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HEHS-96-53R 1 (1995-12-08)

handle is hein.gao/gaobaclab0001 and id is 1 raw text is: GAO United States General Accounting Office Washington, D.C. 20548 Health, Education and Human Services Division B-259939 December 8, 1995 The Honorable Nancy L. Kassebaum Chairman, Committee on Labor and Human Resources United States Senate Dear Madam Chairman: The Congress, industry groups, and others have raised concerns about delays in the Food and Drug Administration's (FDA) approval of new medical device, pharmaceutical, and biologic products. In the last 5 years, the Congress provided additional funding and staff positions to enable FDA to meet its existing mandates as well as new responsibilities under the Prescription Drug User Fee Act of 1992 and the Mammography Quality Standards Act of 1992. Since his appointment in December 1990, FDA's current Commissioner has made a number of organizational changes intended to improve agency performance. Critics of FDA have contended that the additional resources the Congress provided have been devoted to increasing staff in the Office of the Commissioner instead of increasing product approval staff. They also raised concerns that there has been an undue centralization of authority in the Office of the Commissioner. Because of these concerns, you asked us to develop information on several indicators of change in FDA's structure since the current Commissioner was appointed. Specifically, you asked us to describe (i) changes in the number of staff positions in the Office of the Commissioner, staff offices, and product centers; and (2) changes in decision- making authority of the Commissioner and the heads of FDA's principal operating units. To develop information on changes in the number of staff positions, we compared FDA's full-time equivalent (FTE) data from fiscal years 1990 and 1995.' To identify 'Before fiscal year 1992, FDA excluded FTEs associated with its stay-in-school program from the total FTE number. Therefore, the agency excluded 73 ceiling-exempt FTEs from GAO/SEES-96-53R Changes in FDA Structure

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