Food and Drug Administration Amendments Act of 2007

Food and Drug Administration Amendments Act of 2007

Long title	To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes.
Enacted by	the 110th United States Congress
Effective	September 27, 2007
Citations
Public law	110-85
Statutes at Large	121 Stat. 823
Codification
Acts amended	Federal Food, Drug and Cosmetic Act
Titles amended	21 U.S.C.: Food and Drugs
U.S.C. sections amended	301
Legislative history
Introduced in the House of Representatives as H.R. 3580 by John Dingell (D–MI) on September 19, 2007 Committee consideration by United States House Committee on Energy and Commerce Passed the House on September 19, 2007 (405-7) Passed the Senate on September 20, 2007 (Unanimous Consent) with amendment House agreed to Senate amendment on September 20, 2007 (cleared) with further amendment Senate agreed to House amendment on September 20, 2007 (cleared) Signed into law by President George W. Bush on September 27, 2007

President of the United States George W. Bush signed the Food and Drug Administration Amendments Act of 2007 (FDAAA), September 27, 2007. This law reviewed, expanded, and reaffirmed several existing pieces of legislation regulating the FDA. These changes allow the FDA to perform more comprehensive reviews of potential new drugs and devices.

The Prescription Drug User Fee Act (PDUFA) (IV) was first enacted in 1992 to allow the FDA to collect “user fees” from biotechnology and pharmaceutical companies. Since then, it has been reauthorized three times; first in 1997, then 2002, and most recently with the passage of the FDAAA in 2007.

The purpose of these fees is to provide resources to the FDA that help them more effectively review potential new drugs.The most recent reauthorization will further expand on the previous policy. It aims to broaden and upgrade the drug safety program, allocate more resources for television advertising, and theoretically allow the FDA to more efficiently review and approve safe and effective new drugs for consumers.

The FDAAA also requires registration and reporting of basic results of clinical trials of medicines and devices subject to FDA regulation on the freely-accessible site ClinicalTrials.gov.

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