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Food and Drug Administration: Selected Funding and Policy Issues (CRS Report for Congress)

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Release Date Feb. 27, 2001
Report Number RS20033
Report Type Report
Authors Donna U. Vogt, Domestic Social Policy Division
Source Agency Congressional Research Service
Summary:

The Food and Drug Administration (FDA) is responsible for ensuring the safety of foods, drugs, medical devices, cosmetics, and other products. The Food and Drug Administration Modernization Act of 1997 (FDAMA) [P.L.105-115], which amended the Federal Food, Drug, and Cosmetic Act (FFDCA), created many regulatory changes and reauthorized the Prescription Drug User Fee Act (PDUFA) through FY2002. The FY2001 Agriculture Appropriations Act increased FDAs appropriation by 4% over FY2000; some say, however, that given the increase in regulatory responsibilities, this funding is not enough for FDA to ensure the safety of the publics health. The appropriations act also contained a 5-year prescription drug import program that would allow pharmacists and wholesalers to import FDA-approved prescription drugs into the United States. The former Secretary of Health and Human Services refused to request money for the program unless the statutory language could be changed to eliminate certain flaws. Congress will also be facing requests to continue funding for the Food Safety Initiative. Most of its activities attempt to prevent the occurrence of foodborne illnesses. The 107th Congress will also be debating FDAs proposed rule on regulating bioengineered foods and its decision not to require the labeling of this food.