S. 468 (110th): Food and Drug Administration Safety Act of 2007

Introduced:
Jan 31, 2007 (110th Congress, 2007–2009)
Sponsor:
Sen. Charles “Chuck” Grassley [R-IA]
Status:
Died (Referred to Committee)

The bill’s title was written by the bill’s sponsor. S. stands for Senate bill.

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Status

This bill was introduced on January 31, 2007, in a previous session of Congress, but was not enacted.

Progress
Introduced Jan 31, 2007
Referred to Committee Jan 31, 2007
Cosponsors
4 cosponsors (4D) (show)
Committees

Senate Health, Education, Labor, and Pensions

The committee chair determines whether a bill will move past the committee stage.

Full Title

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

Summary

No summaries available.

Text

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Last updated Jan 31, 2007.
24 pages

Primary Source

View on THOMAS (The Library of Congress)

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Citation

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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.

1/31/2007--Introduced.
Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics 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 patient 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 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 Surveillance and Epidemiology.

House Republican Conference Summary

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No summary available.

House Democratic Caucus Summary

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The bill contains the following citations to other parts of U.S. law:

United States Code

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