110-85 ) was signed into law on September 27, 2007. The law reauthorizes four expiring Food and Drug Administration (FDA) programs and expands the agency's authority to ensure the safety of prescription drugs and biologics, medical devices, and foods. The primary impetus for the legislation was the renewal of FDA's authority for two key user fee programs that were set to expire at the end of FY2007: the Prescription Drug User Fee Act (PDUFA, last reauthorized in 2002; P.L. 107-188 ), and the Medical Device User Fee and Modernization Act (MDUFMA, enacted in 2002; P.L. The law also reauthorizes two other expiring authorities, which are related to pediatric pharmaceuticals: the Best Pharmaceuticals for Children Act (BPCA, last reauthorized in 2002; P.L. 107-109 ), and the Pediatric Research Equity Act (PREA, enacted in 2002; P.L. 108-155 ). In addition to the reauthorizations, FDAAA contains several other FDA-related provisions. These include provisions designed to enhance drug safety, spark the development of pediatric medical devices, expand the types of trials and the substance of information in clinical trial databases, create a new nonprofit entity to assist FDA with its mission, improve food safety, and affect a number of other areas related to public health. In performing that role, as refined by FDAAA, FDA's regulation of medical products affects their quality, availability, and cost within the health care system. Legislative Background: S. 1082 and H.R. These were the Food and Drug Administration Revitalization Act ( S. 1082 ), and the Food and Drug Administration Amendments Act of 2007 ( H.R. Each section introduces the topic, surveys the ways in which new provisions changed the law, provides links to relevant CRS reports, and presents a detailed table comparing FDAAA-enacted provisions to any existing previous law. Prescription Drug User Fee Amendments of 2007

Title I of FDAAA, the Prescription Drug User Fee Amendments of 2007 (referred to as PDUFA IV), provides a five-year extension of FDA's authority to collect user fees from manufacturers of drug and biological products and expands the authorized uses of fee revenue. Reauthorization and Report Requirements. 107-250 ). FDA's authority to collect medical device user fees was due to expire on October 1, 2007. MDUFA 2007 became effective on October 1, 2007. P.L.
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's 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.
At 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's user fee revenue and 18% of FDA's total budget. Without the reauthorizations, and absent a substantial increase in FDA's annual appropriations, the agency would have lost a significant amount of funding.
In 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.
This 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's 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.