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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007

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The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 -name redacted-, Coordinator Specialist in Biomedical Policy -name redacted- Specialist in Nutrition and Food Safety -name redacted- Specialist in Drug Safety and Effectiveness -name redacted- Specialist in Public Health and Bioethics January 29, 2008 Congressional Research Service 7-.... www.crs.gov RL34334 CRS Report for Congress Prepared for Members and Committees of Congress The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 Summary Considerable attention has been focused on the ability of the Food and Drug Administration (FDA) to accomplish its mission with the funds provided by congressional appropriations and user fees. FDA regulates a wide range of products valued at more than $1 trillion in the U.S. economy. The agency plays a key public health role. FDA is responsible for the safety of most foods (human and animal) and cosmetics, and it regulates both the safety and the effectiveness of human drugs, biologics (e.g., vaccines), medical devices, and animal drugs. In congressional hearing testimony and at other public venues, former FDA Commissioners, interest group representatives, and former high-ranking individuals in the agency or in the Department of Health and Human Services have argued that FDA is underfunded and at risk of being unable to fulfill all the statutory responsibilities assigned by Congress. Reports by the Institute of Medicine, the Government Accountability Office, and the FDA Science Board have made similar observations. The main voices in support of FDA budget levels, past and present, have been representatives of the various presidential administrations. Calls for cutting the FDA budget or maintaining it at the current level come from organizations, such as CATO and the Hoover Institute, that propose limitations on the agency’s authority and, therefore, its need for funding. Some agency critics have expressed concerns about inefficiencies within FDA and its ability to manage its resources. In order to inform the ongoing discussion about FDA, this report presents FDA’s appropriations history and traces the evolution of the agency’s statutory responsibility. It first provides a 28-year budget history for the agency along with personnel levels as shown by the number of full-time equivalent employees (FTEs). This report found that direct congressional inflation-adjusted appropriations (budget authority) to FDA doubled, and that the contribution of other funds, mostly user fees, increased more than 12-fold, resulting in an overall budget in FY2007 almost 2½ times that in FY1980. Between FY1980 and FY2006, the latest year with final FTE data, the agency’s FTE level increased 19% overall, from a less than 1% increase in budget authority- funded FTEs and an almost fourfold increase in FTEs funded by other sources (mostly user fees). The report also provides a more detailed examination of the budget and personnel levels for each of FDA’s major activity areas: Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Devices and Radiological Health. Findings include the relationship of user fees to budget authority, declining funding of research, and summaries of the major laws enacted since FY1980. Congressional Research Service The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 Contents Introduction ................................................................................................................................1 Agency Scope and Congressional Jurisdiction.............................................................................2 FDA Budget and Personnel .........................................................................................................4 Overall FDA Budget .............................................................................................................4 Comparison of FDA Budget with Other Agency Budgets ......................................................7 FDA Activity-Area Budgets ................................................................................................12 Impact of New Statutory Authorities on FDA Budget ..........................................................14 FDA Regulatory Research...................................................................................................15 FDA Science Board Report .................................................................................................17 Major Activity Areas: Budget and FTEs....................................................................................19 Foods..................................................................................................................................19 Human Drugs......................................................................................................................23 Biologics ............................................................................................................................27 Animal Drugs and Feeds .....................................................................................................30 Devices and Radiological Health.........................................................................................34 Other Activities and Responsibilities ...................................................................................37 Toxicological Research .................................................................................................37 Headquarters and Office of the Commissioner...............................................................38 Field Activities: The Office of Regulatory Affairs..........................................................38 Concluding Comments..............................................................................................................38 Figures Figure 1. FDA: Budget and FTEs................................................................................................6 Figure 2. Budget Authority for FDA, CDC, and NIH...................................................................8 Figure 3. FDA Budgets for FY1980 and FY2006, by Major Activity Area and Type of Funding .................................................................................................................................14 Figure 4. FDA Research in Five Activity Areas (Constant FY2000 $)........................................16 Figure 5. Foods: Budget and FTEs(Constant FY2000 $)............................................................23 Figure 6. Human Drugs: Budget and FTEs (Constant FY2000 $)...............................................24 Figure 7. Biologics: Budget and FTEs (Constant FY2000 $)......................................................29 Figure 8. Animal Drugs and Feeds: Budget and FTEs(Constant FY2000 $) ...............................32 Figure 9. Devices and Radiological Health: Budget and FTEs (Constant FY2000 $)..................36 Tables Table 1. Summary of Increase in Total Budget and FTEs, FY1980 and FY2006 (Constant FY2000 $) .............................................................................................................................13 Table 2. Foods Statutory Authorities in 1980 and 2007 ..............................................................21 Table 3. Human Drugs Statutory Authorities in 1980 and 2007..................................................26 Congressional Research Service The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 Table 4. Biologics Statutory Authorities in 1980 and 2007.........................................................30 Table 5. Animal Drugs and Feeds Statutory Authorities in 1980 and 2007.................................33 Table 6. Devices and Radiological Health Statutory Authorities in 1980 and 2007 .....................37 Table A-1. Actions Taken to Address FDA Budget Data Limitations..........................................44 Table A-2. FDA Appropriations, Overall and by Major Program, Budget Authority and Other Funding, FY1980 through FY2008, Unadjusted for Inflation ........................................46 Table A-3. Full-time Equivalents, Overall and by Major Program, Budget Authority- Funded and Other-Funded, FY1980 through FY2008 .............................................................48 Table A-4. Selected Public Laws Since 1848 Significantly Affecting FDA Activities .................50 Appendixes Appendix. Methodology............................................................................................................42 Contacts Author Contact Information ......................................................................................................57 Congressional Research Service The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 Introduction There is growing debate about whether the Food and Drug Administration (FDA) has the ability to accomplish its mission with the resources provided by congressional appropriations and industry user fees. FDA plays a central role in protecting the public health in the United States by regulating most of the food supply and vitally important medical products, including drugs, devices, and biologics that affect American lives on a daily basis. A 2006 report on drug safety by the Institute of Medicine (IOM) made the following observation in a chapter devoted to FDA resources: The Food and Drug Administration lacks the resources needed to accomplish its large and complex mission today,
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