The Food and Drug Administration: Budget and Statutory History, FY1980-FY2007 (CRS Report for Congress)
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| Release Date |
Jan. 29, 2008 |
| Report Number |
RL34334 |
| Report Type |
Report |
| Authors |
Judith A. Johnson, Donna V. Porter, Susan Thaul, and Erin D. Williams, Domestic Social Policy Division |
| Source Agency |
Congressional Research Service |
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.
