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, let alone to position itself for an increasingly challenging future.... There is little dispute that FDA in general is ... severely underfunded. Several individuals who previously held high-ranking positions in FDA or the Department of Health and Human Services (HHS) have organized advocacy groups to lobby for increased funding for the entire agency. These groups present data to support their position that FDA has fallen behind in overall funding in the last 25 years. They warn that the agency is at risk of being unable to adequately fulfill the many statutory responsibilities that Congress has assigned it. While the call for more resources has been heard from many quarters, including some in Congress, some agency critics are concerned about inefficiencies within FDA and that it needs to do a better job managing what resources it does have. 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. Over the last 25 years, incumbent FDA Commissioners, when asked during congressional hearings about the adequacy of the FDA budget, have testified that the budget is sufficient to accomplish the job before the agency. However, in non-congressional venues, those same Commissioners have expressed concerns about the constraints on FDA resources and that the agency's core budget has not increased in concert with its rising responsibilities. They have expressed concern about whether the agency can continue to be considered the world's premier consumer protection agency when it is forced to focus its priorities based on the current level of resources that it receives. 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. CRS takes no position on whether the agency has the necessary resources to meet its statutory responsibilities. 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. For each activity area, the report also summarizes the major pieces of legislation that have been enacted since FY1980. Unless noted otherwise, all budget data have been adjusted for inflation to permit comparison across the 28-year period under investigation. The information presented in this report is intended to facilitate an examination of the impact that administrations' budget requests and congressional decision making have had on the ability of FDA to accomplish its public health mission. FDA regulates a wide range of products valued at more than $1 trillion in the U.S. economy. About 25% of American consumer dollars are spent on these FDA-regulated products. 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. The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, is the principal source of FDA's authority. The agency also derives some of its authority from certain provisions in other laws, most notably the Public Health Service (PHS) Act. Under the PHS Act, FDA licenses biological products and performs other activities, such as setting standards for mammography quality. An extensive list of the public laws that significantly affect FDA activities is in Table A-4 in the Appendix . In addition to statutory responsibilities that directly involve product regulation, the FDA must also comply with statutory requirements affecting all or most federal executive agencies, regarding such matters as information management, strategic planning, performance measurement, financial management, property management, and human resources management. Additional requirements apply only to those agencies, including FDA, that have regulatory responsibilities. FDA's role in implementing provisions of some general federal management laws is substantial. For example, the agency supports more than 50 advisory committees, most of which are mandated in statute and are subject to requirements of the Federal Advisory Committee Act. Also, the agency reports that in FY2006 it processed more than 20,000 information requests pursuant to requirements of the Freedom of Information Act. The congressional authorizing committees that oversee FDA activities are those with jurisdiction over public health issues: the Senate Committee on Health, Education, Labor, and Pensions, and the House Committee on Energy and Commerce. Because Medicare pays for FDA-regulated products, the agency also falls under the jurisdiction of the Senate Committee on Finance and the House Committee on Ways and Means. Other committees that exercise oversight roles regarding FDA include the House Committee on Oversight and Government Reform, and the Senate Committees on Aging, Homeland Security and Governmental Affairs, and the Judiciary. The House and Senate Appropriations subcommittees on agriculture have jurisdiction over FDA's appropriations. This arrangement reflects, in part, the agency's origin within the Department of Agriculture as the Bureau of Chemistry in 1862. Since 1940, FDA has administratively been part of federal health agencies, specifically HHS and its predecessors. Advocates for increasing FDA funding point to this jurisdictional separation of FDA appropriations decisions from the rest of PHS and HHS as a contributing factor to what they see as underfunding. In 2002, former Acting FDA Commissioner Michael Friedman recommended moving the FDA budget process from the purview of the agriculture appropriations subcommittees to the Labor, Health and Human Services, Education and Related Agencies subcommittees. Five years later, former FDA Commissioner Frank Young raised the same concern and made the same recommendation in congressional testimony. Former FDA Commissioner Jane Henney made a similar observation in February 2007: [T]here are other things Congress can do that directly impact this agency's resources ... if they really wanted to look long and hard, FDA would no longer be under the purview of the Agriculture Appropriations Committees. Those people that serve on those committees do it with honor, but they do it primarily because of their interest in agricultural issues. By the time the allocations come out and the interest of the agriculture areas are satisfied, there are very limited resources that the agency [FDA] can ever hope to receive out of that process. If somebody wanted to do something bold ... it would be looking at appropriations in an area that is more compatible ... with the interests of the members of that committee particularly the ones that oversee health issues. The primary indicator of FDA resources is its budget. The agency's FY2007 total budget is approximately $2 billion. The total FDA budget, also called the program level , consists of (1) direct appropriations and (2) other funds (i.e., funding from other sources that are acknowledged in the appropriations acts). Direct appropriations are the amount of funds that Congress assigns to the agency from the annual total available for appropriations as set by the budget committees. Other funds include reimbursables, cooperative research and development agreement (CRADA) resources, intra- and inter-agency services (such as the Parklawn Computer Center), mammography fees, color certification fees, export certification fees, prescription drug user fees, medical device user fees, and animal drug user fees. FDA annually prepares budget data for Congress that it presents in the Justification of Estimates for Appropriations Committees ( Justification ) documents. FDA transmits its draft through HHS to the White House Office of Management and Budget (OMB). The final Justification documents, reflecting any HHS and OMB adjustments, are published with the President's annual budget request to Congress. The final Justifications are the major source of FDA budget figures and tables in this report. Like most federal agencies, FDA has, over time, reorganized its structure, activities, and budget accounting, which makes historical budget analysis a difficult endeavor. For further information on the difficulties in compiling a budget history of the agency, and the steps taken to address those problems for this report, see the Methodology section in the Appendix . Until FY1992, direct appropriations formed over 95% of FDA's total program level, with other funds contributing the small remainder. A shift began in FY1992 when Congress authorized: (1) the assessment and collection of user fees from pharmaceutical manufacturers for the review of human drug and biologics applications, and (2) fees for the inspection of mammography facilities. Congress subsequently authorized the collection of user fees for the review of medical device applications in FY2002 and animal drug applications in FY2004. By FY2007, other funds, primarily user fees, accounted for almost a quarter of FDA's total program level budget. Another indicator of agency resources is personnel, available in the Justification documents as the number of full-time equivalent employees (FTEs). This is, however, an imperfect measure of personnel strength because it is not weighted by type of position, pay grade, or responsibility, each of which would provide a different measure of the agency's human resources. FDA has described how adjusting salaries for standard measures of inflation is inadequate because of the unique elements of its staff expenses, such as higher than average employee salaries, cost of health and retirement benefits, and resources required for recruitment and retention.