H.R.6235 - FDA Scientific Fairness for Women Act109th Congress (2005-2006)
Summary: H.R.6235 — 109th Congress (2005-2006)
Introduced in House (09/28/2006)
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.