Food and Drug Administration Amendments Act of 2007

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Food and Drug Administration Amendments Act of 2007
Great Seal of the United States
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 (DMI) 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.[1]

Prescription Drug User Fee Act[edit]

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.[2]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.[3]

Medical Device User Fee and Modernization Act (MDUFMA)[edit]

  • Allows for user fees which will allow the FDA to make significant improvements in the medical device review program.
  • Establishment inspections may be conducted by accredited persons (third parties), and establish new regulatory requirements for reprocessed single-use devices. FDAAA changes the medical device establishment registration requirements, although both foreign and domestic drug manufacturers still must register establishments.

Best Pharmaceuticals for Children Act (BPCA)[edit]

  • Encourages more studies in children and promotes the development of treatments for children.
  • Intended to improve FDA and applicant accountability for the agreed-upon pediatric studies.
  • FDAAA broadens the definition of “pediatric studies” to include preclinical studies, and narrows the timeframe for sponsors to qualify for pediatric exclusivity.
  • The Pediatric Trials Network serves as the mechanism by which many studies on off-patent drugs are performed, in keeping with the BPCA objective of ensuring accurate drug labeling for children.

Pediatric Research Equity Act (PREA)[edit]

  • Continues FDA's authority to require studies in children concerning certain medical products and under other specific circumstances.

Priority review to encourage treatments for tropical diseases[edit]

Reagan-Udall foundation[edit]

  • To modernize product development, accelerate innovation, and enhance product food safety with clinical trial registries provisions by an advisory committee intended to enhance drug safety.
  • Also created to “modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.”

Advisory committee conflicts of interest[edit]

  • Continues the requirement that all individuals under consideration for appointment to serve on an FDA advisory committee disclose to the Agency all financial interests that would be affected by the committee’s actions.

Clinical trials reporting[edit]

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.[4]

See also[edit]

References[edit]

  1. ^ Law Strengthens FDA
  2. ^ BIO | The Prescription Drug User Fee Act (PDUFA)
  3. ^ Prescription Drug User Fees
  4. ^ PRS and U.S. Public Law 110-85

External links[edit]