DeLauro Legislation Prioritizes Women’s Health at FDA

Washington , D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) in an effort to ensure science – not ideology – informs decisions within the Food and Drug Administrations (FDA), reintroduced legislation that would make women’s health issues a priority at the agency.  In the past year, there have been several instances in which the FDA appears to have dismissed scientific evidence in making its determinations – from the application for the Plan B emergency contraception to the approval of silicone breast implants despite ongoing safety concerns. 

“When the FDA reviews drug and medical device applications, the American people expect the FDA to be objective and independent; making decisions based on science, not on corporate and political considerations.  Unfortunately, recent actions suggest that no one has more at stake in de-politicizing FDA decisions and restoring integrity to the agency than women, which is why we need to prioritize women’s health at the agency and ensure scientists are able to work unfettered.”

The FDA Scientific Fairness for Women Act – endorsed by the National Research Center for Women and Families, Breast Cancer Fund, National Women’s Health Network, NOW, Reproductive Technologies Project, Our Bodies Ourselves, In the Know and Command Trust Network – would take politics out of women’s health decision-making at FDA by: 

·       Rescinding the approval of silicone breast implants if the safety has not been conclusively demonstrated for the life of the implant;

·       Requiring FDA to convene a workshop to review and evaluate current scientific data on the use of emergency contraception by young women under the age of 18; and

·       Elevating the Office of Women's Health within the FDA so that the office reports directly to the Commissioner.

Last November, the FDA approved the use of silicone breast implants even though many experts questioned whether the manufacturers provided the necessary data to demonstrate the safety of the devices.  In approving silicone breast implants, the FDA required the manufacturers to conduct post-approval studies that would help monitor the safety of the device once implanted.  However, it appears that one of the manufacturers already has persuaded the FDA to create a loophole by removing a mandatory requirement from its post-market study.

Earlier this year, the FDA had considered cutting funds to the Office of Women’s Health and had to be persuaded to simply maintain the funding level that was requested by the administration and provided by Congress.  Now that the FDA Office of Women’s Health has achieved a modicum of financial fairness, it is time for scientific fairness as well.

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www.house.gov/delauro