The White House has announced a program titled the Initiative on Women’s Health Research, which among other things will amplify ongoing programs at the FDA designed to improve health outcomes for women. The White House program may spur investments in women’s health as well, however, and may present life science companies with new opportunities.
The FDA’s Office of Women’s Health was established in 1994 with the goal of advancing the agency’s ability to evaluate the differences between women and men in health care product safety and efficacy. This office issues grants each year for research into women’s health, such as for differences in response to gene therapy using adeno-associated viruses. There is also an emphasis on responses to cardiovascular devices that may produce xenoestrogens in women, which are suspected of promoting the formation of breast cancer.
The initiative recently announced by the Biden administration is much broader and encompasses the entire Department of Health and Human Services (HHS) rather than just the FDA. Also involved in this program are the Department of Defense, the National Science Foundation and the Centers for Disease Control and Prevention. The National Institutes of Health and the Centers for Medicare and Medicaid Services are two other HHS agencies that are listed as participants in this initiative.
This program has been established within the Office of the First Lady and will be led by a chairperson who will also sit on the White House Gender Policy Council. HHS will provide funding and administrative support, although funding will be limited to existing appropriations. Each of the participating departments and agencies must bear the cost of their own participation in this program. Among the missions of the initiative is identification of opportunities for additional investment from across the federal government. The Department of Defense has its own health research programs, an example of the resources that could be leveraged for the Initiative on Women’s Health Research.
This program includes an emphasis on health disparities faced by women, including those related to race, ethnicity, age, and socioeconomic factors. This initiative will promote a more rapid translation of federal research into practical benefits for patients and providers and will seek to establish public-private cooperative research programs. Within 45 days of the November 13 announcement, the members of the initiative’s directing council will deliver a list of concrete actions that can be undertaken to advance research into women’s health.
First Lady Jill Biden will oversee this program along with the inaugural chairwoman, Carolyn Mazure, a psychologist at the Yale University School of Medicine. Mazure’s research has been focused primarily on the development of models for depression, and she serves as the Norma Weinburg Spungen and Joan Lebson Bildner Professor of Psychiatry and Psychology at Yale Medicine. Mazure has also served at NIH and founded the Women’s Health Research program at Yale University.
In addition to the FDA’s Office of Women’s Health, this initiative will be able to leverage the NIH Office of Research on Women’s Health (ORWH) and women’s health research programs at the U.S. Department of Veterans Affairs. Other resources that could be applied toward this initiative are women’s health research programs that have been established at several academic medical centers across the U.S. This includes programs at the University of North Carolina at Chapel Hill, Cedars-Sinai in Los Angeles, and the Medical College of Wisconsin in Milwaukee.
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