[20010227]RS20033_美国食品和药物管理局：选定的资金和政策问题.pdf

1 Federal Food, Drug, and Cosmetic Act of 1938 (FFDCA), as amended, (21 U.S.C. 301 et seq.)gives FDA its broad regulatory and enforcement authority. In 1968 FDA became part of thePublic Health Service (PHS) within the Department of Health, Education and Welfare. In 1988the FFDCA was amended by the Food and Drug Administration Act, Title V of the Health(continued.)Congressional Research Service The Library of CongressCRS Report for CongressReceived through the CRS WebOrder Code RS20033Updated February 27, 2001Food and Drug Administration: Selected Funding and Policy IssuesDonna U. VogtDomestic Social Policy DivisionSummaryThe Food and Drug Administration (FDA) is responsible for ensuring the safety offoods, drugs, medical devices, cosmetics, and other products. The Food and DrugAdministration Modernization Act of 1997 (FDAMA) P.L.105-115, which amendedthe Federal Food, Drug, and Cosmetic Act (FFDCA), created many regulatory changesand reauthorized the Prescription Drug User Fee Act (PDUFA) through FY2002. TheFY2001 Agriculture Appropriations Act increased FDAs appropriation by 4% overFY2000; some say, however, that given the increase in regulatory responsibilities, thisfunding is no