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Executive Summary

FDA will be able to double its ANDA approval output once it brings online 15 new chemistry reviewers, FDA's Office of Generic Drugs states in a management plan submitted to Rep. Dingell's (D- Mich.) Energy & Commerce/Oversight subcommittee on July 19. "Preliminary estimates suggested that with the addition of 15 additional reviewing chemists (approximately 50% more than the current number), the rate of approvals . . . could increase to about 20 per month," the management plan states. FDA is currently averaging approximately 10 ANDA approvals a month. FDA notes in the management plan, however, that it "does not expect to recruit all 15 chemists and have them fully productive by the end of 1991" due largely to the "difficulty in attracting reviewing chemists to the agency." However, the Office of Generic Drugs promised to "intensify" its recruitment efforts "over the next several months." In addition, the plan states that the office "will seek direct hire authority for chemists to cut through cumbersome hiring procedures." FDA's Office of Generics has come under fire recently from Congress for taking so long to get back up to speed in its generic drug application reviews in the wake of the generic scandal. At a June 5 hearing before Dingell's Energy & Commerce/Oversight subcommittee, both Dingell and Sen. Orrin Hatch asked for a six month management plan that would serve as a blueprint to correct agency review procedures. Hatch threatened "draconian steps" if FDA did not make an effort to quickly "clean up its own act." The plan to add 15 new chemists by the end of the year is one of 11 "short-term" initiatives outlined in the management plan. Like the program to increase the number of chemistry reviewers, several of the initiatives have been discussed before by the agency. New ideas in the plan include the establishment of a tracking committee that meets twice a month to review the status of ANDAs/AADAs that have been recommended for approval by the primary reviewing chemist. FDA noted that since the tracking committee began meeting "final reviews and sign-offs routinely occur in less than one month." Also, representatives of the Office of Generic Drugs are now holding weekly meetings with the Office of Compliance "to review priorities and outstanding requests for product clearance." The management plan also notes that the agency is making an effort to deal with the backlog of ANDAs that have been at the agency for some time. Office of Generic Drugs Deputy Director Douglas Sporn is now meeting on a monthly basis with "appropriate office staff to monitor progress on reviews of the 25 to 50 oldest pending ANDAs and AADAs," the plan points out. In addition, the plan includes an initiative to "streamline" the ANDA supplements review process that is targeted for implementation in August. Long-term initiatives outlined in the management plan include FDA's consideration of generic monographs and a new review procedure for "blockbuster" generic drugs -- both of which appeared in Federal Register notices in June; the creation of a new training branch for ANDA reviewers; legislation to increase salaries of FDA reviewers; improved communication within the Office, including a management retreat tentatively scheduled for this fall; a pilot program to approve ANDAs with fewer review cycles; and a reassessment of criteria for initial screening of applications. The prescreening program, instituted last year, currently turns away about 10% of new ANDAs/AADAs before they are filed. FDA is relooking at the screening criteria "to be sure the most common deficiencies are in fact being looked for and identified." FDA also is working on technology upgrades for the Office, including an electronic filing system for bioequivalence reviews. FDA said that such a system "will permit completed reviews to be stored and retrieved in electronic form on a shared basis and using keyed searches." The management plan predicts that a test version of the system "will be operational by Dec. 1." The electronic filing system will be part of a planned network system connecting all of the Office's computers. A pilot test of the network is underway and will be completed this year, FDA said.

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