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FDA PARALLEL TRACK PROCESS: "PROCEDURAL" STATUS

Executive Summary

FDA PARALLEL TRACK PROCESS: "PROCEDURAL" STATUS as a policy statement instead of a regulation should be evaluated by the Administrative Conference of the United States (ACUS), FDA counsel Ann Witt suggested at a March 29 meeting of the conference's Committee on Regulation. Noting that the agency's current plan is to formulate the expanded access program for AIDS drugs as a "policy statement," Witt declared: "But that doesn't mean that's the best way for us to proceed, and that seems like something that ACUS could [look at]." Witt noted that AIDS community groups "insisted that there not be a new regulation" and favored instead a less formal approach for establishing the procedures. One of the groups' concerns was that development of the policy through a formal regulation would take too long. HHS has predicted that the parallel track policy will be published in the Federal Register in early April ("The Pink Sheet" Feb. 26, T&G-4). * The ACUS committee met to discuss its March 21 draft recommendations on FDA's procedures for approval of new AIDS drugs. The committee had formulated the recommendations on the basis of a draft report prepared by Procter & Gamble attorney James O'Reilly. The P&G counsel was brought on as a consultant to prepare the report, entitled "AIDS as an Administrative Challenge: Administrative Procedure Aspects of the Expedited Review of New Drugs For AIDS by the FDA." The report, which provides an analysis of FDA's drug approval procedures and changes that FDA has implemented to address the AIDS crisis, was called for by former FDA Commissioner Young in a July address to ACUS. At the March 29 meeting, Witt and FDA Chief Counsel Margaret Jane Porter reviewed FDA's preliminary comments on the report and recommendations. Witt's suggestion that the ACUS examine the implications of a parallel track policy statement versus formal regulation grew out of one of FDA's core comments on the committee's recommendations -- that the recommendations include "suggested administrative procedures to be used in developing...new options" for expediting the AIDS drug approval process. Based on suggestions in O'Reilly's report, the committee had recommended an alternative drug development process whereby the traditional Phase I/II/III scheme would be replaced by an agreement between the drug sponsor and FDA for specific milestones of data development. "Within such agreements," the draft recommendations state, "FDA would authorize a scheduled expansion of the clinical patient population for the drug, subject to changes made necessary by adverse events experienced with the drug." In response, Porter noted in March 29 written comments that FDA staff "agreed that rather than recommend a specific drug testing mechanism, a more appropriate recommendation from a body like the Administrative Conference would seem to be a recommendation that FDA and AIDS drug sponsors explore new options in clinical trial design and drug development to expedite the drug testing and approval process." ASUC could, "with its expertise, provide suggested administrative procedures to be used in developing such options," Porter said. The draft recommendations also suggest "creation of salary incentives to attract additional cadres of skilled medical officers and other reviewers"; "improved use of the National Institute of Health's network of physicians to perform clinical studies of AIDS drugs"; and "improved use of advisory committees with specialized expertise in AIDS drugs." The committee discussed revising the advisory committee recommendation to something such as "early and complete use" of advisory committees, which would delete the implied suggestion that the committees are not adequately used at present. * The committee also discussed the possibility of adding a general statement that FDA's response to the AIDS crisis (i.e., modifying approval procedures) may provide a model for future changes to the overall drug approval process and for other government agencies facing crises. The committee agreed that O'Reilly's report should be reissued for comment after he revises it to include any changes he may wish to make based on FDA's comments. The committee will meet again in December to review its recommendations.
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