Bipartisan FDA Safety and Innovation Act signed by President Obama

WASHINGTON, D.C. (July 10, 2012) –President Obama signed into law the bipartisan Food and DrugAdministration (FDA) Safety and Innovation Act (FDASIA) on July 9. ThisAct reauthorizes FDA’s user fee program, which is critical to theAgency’s funding, and also includes a provision that has been longsought by the Society for Women’s Health Research (SWHR), the AmericanHeart Association (AHA) and Women Heart: The National Coalition forWomen with Heart Disease (WomenHeart) that will require FDA to provide a special report and accounting of trials by sex, race, and ethnicity.

The provision, section 907 of thelegislation, has been one of SWHR’s key advocacy efforts for over twodecades. It requires FDA to publicly report annually on the extent towhich clinical trial participation, safety, and efficacy data reportedby sex, age, race, and ethnicity are included in applications for FDAapproval of new drugs and medical devices. This language builds on aprovision of the HEART for Women Act, which has had bipartisan supportin Congress for years, and will help to close the knowledge gap, whichcontributes to substantial inequities in healthcare for women andminorities.

“Having this data appropriately analyzedand reported by FDA has been one of SWHR’s main priorities,” saidPhyllis Greenberger, president and CEO of SWHR. “As the leading voicefor women’s inclusion in clinical trials and the thought leader in sexdifferences research, we believe this is a critical first step infostering personalized medical decisions in the United States, whichwill ultimately lead to better patient care. We would like to thank thePresident for his support on this issue.”

Numerous studies have found thatsubgroup-specific data about how new drugs and devices perform in women, minorities, and older Americans consistently remain unavailable topatients and the medical community. Sex-specific research results can,and have, yielded important differences in the way drugs and deviceswork in women and men.

We want to thank President Obama and congressional leadership for their support of this provision.

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For more information on the Society for Women’s Health Research please contact Rachel Griffith at 202-496-5001 or Rachel@swhr.org .

The Society for Women’s Health Research (SWHR), a national non-profit organization based in Washington D.C., is widely recognized as the thought leader in women’s health research,particularly how sex differences impact health. SWHR’s mission is toimprove the health of all women through advocacy, education andresearch. Visit SWHR’s website at www.swhr.org for more information.