H.R. 2090: Food and Drug Administration Improvement Act of 2005

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H.R. 2090: Food and Drug Administration Improvement Act of 2005

109th Congress · introduced 2005-05-04 · Health · Latest: Sponsor introductory remarks on measure. (CR H4358-4359)

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Official title

Food and Drug Administration Improvement Act of 2005

Plain summary

Food and Drug Administration Improvement Act of 2005 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to: (1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug. Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies. Requires the Secretary to follow the interpretation that the FDA used in 1999 that the FFDCA and Public Health Service Act establish minimal standards but do not preclude additional state requirements. Requires the Secretary to cease intervening in product liability civil actions to argue another interpretation. Sets forth procedures for advisory committee meetings to ensure that the committee is fairly balanced. Prohibits any exemptions from being granted to advisory committee members from rules prohibiting members from having a personal financial interest in the outcome. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

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PSI Sci description of the legislative step (not an opinion).

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Alternatives

Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.

How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Hinchey, Maurice D. [D-NY-22] · 15 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Rosa L. DeLauro (D-CT), Ed Case (D-HI), Stephen F. Lynch (D-MA), Bernard Sanders (I-VT), James P. McGovern (D-MA)

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Sources

• Congressional Research Service summary (Introduced in House)
• Congress.gov
• Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-109hr2090.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/109/hr>

Record fed-us-cong109-hr2090 · catalog fed-us-congress-bills-cong109 · updated 2026-11-15 by psicol fed-bills-cong109