H.R. 4429 (109th): Food and Drug Administration Safety Act of 2005

Nov 18, 2005 (109th Congress, 2005–2006)
Died (Referred to Committee)
John Tierney
Representative for Massachusetts's 6th congressional district
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Last Updated
Nov 18, 2005
23 pages
Related Bills
H.R. 788 (110th) was a re-introduction of this bill in a later Congress.

Referred to Committee
Last Action: Jan 31, 2007

S. 930 (identical)

Referred to Committee
Last Action: Apr 27, 2005


This bill was introduced on November 18, 2005, in a previous session of Congress, but was not enacted.

Introduced Nov 18, 2005
Referred to Committee Nov 18, 2005
Full Title

To amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes.


No summaries available.

3 cosponsors (2D, 1R) (show)

House Energy and Commerce


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Primary Source

THOMAS.gov (The Library of Congress)

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H.R. stands for House of Representatives bill.

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The bill’s title was written by its sponsor.

GovTrack’s Bill Summary

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Library of Congress Summary

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress.

Food and Drug Administration Safety Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Drug Evaluation and Research within the Food and Drug Administration (FDA).
Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by:
(1) conducting postmarket risk assessment and surveillance of such drugs and products;
(2) determining whether a postmarket study is required;
(3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international surveillance databases to conduct epidemiologic and other observational studies;
(4) determining whether a drug or product may present an unreasonable risk to the health of patients or the general public;
(5) taking corrective action if such an unreasonable risk may exist; and
(6) making information about the safety and effectiveness of such drugs and biological products available to the public and health care providers in a timely manner.
Requires the Drug Safety and Risk Management Drug Advisory Committee to make recommendations to the Director on postmarket studies, drugs and biological products that may present an unreasonable risk, and appropriate corrective actions.
Allows the Secretary of Health and Human Services to assess civil penalties for violations of this Act.
Allows the Director to withdraw or suspend approval of a drug or license for a biological product using expedited procedures under certain circumstances.
Transfers to the Center the functions and duties of the Office of Drug Safety.

House Republican Conference Summary

The summary below was written by the House Republican Conference, which is the caucus of Republicans in the House of Representatives.

No summary available.

House Democratic Caucus Summary

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