DeLauro, Scientist Advocates Concerned About Recent

FDA Decisions Release Reform Legislation for Women

FDA Scientific Fairness for Women Act Elevates Women’s Issues,

Ensures Science – Not Ideology – Informing Decisions on Women’s Health 

WASHINGTON , D.C. – Congresswoman Rosa L. DeLauro (Conn.-3) today joined scientist advocates to release FDA reform legislation aimed at ensuring science, not ideology informs decisions within the agency in three main areas of women’s health: the Office of Women’s Health, the issue of silicone breast implants, and Plan B.  Susan F. Wood, Ph. D, research professor, George Washington University, School of Public Health and Health Services, the former assistant FDA commissioner for women's health and former director of the FDA Office of Women's Health as well as Diana Zuckerman, Ph. D and president of the National Research Center for Women and Families joined DeLauro to unveil the legislation.

“Every American needs the FDA to make its decisions on the basis of science not politics, when reviewing drug and medical device applications.  But recent events suggest that no one has more at stake in taking politics out of FDA decision-making and restoring integrity to the agency than women,” said DeLauro.  “My goal is to let hard-working and diligent scientists already at FDA do their work without any political or corporate interference.”

Among the highlights of The FDA Scientific Fairness for Women Act:

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

·         Requires manufacturers to demonstrate the safety of breast implants prior to the approval of their applications; and

·         Requires the 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

“This legislation addresses critical concerns about science driving the decisions at FDA, particularly when these decisions affect women’s health,” said Susan Wood.  “Congress has the important role of oversight to ensure that FDA is a strong and effective agency protecting the health of all, and Rep. DeLauro’s bill does that.”

“Rep. DeLauro’s legislation puts the focus where it belongs: on science and on women’s health,” said Diana Zuckerman.  “Women deserve medical products that have been scientifically proven to be safe and effective, and neither industry pressure nor political ideology should undermine the scientific findings.  That’s true for Plan B, silicone implants, and every medical product that FDA reviews.”

DeLauro is the ranking member of the House Appropriations Agriculture Subcommittee, with jurisdiction and oversight responsibilities of the FDA and its budget.

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www.house.gov/delauro