{
  "id": "RL34465",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL34465",
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      "id": 412152,
      "date": "2010-04-27",
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      "title": "FDA Amendments Act of 2007 (P.L. 110-85)",
      "summary": "On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA; H.R. 3580) was signed into law (P.L. 110-85). The comprehensive law reauthorizes four expiring Food and Drug Administration (FDA) programs and expands the agency\u2019s authority to regulate the safety of prescription drugs and biologics, medical devices, and foods. Understanding the way in which FDAAA changed the law governing the agency informs policy discussions aimed at additional FDA reform and reorganization, as well as those related more broadly to the quality, availability, and cost of medical products in the health care system.\nAt its core, FDAAA renews the authority for two key user fee programs that were set to expire on October 1, 2007: the Prescription Drug User Fee Act (PDUFA; P.L. 107-188) and the Medical Device User Fee and Modernization Act (MDUFMA; P.L. 107-250). In FY2007, the year in which FDAAA was enacted, these programs accounted for 91% of FDA\u2019s user fee revenue and 18% of FDA\u2019s total budget. Without the reauthorizations, and absent a substantial increase in FDA\u2019s annual appropriations, the agency would have lost a significant amount of funding.\nIn addition to user fee programs, FDAAA reauthorizes two other FDA authorities related to prescription drugs for pediatric populations, which were also due to expire on October 1, 2007: the Best Pharmaceuticals for Children Act (BPCA; P.L. 107-109) and the Pediatric Research Equity Act (PREA; P.L. 108-155). These laws provide marketing exclusivity incentives and requirements for studying pediatric use of drugs. FDAAA also contains provisions related to drug safety, pediatric medical devices, clinical trial databases, the creation of a new nonprofit entity to assist FDA with its mission, and food safety.\nThis report presents a detailed summary of provisions in FDAAA. Each section of the report begins with background information about the FDA relevant to the passage of FDAAA and some references, if appropriate, to the two bills that formed its basis (S. 1082 and H.R. 2900), and a law that amended it (P.L. 110-316); describes FDAAA\u2019s contents; and analyzes how FDAAA changed the law. The report also contains links to pertinent CRS reports. This report, which is intended for reference use, will not be updated other than to reflect any technical changes that Congress might enact.",
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    },
    {
      "source": "University of North Texas Libraries Government Documents Department",
      "sourceLink": "https://digital.library.unt.edu/ark:/67531/metadc809479/",
      "id": "RL34465_2008Apr28",
      "date": "2008-04-28",
      "retrieved": "2016-03-19T13:57:26",
      "title": "FDA Amendments Act of 2007 (P.L. 110-85)",
      "summary": null,
      "type": "CRS Report",
      "typeId": "REPORT",
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  ],
  "topics": [
    "Appropriations",
    "Domestic Social Policy",
    "Health Policy"
  ]
}