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SWHR Applauds Congressional Leaders for Letters Urging Federal Agencies to Re-Examine the Inclusion of Women in Clinical Trials

SWHR® Advised of House and Senate Letters Sent Today to the GAO and the FDA

Washington, D.C. – The Society for Women’s Health Research (SWHR®) is the leading voice on research into the biological differences between women and men. SWHR President and CEO Phyllis Greenberger comments on the letters sent today by Senators and Representatives to the Government Accountability Office (GAO) and Food and Drug Administration (FDA):

“For nearly 25 years, the Society for Women’s Health Research has been the leading advocate for more research into biological sex differences in health and medicine. We are pleased to see renewed congressional inquiry into the underrepresentation of women and minorities in clinical trials. I would like to thank the Members of Congress who signed onto these letters. They are an important reminder that while much progress has been made, much more still needs to be done.

The letter to the GAO, sent by Representative Henry A. Waxman, Senator Tom Harkin, Representative Frank Pallone, Jr., Senator Barbara Mikulski, Representative Nita Lowey, Senator Elizabeth Warren, Representative Rosa L. DeLauro, Senator Kirsten Gillibrand, Representative Lois Capps, and Senator Debbie Stabenow, requested a re-examination of women’s inclusion in NIH-sponsored clinical trials. SWHR led the fight for passage of the National Institutes of Health Revitalization Act in 1993, which required the inclusion of women and minorities in all NIH-supported clinical trials. Even with the passage of that landmark legislation, women are still underrepresented in the early phases of research. We thank these Congressional leaders for their vigilance and join them in urging the GAO to examine where we stand after more than 20 years after the passage of that historic legislation.

The letter to the FDA, sent by Senators Debbie Stabenow, Susan Collins, Barbara Mikulski, Heidi Heitkamp, Kelly Ayotte, Patty Murray, Jeanne Shaheen, Kay Hagan, Mazie Hirono, Dianne Feinstein, Elizabeth Warren, Barbara Boxer, Tammy Baldwin, Kirsten Gillibrand, and Lisa Murkowski, calls for greater analysis of sex differences in the evaluation of new drugs. SWHR believes that the FDA should require that research that accompanies an application for a new drug, device or biologic have the appropriate representation of women and minorities in all phases of research. Further, we believe the FDA should disallow or disapprove applications that don’t have enough women to draw the relevant conclusions, don’t provide the required analysis for safety and effectiveness, or don’t include women and minorities at levels in proportion to the disease prevalence in those populations.”

Read Greenberger’s testimony at a congressional briefing today on “Women's Health Can't Wait: The Continued Need for Sex and Gender Based Research” at SWHR.org

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The Society for Women’s Health Research (SWHR®), the national thought leader in the study of sex differences in disease, is dedicated to transforming women’s health through science, advocacy and education. SWHR® advocates for increased public and private funding for women’s health; greater inclusion of women and minorities in medical studies; and analysis of the biological differences between men and women in disease and health issues. For more information, visit SWHR.org.

 

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