FDA Amendments Act of 2007 (P.L. 110-85) (RL34465) / Erin D. Williams, Susan Thaul.

Format:

Book

Author/Creator:

Williams, Erin D., author.

Thaul, Susan, author.

Contributor:

Library of Congress. Congressional Research Service, issuing body.

Series:

Report / Congressional Research Service ; RL34465

Language:

English

Subjects (All):

United States. Food and Drug Administration.

United States.

Food law and legislation.

Physical Description:

1 online resource (95 pages)

Updated irregularly

Edition:

[Library of Congress public edition].

Place of Publication:

Washington, D.C. : Congressional Research Service, 2008.

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'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.

Notes:

The CRS report home page provides access to all versions published since 2018 in accordance with P.L. 115-141; earliest version dated 2010.

Report includes bibliographical references.

Description based on online resource; title from PDF title page (Congressional Research Service, viewed June 9, 2023).

OCLC:

1137386034