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Executive Summary

FDA's goal of 20 ANDA approvals per month "is woefully inadequate" and will not fulfill the intent of the Waxman/Hatch act, Rep. Dingell (D-Mich.) commented in an Aug. 6 letter to Commissioner Kessler. The letter is in response to FDA's Office of Generics management plan, which was submitted to the Energy & Commerce/Oversight Subcommittee on July 19 at the request of Dingell and Sen. Hatch (R-Utah) at a June 5 hearing of the subcommittee ("The Pink Sheet" June 10, p. 10). Among the initiatives in the plan is the hiring of 15 new chemistry reviewers, which the Office of Generics said would allow it to double its output of ANDA approvals to about 20 a month ("The Pink Sheet" July 29, p. 12). The management plan for improving the efficiency of the Office of Generics has a total of 15 "short-term" and 11 longer-term initiatives. Other initiatives in the plan include the establishment of a new reviewer training program and the creation of a committee to meet twice monthly to track the status of applications. Dingell asked Kessler in the letter to "direct the Center for Drug Evaluation and Research to develop alternatives to resolve, on a more timely basis, the backlog which continues to plague the Office of Generic Drugs." Although FDA should not approve "defective" generic drug marketing applications, Dingell said, it should be able to review and approve more products each month than proposed. "The agency has had over three years since the generic drug scandal was first uncovered to get the approval process fixed and provide a meaningful number of low-cost generic alternatives to the marketplace," he pointed out. Dingell added that "the subcommittee staff's analysis of 226 chronologies of generic drug reviews and the agency's own testimony regarding its backlog make it clear that management problems continue to plague the Center for Drug Evaluation and Research as well as the Office of Generic Drugs." Furthermore, Dingell continued, the plan's goal of 20 ANDA approvals per month "is questionable" because FDA did "not attempt to quantify the impact of each of its proposed steps on new ANDA approvals or even on the backlog" of applications. The letter estimates that the rate of 20 ANDA approvals per month would still be about one-third the rate of approvals turned out by FDA prior to the generic drug scandal. Dingell said his subcommittee "has been promised repeatedly that reforms would soon produce results." For example, he noted, although HHS Secretary Sullivan testified at a July 1990 hearing that improvement in the rate of generic approvals would be seen "within a few months," results "have lagged badly." The letter also asks Kessler to submit monthly progress reports to update the Oversight Subcommittee on the status of each of the management plan's 26 initiatives. Dingell criticized the management plan for lacking "a timeframe for achieving even its limited goals." Without a schedule, "the extent of any continuing resource problem and the nature of any continuing management problem will be more difficult to discern," Dingell reasoned. "Accordingly," Dingell asked Kessler to provide the subcommittee with monthly progress reports, "beginning Sept. 1, 1991, on each of the 26 initiatives identified" in the management plan. The reports "should include updated timetables for implementing each initiative and the estimated impact on approvals and/or the backlog, the status of approvals and backlog, and any initiatives to produce productivity," the congressman suggested.

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