	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. They warn that the agency is at risk of being unable to adequately fulfill the many statutory responsibilities that Congress has assigned it. In general, former FDA Commissioners and interest groups argue that FDA is underfunded for its mission. Calls for cutting the FDA budget or maintaining it at the current level come from organizations, like CATO and the Hoover Institute, that propose limitations on FDA's authority and, therefore, the need for funding. The main voices in support of FDA budget levels, past and present, have been representatives of the various presidential administrations. This report examines FDA's appropriations history and traces the evolution of the agency's statutory responsibilities. The information is presented to help inform the ongoing discussion about FDA. The report first provides an overview of FDA's budget and personnel levels from FY1980 through FY2007. That is followed by a more detailed examination of the budget and personnel level over the same period in each of the agency's major activity areas. Agency Scope and Congressional Jurisdiction

FDA regulates a wide range of products valued at more than $1 trillion in the U.S. economy. As one of the agencies within HHS that comprise the Public Health Service, FDA is responsible for the safety of most foods (human and animal) and cosmetics. FDA also regulates both the safety and the effectiveness of human drugs, biologics (e.g., vaccines), medical devices, and animal drugs. Another indicator of agency resources is personnel, available in the Justification documents as the number of full-time equivalent employees (FTEs). For FDA as a whole, comparing FY2006, the most recent year for which we have parallel data sources for both dollars and FTEs, to FY1980 yields these inflation-adjusted findings (see Figure 1 ):
FDA Budget:
almost a doubling of direct congressional appropriations (budget authority); more than an 10-fold increase in other funds, mostly user fees; resulting in an overall budget in FY2006 almost 2-1/2 times that in FY1980. FDA FTEs:
less than a 1% increase in budget authority-funded FTEs; an almost fourfold increase in FTEs funded by other sources, mostly user fees; resulting in an overall 19% increase from FY1980 to FY2006. The budget authority funded FTEs decreased by 14%, but the overall human drug FTE level increased by 40% because of user fee funding. Activity Area Budgets
This report follows the order in the FY2008 Justification document in presenting information on FDA's five major activity areas: Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Medical Devices and Radiological Health.
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.