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KESSLER SHOULD RE-EVALUATE SEPARATE CENTERS FOR DRUGS AND BIOLOGICS -- EDWARDS' SUBCOMMITTEE RECOMMENDS; "CONDITIONAL" APPROVALS ALSO SUGGESTED

Executive Summary

FDA Commissioner Kessler should assess whether the presently separate centers for drugs and biologics are "appropriate" given the impact new biotechnology products will have on the agency, the Edwards Committee's drugs and biologics subcommittee recommended in its report to the full committee. "The subcommittee believes that changing technology may make it necessary to revisit the structure that frames the decisionmaking and review activities of the two centers," the report states. "The commissioner should consider whether two separate centers are appropriate; at a minimum, enhanced coordination is crucial." The subcommittee indicated concern that FDA's current division of labor for biologics and drugs might affect the consistency of product reviews. It stressed that "while it is not necessary for the centers to use identical procedures, some changes may be needed to increase the conformity of the two centers' review processes." In addition, the subcommittee suggested that FDA "develop clear and consistent ground rules for where new products will be evaluated" so that the agency can handle the expected tidal wave of new biotechnology products. The differences and advantages of the two centers were discussed by the subcommittee at its Nov. 8-9 meeting ("The Pink Sheet" Nov. 26, p. 5). The drugs and biologics subcommittee's report was presented to the full Edwards Committee at the panel's Dec. 17-18 meeting ("The Pink Sheet" Dec. 24, p. 14). The subcommittee on medical devices, radiological health, and biomedical research and the subcommittee on foods, cosmetics, and veterinary medicine similarly presented reports. A Booz Allen study of CDER and CBER resources and activities, presented at the first day of the committee meeting, suggests that CDER should adopt some of CBER's review procedures to become more efficient. Booz Allen VP Mary Jo Veverka pointed out that "to some extent there is a rule" in CBER to have early interactions with sponsors but this practice is "highly variable" in CDER. "CDER is moving in that direction, but it could move at a much more aggressive pace." While early interaction is "actively promoted by CDER staff/management, [but] receptivity varies by division [and is] hampered somewhat by resource constraints and lack of policies and guidelines." According to the study, early meetings with sponsors can cut three to six months or more off review times. Veverka noted that both centers have initiated steps to improve the review process, including the use of a project management approach and computer-assisted product applications. In addition, CDER is trying out NDA Days and other review experiments in the Pilot Drug Evaluation Staff. Regarding these experiments, Veverka said "they don't have enough evidence of significant improvement" in time of review "but [industry] does speak encouragingly of it." She added that "if anything, [these efforts] are too low key. They're not being agressive enough" in pushing them. Use of computer-assisted applications in both centers can potentially "reduce medical review time by 15-25%" assuming a well-organized submission and a database of 1,500-2,500 patients, the study notes. The subcommittee report suggests that granting "conditional approvals" would be one way to speed up reviews. "Another possible way to expedite the review process would be to develop a conditional approval designation linked to a required Phase IV post-marketing surveillance system," the report says. The suggestion for conditional approvals was suggested earlier at the subcommittee's November meeting in La Jolla. In order for the conditional approval concept to work, the subcommittee recommended that FDA be given the authority to enforce post-marketing surveillance requirements. The report states that "if drugs are approved more quickly in the early stages of study, it is a federal responsibility to see that surveillance is tightened during the post-marketing period." The subcommittee indicated that protocols should be established for post-marketing surveillance. "To increase compliance, post- marketing requirements should be clearly defined and effective ways identified to conduct post-marketing surveillance and adverse reporting through physicians." Earlier and consistent use of advisory committees might also help quicken reviews, the report advises. The subcommittee "believes that a more meaningful role for the advisory committees, up to the point of final decision making, is necessary." The subcommittee suggested that the commissioner find ways of making committee service "sufficiently attractive so that very busy, talented scientists will still find this service worth their time." FDA Associate Commissioner for Planning and Evaluation Gerald Barkdoll, PhD, presented a "wish-list" for FDA staffing needs in the 1990s. Barkdoll's handout suggested that approval times for NDAs could be reduced "to less than 12 months by increasing the number of trained scientific reviewers" by 200 FTEs (full-time equivalents), and by increasing field resources for preclearance inspections of drug manufacturers" by 14 FTEs. Barkdoll also recommended that FDA hire another 90 FTEs to enable it to interact early on with sponsors and to manage the expected influx of biomedical products. The drugs and biologics subcommittee also recommended that the FDA commissioner be given "the independence to issue his own regulations, as has been permitted in the recent past" (see related story, p. 18). In cases where "multiple reviews" of proposed regulations may be "appropriate," such reviews be conducted "in parallel, rather than serially." Regarding generic drugs, the subcommittee noted that "bioequivalence remains a key issue and it still is not assured" and that "although bioequivalence studies are extremely costly, the FDA should consider conducting at least some such studies or certifying specific labs to conduct them." The subcommittee stated that FDA should issue regulations instead of using informal guidelines. The publishing of regulations provides an opportunity for public input, the report says. The group also suggested that meetings or workshops could be held to address controversial issues when they arise. The idea of having workshops to develop standards for generic drugs was proposed by the Generic Pharmaceutical Industry Association's "blue ribbon" panel. The subcommittee said that "it is important that the agency pay close attention to, and independently evaluate, the recommendations contained in the GPIA report." The subcommittee recommended that the Commissioner "review procedures agency wide" so that problems that occurred in the Division of Generic Drugs "do not pop up somewhere else in the future." The subcommittee does not specifically recommend the establishment of an office of OTC drugs, but advises that "an added emphasis on OTC matters is appropriate at FDA." Commissioner Kessler gave a hint at his intentions for OTC drugs in his recent speech to the Food Drug Law Institute, saying that he plans to support increased "prominence" for the division of OTC drugs. On the first day of the meeting, Committee Chairman Charles Edwards, MD, told the panel that it must produce its report and recommendations for HHS and FDA more quickly than originally scheduled. Commissioner Kessler was confirmed "obviously much more rapidly than many had anticipated," Edwards noted. Consequently, "the secretary and commissioner need our report . . . soon, not next September or October [but by] perhaps February or perhaps March [or] April at the very latest." In response to a request by Edwards, committee member Richard Merrill, a former FDA chief counsel, reviewed the three subcommittee reports and drafted a list of common topics. These topics will be the basis for position papers which in turn will evolve into the committee's report. The committee plans to discuss half of the papers at the next meeting, Jan. 23-24 meeting in San Francisco. The rest will be developed for the committee's Feb. 27- 28 meeting in Washington.
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