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HR 6235 109th Congress House Health Child health Commerce Conflict of interests Congressional reporting requirements Consumer education Contraceptives Department of Health and Human Services Drugs Executive reorganization Families Federal advisory bodies Finance and Financial Sector Food and Drug Administration (FDA) Government Operations and Politics Government employees' health insurance Government publicity Labeling Medical ethics Medical research

FDA Scientific Fairness for Women Act

Introduced: September 28, 2006 Introduced by: DeLauro, Rosa L. Democratic · Connecticut See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Oct 2, 2006
Referred to the Subcommittee on Health.
Sep 28, 2006
Referred to the House Committee on Energy and Commerce.
Sep 28, 2006
Introduced in House
 Plain-English summary Congressional Research Service

FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA).

Prohibits the Secretary of Health and Human Services from finding that a reasonable assurance of safety has been shown for an application for premarket approval for a class III device for a breast implant unless the applicant involved has established the lifetime of the implant and demonstrates that safety has been demonstrated for the life of the implant. Requires the Secretary to determine appropriate clinical care and removal and replacement requirements for the implant, including appropriate coverage by government health care systems.

Sets forth provisions governing any FDA advisory committee that considers issues concerning breast implants, including that the Secretary may not grant any exemption for conflicts related to personal financial interests.

Requires the Secretary to: (1) provide for a study on the ionization and levels of platinum in silicone breast implants; and (2) establish a panel of independent scientists for the purpose of designing and conducting the study.

Requires the Secretary, acting through the Commissioner of Food and Drugs, to convene a scientific workshop to review and evaluate current scientific data on the use of emergency contraception by females of childbearing potential under the age of 18, including scientific questions identified in the recent limited approval of Plan B emergency contraception.

What's happening now October 2, 2006

Referred to the Subcommittee on Health.

 Committees of jurisdiction 2