FDA Scientific Fairness for Women Act

Summary

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.

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Timeline

1. 28 September 2006

   Introduced

   Referred to the House Committee on Energy and Commerce.

   Source: IntroReferral

2. 28 September 2006

   Introduced

   Introduced in House

   Source: IntroReferral

3. 28 September 2006

   Introduced

   Introduced in House

   Source: IntroReferral

4. 2 October 2006

   Referred

   Referred to the Subcommittee on Health.

   Source: Committee

Votes

No vote records are attached yet.

Versions

• Introduced in House · 28 September 2006 · Official file

Documents

3 official files

• Introduced in House (text)

  Introduced in House · EN · 28 September 2006

  ViewDownloadOpen at official source

• Introduced in House (PDF)

  Introduced in House · EN · 28 September 2006

  ViewDownloadOpen at official source

• Introduced in House

  summary · EN · 28 September 2006

  Open at official source

Sponsors

• Rosa DeLauro · D · Sponsor
• Rep. Hinchey, Maurice D. [D-NY-22] · D · Sponsor
• JOHN CONYERS · D · Sponsor
• Sheila Jackson Lee · D · Sponsor
• SUSAN DAVIS · D · Sponsor
• Rep. Solis, Hilda L. [D-CA-32] · D · Sponsor
• Rep. McDermott, Jim [D-WA-7] · D · Sponsor
• Linda Sánchez · D · Sponsor
• Rep. Stark, Fortney Pete [D-CA-9] · D · Sponsor
• Rep. Moran, James P. [D-VA-8] · D · Sponsor
• Raúl Grijalva · D · Sponsor
• Rep. Capps, Lois [D-CA-24] · D · Sponsor
• CAROLYN MALONEY · D · Cosponsor
• Rep. Frank, Barney [D-MA-4] · D · Cosponsor
• Rep. Schakowsky, Janice D. [D-IL-9] · D · Cosponsor
• Rep. Wexler, Robert [D-FL-19] · D · Cosponsor
• Rep. Boucher, Rick [D-VA-9] · D · Cosponsor
• · hsif00 · Standing

Related records

No cross-record relationships stored yet.