Women’s Health a Focus for FDA and Biden Administration

June 2, 2024By Adrienne R. Lenz, Principal Medical Device Regulation Expert

FDA’s Office of Women’s Health (OWH) recently celebrated its 30th anniversary.  This office was formed in 1994 to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women.  Given that FDA was founded in 1906 and the Federal Food, Drug and Cosmetic Act went into effect in 1938, the OWH’s thirty years of existence, while an important milestone, constitutes a very small amount of time to be focused on the health of fifty percent of the population. The implication of this is that many women living today have spent the majority of their lives receiving healthcare that may not have been developed with the unique health needs of women in mind or tested in a representative number of women.

In celebration of the OWH anniversary, FDA Commissioner Dr. Robert Califf, and Associate Commissioner for Women’s Health and Director of the Office of Women’s Health, Dr. Kaveeta P. Vasisht, recently shared a statement, Protecting and Advancing the Health of Women Through Policy, Research, Education and Outreach, highlighting the work of the OWH.  The OWH has been involved in funding women’s health research projects, advocating for sex as a biological variable in research design, promoting diversity and inclusion of women in clinical trials, and championing better health outcomes on conditions that disproportionately, differently, or uniquely impact women.

The OWH is updating the Women’s Health Research Roadmap, in support of the Executive Order on Advancing Women’s Health Research and Innovation released by President Biden earlier this year.   The roadmap will provide a science-based framework to address research questions relevant to women’s health and to encourage research activities by FDA and other federal agencies to consider women’s health.

The Executive Order establishes the White House Initiative on Women’s Health Research (Initiative) within the Office of the First Lady to accelerate research related to women’s health.  The Initiative includes requirements for:

  • Furthering integration of women’s health research in federal research programs,
  • Prioritizing federal investments in women’s health research,
  • Galvanizing research on women’s midlife health, and
  • Assessing unmet needs to support women’s health research.

We are honored to have helped many companies bring to market FDA-regulated products that are intended specifically for women, or have been adequately tested in both men and women to ensure both groups can rely upon the results of clinical studies presented in product information. With the White House Initiative and programs offered by OWH, we look forward to supporting continued innovation in this important space.