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Executive Summary

FDA will need 1,025 more full-time equivalents (FTEs) devoted to drug reviews by the year 1997 to successfully carry out the agency's review responsibilities for new drugs, generic drugs and biologics, according to a recently released FDA needs assessment study. The study, entitled "FDA Comprehensive Needs Assessment," says the agency will need a total of 2,800 FTEs for drug/biologic reviews by 1997. Such a significant increase for application review is necessary, the report says, in order "to address burgeoning research and development efforts in industry -- particularly those driven by biotechnology -- and the flood of new products about to enter the market." FDA reviewers "received 82% more applications for experimental new products in 1989 than in 1980," the analysis notes. The study adds that "FDA reviewers will be faced with the multiple objectives of reducing review times to meet statutory requirements; addressing many more new products; and passing safety and efficacy judgments on products of much greater complexity than those currently being addressed." Overall, FDA should have a total work force of 16,994 by 1997, which is approximately double the current number of employees, the assessment says. The projection of "a 17,000 person agency in 1997 would realign FDA with industry growth rates." The study points out that while the agency lost resources during the 1980s, industry was increasing its R&D efforts and product introductions. As an example, "the pharmaceutical industry doubled its R&D expenditures between 1985 and 1990 from $ 4.1 bil. to $ 8.1 bil. By 1997, R&D dollars are expected to double again, to $ 20 bil." Along with increased staffing levels, FDA will require a budget of approximately $ 1.9 bil. in 1997, or three times the amount that the agency is currently allocated, the needs assessment states. FDA also calculated that building a consolidated facility for the agency would increase the FY 1997 budget to about $ 2.3 bil. The "Comprehensive Needs Assessment" study, conducted during 1990 by FDA's Office of Planning and Evaluation, attempts to predict the agency's resource needs over the next five years. In addition, the report considers functions that FDA needs to strengthen and possible long-term goals. The needs assessment process, the report notes, involved "analyzing hundreds of unmet needs that observers inside and outside the agency recommended FDA should emphasize in the future." Outside the agency, FDA looked to congressional hearings, General Accounting Office and Inspector General reports and "FDA's many constituent groups." The report says that proposals for FDA were then screened on the basis of health risk and cost-effectiveness. FDA has not conducted a needs assessment since 1975, the study notes. The agency said it did not do an analysis during the 1980s "because it is a very resource-intensive activity, and because it seemed wasteful and frustrating to calculate actual resource needs in the face of continued cutbacks." The needs assessment "envisions an FDA in 1997 that has caught up with many neglected tasks." The analysis adds: "Constrained resources have precluded the agency from adequately meeting its responsibilities for years, and the [assessment] process identifies many backlogs and unmet needs that will require FDA to catch up." The FDA report points out that the staffing target for 1997, if realized, would "bring the agency close to the size that it would have attained if pre-1980 growth rates (which averaged 4.8 percent annually between 1973 and 1979) were sustained through 1997." Of the approximately 17,000 FTEs needed to adequately staff the agency in 1997, the study suggests that a total of 4,000 should be allocated for application reviews in all areas: drugs, biologics, devices and food additives, including 1,100 to focus on new drug applications. Currently, FDA has a total of 700 FTEs involved in new drug review functions in the Offices of Drug Evaluation, the Office of Epidemiology and Biostatistics, and in compliance for preapproval inspections. The needs assessment report calls for increasing the number of FTEs for the Office of Generic Drugs to 1,100. The generics office currently has 550 FTEs involved in drug review functions and preapproval inspections. The report suggests that doubling the staff size would allow the office to reduce the review time for ANDAs to six months and to eliminate the current backlog of 200 original ANDA filings. The study projects the need for a smaller increase in review personnel for biological products. The report recommends that a total of 600 FTEs will be needed for biologic review, up from the current level of 525 FTEs. The assessment notes that review time for product licenses "increased by 50% between 1986 and 1990 to almost 34 months." The agency believes that its enforcement/surveillance work force needs to be almost doubled to 7,500 by 1997. The assessment points out that if this target were met, "almost half of FDA's 1997 staff would be devoted to improved enforcement and surveillance of the regulated industry." Out of the 7,500 FTEs that will be needed by FDA, 1,500 would be devoted to drug inspections. The beefed up drug staff would have the goal of inspecting firms "at least once every two years," the assessment says. "In domestic inspections, FDA's current staff is too small to inspect drug and device firms every two years, as required by law, and the entire inventory of firms is inspected on average only once every four years." FDA has 840 FTEs involved in good manufacturing practices inspections and bioresearch inspections. If FDA's resource needs are met, the assessment says, the agency could regain a balance between the size of industry and the size of FDA's compliance staff. During the 1980s, "the market value of industry's products (in constant dollars) increased by 20 percent, while the FDA work force intended to monitor these products declined by almost 30 percent," the analysis notes. FDA's goal in enforcement through 1997 is "to conduct systemic preapproval inspections and to restore adequate inspection coverage in every major product area, both imports and domestic." To improve FDA's surveillance of imports, the study suggests "stationing consumer safety officers in U.S. embassies could help FDA increase exporting countries' familiarity with FDA rules, and help to improve the quality of imports before they arrive in the U.S." The agency would like to have a total of 2,200 FTEs in the regulatory science area, including "400 positions to characterize and evaluate vaccines." In noting that FDA needs to "fill gaps in its knowledge of risk associated with all of its products," the assessment adds that "100 positions would be devoted to understanding risk associated with drug usage, in order to more solidly support drug review decisions." FDA also estimates that over "300 people are needed to develop an agency wide database to reduce scientific uncertainity in the risk assessment process; and to refine models for noncarcinogenic as well as carcinogenic risks." Another area that FDA wants to increase personnel is in field activities. "Almost 400 people are needed to upgrade the agency's field laboratory capability," the assessment says. "About 500 would be dedicated to improving and operating information management systems, and in particular, FDA's field information system." In a list of goals for the agency that reflects the recent agenda of Commissioner Kessler, the report cites the restoration and retention of the agency's credibility, and the reinforcement of "sound" management systems throughout FDA as priority aims. Other goals, reflected by the projected FTE allocations, include: increased enforcement authorities, reduced product review times especially for high priority products, strengthened risk assessments and testing methods, and improved labeling for consumers and health professionals.

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