{
  "id": "RL34089",
  "type": "CRS Report",
  "typeId": "REPORTS",
  "number": "RL34089",
  "active": false,
  "source": "EveryCRSReport.com",
  "versions": [
    {
      "source": "EveryCRSReport.com",
      "id": 349349,
      "date": "2007-08-06",
      "retrieved": "2016-04-07T17:58:17.602029",
      "title": "FDA Legislation in the 110th Congress: A Guide to S. 1082 and H.R. 2900",
      "summary": "Both the House and the Senate have passed comprehensive legislation to reauthorize existing Food and Drug Administration (FDA) programs and expand the agency\u2019s authority to ensure the safety of prescription drugs, medical devices, and biologics. The Senate passed the Food and Drug Administration Revitalization Act (S. 1082) on May 9, 2007. The House passed the Food and Drug Administration Amendments Act of 2007 (H.R. 2900) on July 11, 2007.\nAt its core, the legislation renews authority for two key user fee programs that are 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). These account for 87% of FDA\u2019s user fee revenue, and 19% of FDA\u2019s total FY2008 program level budget. Without the reauthorizations, and absent a substantial increase in FDA\u2019s annual appropriations, the agency would lose a significant source of funding. FDA had warned that a failure to reauthorize the user fee programs before August 1, 2007, would require the agency to issue layoff notices, but the agency has reportedly forestalled that necessity by switching to reserve funds.\nIn addition to user fee programs, the bills reauthorize two other FDA authorities related to prescription drugs for pediatric populations, which are 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 on-patent and off-patent drugs. S. 1082 and H.R. 2900 also contain provisions related to drug safety, pediatric medical devices, clinical trial registration, and the creation of a new nonprofit entity to assist FDA with its mission. The bills\u2019 overlapping provisions are similar, but not identical.\nS. 1082 contains some additional provisions that are not present in H.R. 2900, on the topics of food safety, prescription drug importation, and domestic pet turtle market access. Attempts to expand the legislation to address several other FDA-related issues, for example, follow-on biologics and genetic testing, have thus far been unsuccessful. Differences between the bills may be addressed in conference.\nThis report contains background information about the FDA relevant to S. 1082 and H.R. 2900. It presents a comparative overview of the bills\u2019 contents, and contains links to pertinent CRS reports. This report will be updated as further legislative events warrant.",
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      "typeId": "REPORTS",
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      "topics": []
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  ],
  "topics": [
    "Appropriations",
    "Health Policy"
  ]
}