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FDA SAYS IT WILL REDUCE MONTHLY BACKLOGS OF OVERDUE NEW DRUG APPLICATIONS UNDER ACTION PLAN PHASE III; OLDEST PENDING APPLICATIONS WILL BE PRIORITY

Executive Summary

FDA's Action Plan Phase III pledges a reduction in backlogs of overdue NDAs and efforts to approve long-standing NDAs at the agency. According to the Action Plan, released May 22, the Center for Drug Evaluation and Research (CDER) will "reduce the mean monthly backlogs of overdue NDAs" as part of CDER's efforts to improve the efficiency and timeliness of the drug review process. The center also plans to cut down on the backlogs of past due manufacturing/control supplements and effectiveness supplements. The Action Plan also calls for CDER to: complete work on the oldest pending overdue NDAs; "reduce the backlog of antibiotic analyses;" improve the processing of original and supplemental ANDAs and bioequivalency reviews; and concentrate the agency's regulatory research on "issues that may help to evaluate products earlier." Action Plan Phase III is divided into eight sections: AIDS, biotechnology, food safety and quality, human drug program, medical device program, veterinary product safety, imports, and the commissioner's special initiatives. The first priority of the Action Plan is AIDS. The Action Plan outlines FDA's current strategy for dealing with new AIDS therapies and vaccines based on the fully implemented Bush initiative to expedite approvals and Treatment IND regulations. FDA says it will establish an AIDS Program Advisory Committee that will provide advice on policy issues regarding FDA activities for AIDS ("The Pink Sheet" March 13, "In Brief"). In line with the expedited approval process for drugs for life-threatening or severely debilitating diseases, FDA has been identifying candidate drugs for the process and tracking these designees through the management information system. The Action Plan notes that the agency will "prepare a monthly compilation of . . . designees for distribution to all appropriate FDA organizations." In the area of generic drug reviews, the Action Plan notes that FDA is upgrading the procedures used in the review of generic drugs, due in part, to the investigation into generic approvals by the HHS Inspector General's Office and Rep. Dingell. In March, FDA's generic drug division released a guidance outlining the new procedures ("The Pink Sheet" March 20, p. 5). The procedures were developed in response to recommendations made by an agency task force, headed by Acting Deputy Commissioner James Benson, created to evaluate the ANDA review process. Regarding OTC drug products, the Action Plan says that FDA will "begin an Advisory Panel review of OTC oral health care drug products bearing antiplaque and antiplaque-related claims." OTC Drug Evaluation Division Director William Gilbertson, PharmD, announced over a year ago that FDA was in the process of adding an amendment to the charter of the Dental Devices Panel so that it can review antiplaque products. FDA said it will continue to hold meetings with consumers, academicians, and industry "to determine future directions of OTC medicines." The agency has co-sponsored several symposiums with the Nonprescription Drug Manufacturers (formerly the Proprietary) Association on Rx-to-OTC switches and the future of self-medication, most recently in February 1988. The commissioner's special initiatives in the Action Plan focus on human resources and geriatric drug use and testing. In the last year, FDA has accelerated its efforts to improve the recruitment and retention of medical, scientific and support personnel, including the signing on of an outside search firm for the hiring of top positions within CDER ("The Pink Sheet" Aug. 29, p. 9). The Action Plan says that FDA will evaluate the use of this hiring mechanism and "determine other medical and scientific occupations where contract recruiters should be used." The Action Plan also contemplates the use of "finders fees" to encourage FDA personnel to recruit new talent for the agency. Under the incentive awards program, FDA employees will be encouraged to recruit for "hard to fill positions" in return for "modest monetary rewards." The Action Plan suggests implementing a sabbatical program for certain agency employees. According to the plan, sabbaticals will be allowed "for the purpose of conducting individualized projects, gaining insights on how FDA duties and responsibilities relate to broader governmentwide issues and/or enhancing and revitalizing the employee." Sabbaticals could be taken at universities, research institutes or other Public Health Service agencies, the Action Plan notes. FDA is considering a work-at-home program, because of the agency's overall lack of office space. The agency will determine whether it is feasible to have "segments of the employee population perform their duties in their own home environment," the Action Plan states. FDA noted that electronic transfer of information makes it possible for employees at home to stay in contact with offices. FDA suggested that concerns about the safekeeping of confidential trade information can be reasonably addressed. Regarding the Commissioner's special initiatives for the elderly, the Action Plan said that FDA, together with the National Institute of Health, "will focus its attention on the need to encourage research and work with the industry to expedite the availability of safe and effective drugs to treat serious, life-threatening diseases." FDA said it will also work with institutional review boards to protect elderly patients participating in clinical trials. Also, FDA Women's Health Initiative will have a national conference to "establish a baseline of information about health and the older woman." The Action Plan pointed to some of CDER's accomplishments in the area of elderly medicine. CDER conducted a "survey of the professional labeling of some 425 selected drugs for geriatric information." Preliminary data from the survey "indicate that half (212) of the products surveyed contained geriatric information." Results of the survey and its analysis are expected to be published in 1989," the plan notes.
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