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Executive Summary

FDA needs an agency-wide automated regulation tracking system to "improve internal management oversight of the FDA regulation process," the General Accounting Office said in a report released at an April 1 hearing of the House Energy & Commerce/Health subcommittee. The GAO report recommends that the tracking system monitor progress on all regs in each of FDA's five centers; generate recurring reports to top agency officials and center directors; and serve as "the primary basis for identifying delays in issuing regulations and initiating appropriate actions, when necessary, to overcome internal delays in development of individual regulations." The recommendation follows a GAO analysis of FDA's timeliness in issuing regulations. Requested by Subcommittee Chairman Rep. Waxman (D-Calif.) last year ("The Pink Sheet" Feb. 4, 1991, T&G- 9), the report finds that the agency has a backlog of several hundred proposed regs that have not been acted upon and takes "considerable time" even to issue regs that have been given high- priority status. GAO reported that as of April 1991, 301 FDA-proposed regulations had been published in the Federal Register but had not been finalized. In addition, at that time there were 87 regs under development. According to GAO, the 301 regs had been pending, on average, for nine years. "Nearly three-fourths (217)" of the 301 proposals "have been pending for more than five years, waiting for FDA to make changes before issuing them in final form." Two regs had been languishing for 29 years, GAO noted. Disregarding the 89 inactive proposals FDA eliminated last year ("The Pink Sheet" Jan. 6, 1992, In Brief), proposals still remaining have been pending an average of seven years, GAO Associate Director for National and Public Health Issues Mark Nadel testified. Regulations proposed pursuant to statutory mandate, usually with deadlines for publication, take an average of four years to be published in final form. Waxman commented in his opening statement: "Any way you cut it, FDA regulations take an extraordinarily long time -- far too long -- to complete." Waxman called the hearing to focus on FDA delays in issuing regulations, particularly those pertaining to OTC drugs and medical devices. Waxman noted that regs to implement the Orphan Drug Act of 1983 "are still outstanding," and regs required under the 1984 ANDA/patent law remain pending. Furthermore, the OTC Review, "begun 20 years ago, is less than half complete." FDA Commissioner Kessler noted in his testimony that Deputy Commissioner for Policy Michael Taylor is developing efforts to coordinate development and publication of regulations in his newly-created post, established in July 1991. As part of his streamlining efforts, Taylor last year created an FDA regulations council to oversee the issuance of regs. Kessler also noted that the withdrawal of 89 inactive proposals has given FDA managers "a clearer picture of where resources need to be focused to expedite the rulemaking process." Regarding the OTC Review, Kessler said "20 years is long enough" to complete the final monographs. "We have projected that we can publish 75% of the final OTC monographs by the end of 1993 and 90% by the end of 1994." Kessler noted that 20 OTC regs "are projected to be published in 1992." Waxman asked about the influence on FDA's policy decisions of the Vice President's Council on Competitiveness. He noted that FDA is drafting regs for institutional review board (IRB) review of INDs, as recommended by the council. IRBs currently assess only the ethical implications of proposed research and monitor compliance with informed consent requirements. Waxman asked whether Kessler thinks IRBs are capable of complete reviews of INDs. The commissioner replied that IRBs cannot review INDs "as currently structured," but said that the regulations will establish standards for IND reviews. Noting that the proposal predates the council, Kessler said IRB reviews will encourage research by individual physicians who are intimidated by the prospect of dealing with the agency. Negotiations between FDA and the Competitiveness Council over the IRB proposal are documented in official FDA memoranda entered into the record of the House Governmental Operations/Intergovernmental Relations subcommittee. The documents, released at a March 19 hearing on the influence on FDA policy decisions by the council, suggest that Commissioner Kessler acquiesced to the council in broadening the IRB proposal so that it applies to all Phase I studies. Intergovernmental Relations subcommittee Chairman Weiss (D- N.Y.) said the documents indicated that the council persuaded FDA to loosen many drug review requirements in an effort to speed approvals ("The Pink Sheet" March 23, p. 3). A Nov. 5, 1991 memorandum from the Competitiveness Council to FDA Associate Commissioner for Policy Coordination William Hubbard incorporates final changes in the proposal that were agreed to by Kessler. The memo states: "Pursuant to this recommendation, FDA will immediately permit sponsors to submit their INDs involving Phase I studies of patients." The word "healthy" is crossed out immediately preceding "patients," and seems to indicate that Kessler agreed to broaden the IRB proposal so that IRB-only review would not be limited to studies of healthy volunteers. The memo was sent a little more than a week before the Nov. 13 announcement of the council's recommendations ("The Pink Sheet" Nov. 18, 1991, p. 3). The IRB proposal is not limited to healthy study subjects in the final council report. However, Kessler managed to persuade the council to restrict its original IRB proposal. In a January 1991 memo, the commissioner noted that the council had recommended "broad deregulation (all early-phase INDs and all 'noncommercial' INDs, regardless of phase)." Kessler said FDA was "concerned that broad deregulation that would include large studies in humans would subject us to criticism that we are exposing patients to unreasonable risks."

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