undertake an initial clinical evaluation for a different indication." He added that the "exact shape and form" of this proposal "is not yet certain because we're still working on it." The proposal, when ready, will go through notice and comment rulemaking, he said. FDA is considering the transfer of some its IND reviews to IRBs as one part of the agency's efforts to implement the November 1991 recommendations of Vice President Quayle's Council on Competitiveness. Burlington said that the agency is "looking at a variety of things that could be done to implement the spirit of this recommendation and we are in the process of drafting proposals." In addition, FDA will publish a series of questions in a future Federal Register notice asking how the agency can "undertake the full reform [related to IRB reviews] recommended by the Competitiveness Council," Burlington said. He noted that the questions "will highlight problem areas" identified by FDA's internal task force "as potential vulnerabilities in implementing the recommendation as it came from the Competitiveness Council." Burlington pointed out that FDA sought comment on the idea of transferring FDA responsibility for INDs to institutional review boards long before the Competitiveness Council recommendations. He pointed out that the agency "received really very substantially negative comment on previous proposals." Burlington also updated the Capitol Hill audience on FDA's progress in implementing other Council recommendations, including the accelerated approval format proposed in an April 15 Federal Register notice ("The Pink Sheet" April 20, p. 6). He noted that FDA has received "some 40 comments" (see related story, p. 8) and that the agency is "currently in the process of beginning an analysis of those [comments]." Burlington suggested that FDA may be able to forward the final proposal "out of the agency ...in a few weeks," although he acknowledged "that it's hard to predict how rapidly these things go." On the Council's recommendation to contract out drug reviews, Burlington reported that the agency is currently in negotiations with a sole source contractor under a pilot program to review the feasibility of outside reviews. FDA reported in April that it was in discussions with Bedford, Mass.-based MITRE Corp., a non-profit firm that is not required to offer competitive bids for government contracts ("The Pink Sheet" April 13, p. 13). Representatives from MITRE met with FDA Deputy Commissioner for Operations Jane Henney on July 15 in a meeting described as a "courtesy visit." Reportedly, FDA is currently thinking of assigning an efficacy supplement review to MITRE as part of the agency's pilot testing of external reviews. MITRE has not yet signed a contract. FDA also sought competitive bids for outside reviews in an April 1 notice in Commerce Business Daily. Burlington said that the agency received 24 responses. However, he added, "moving forward on the competitive arm of contracting is probably going to be delayed in no small part because we do not have identified money to pay for these contracts." He explained that FDA does not believe "it would be a useful exercise to ask these private companies to pull together and write contract offers if we are not prepared to let a contract because we don't have funding for it." In addition, Burlington pointed out that FDA has been stymied in implementing the Council's recommendations to acquire and establish updated computer networks to improve the agency's management operations due to a lack of funding.

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