FOR IMMEDIATE RELEASE
November 29, 2016 - NEW YORK — Last week, congressional leadership revived negotiations for the 21st Century Cures and Innovation for Healthier Americans legislation, which lack crucial provisions to protect female patients. The House is expected to hold limited debate and a vote, without opportunity for amendments, later this week. Ellen Hershkin, National President of Hadassah, The Women's Zionist Organization of America, Inc. released the following statement, calling for improvements and a thorough congressional review process.
Hadassah is a proud endorser of the Research for All Act (H.R. 2101) and we are extremely disappointed that key provisions from that legislation were not included in 21st Century Cures. Women and men often present different symptoms for the same diseases and react differently to certain drugs, medical devices, and treatments — putting women at risk for misdiagnoses, ineffective treatments and compromised care.
While 21st Century Cures Act does include important measures to promote inclusion and analysis of female animals, tissues and cells in NIH-funded research, the bill lacks essential protections for the adequate inclusion of women in FDA-reviewed clinical trials. This is especially necessary given the bill’s emphasis on expedited development and review of medical products.
Hadassah urges the House to add the Research for All Act as an amendment to 21st Century Cures. The FDA would be required to ensure that products granted expedited approval still include adequate subgroup analysis and guarantee product safety and effectiveness for women and men. Including this amendment would also enhance the representation of females in NIH-funded research by mandating new and consistent reporting.
For over 100 years, Hadassah, The Women's Zionist Organization of America, Inc. has supported cutting-edge medical care and pioneering medical research at the Hadassah Medical Organization in Jerusalem. We understand, first-hand, how investments in scientific innovation can lead to life-saving treatments and cures. In Israel and here in the U.S., we are also dedicated to ensuring that medical research benefits both women and men.
Any policy to improve the health and well-being of the American people should be constructed and evaluated with the same attention and care we demand of our medical professionals. Members of Congress must take the time necessary to assess the full 21st Century Cures legislation, currently at 966 pages long, and protect patient safety — especially for women.
Through the Day in the District program, Hadassah members nationwide have met locally with over 25 legislators to advocate for the Research for All Act — helping to secure 6 additional cosponsors for the legislation.