The FDA’s Critical Focus on Women’s Health

For the past 25 years, the U.S. Food and Drug Administration’s Office of Women’s Health has forged a pathway fostering and supporting advancements in the health of women through our work across the agency and with stakeholders. Developments in science have advanced our understanding of the unique role that sex and gender play in health and disease. Sex refers to an individual’s biological characteristics, stemming from chromosomal complement. Alternatively, gender refers to the social construct by which we define ourselves as woman, man or other. The Office of Women’s Health was established in 1994 and throughout its history has protected and advanced the health of women through science, policy, education, and outreach, and has advocated for the inclusion of women in clinical trials. The Office achieves its mission through the foundational principle that Sex as a Biological Variable should be factored into research design, analysis, reporting, and education. Our work in women’s health also reminds us that issues pertinent to women are relevant to many others.

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