FDA Amendments Act of 2007 (P.L. 110-85)

Erin D. Williams
Specialist in Public Health and Bioethics

Susan Thaul
Specialist in Drug Safety and Effectiveness

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. .


Date of Report: April 27, 2010
Number of Pages: 100
Order Number: RL34465
Price: $29.95

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