Through Policy, Research, Education and Outreach
By Robert M. Califf, M.D., Commissioner of Food and Drugs and Kaveeta P. Vasisht, M.D., PharmD, Associate Commissioner for Women’s Health and Director of the Office of Women’s Health, FDA
LinkedIn: Robert Califf
LinkedIn: Kaveeta P. Vasisht
LinkedIn: FDA
Thirty years ago, the U.S. Food and Drug Administration’s Office of Women’s Health (OWH) was established to promote the inclusion of women in clinical trials and to provide leadership on topics related to the health of women. Since its inception in 1994, OWH has been at the forefront of ensuring that the unique health needs of women are prioritized through a multifaceted approach that encompasses policy, research, education, and outreach. In 2024, the office celebrates 30 years of service and paving a pathway to promote and support advancements in the health of women.
Advancing the Health of Women Through Policy and Research
OWH continues to focus on conducting and driving groundbreaking research initiatives. This commitment to women’s health research has led to the agency funding over 450 intramural and extramural research projects. Recent projects include studies to evaluate the application of machine learning algorithms to the management of postpartum hemorrhage, improve the diagnosis and treatment of women with myocardial ischemia and non-obstructive coronary artery disease, and develop a database collating pharmacokinetic information on pregnant people. Research has shown that biological differences between males and females can influence various aspects of health and response to treatment. By advocating for Sex as a Biological Variable (SABV) in research design, analysis, reporting and education, the research efforts help to fill critical knowledge gaps and make changes in regulatory policy and improvements for women.
Furthermore, OWH has been instrumental in promoting diversity and the inclusion of women in clinical trials through its Diverse Women in Clinical Trials initiative. The initiative raises awareness about the importance of the participation of women of different ages, races, ethnic backgrounds, abilities, and those with chronic illnesses and health conditions in clinical trials. Although advancements have been made over the years, opportunities remain to further this progress. The office supports the agency’s efforts to improve clinical trial diversity and the representation of women in clinical trials. This emphasis on inclusivity not only enhances the scientific rigor of clinical research, but also ensures that health care interventions are relevant and effective for all.
OWH also champions better health outcomes on conditions that disproportionately, differently or uniquely impact women. Of particular importance is maternal health—the office strives to understand and address critical knowledge and research gaps to improve maternal outcomes. Additionally, the office maintains a list of available Pregnancy Exposure Registries—studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This effort aims to increase awareness of opportunities to participate in this research and ultimately enhance the understanding of medication and vaccine safety during pregnancy.
The OWH Research Fellowship Program, launched in 2020, continues to advance women’s health. The program promotes research collaborations among FDA experts, research fellows, and OWH within FDA’s intramural research environment, to address critical regulatory science knowledge gaps. The research fellows studied sex differences in response to medicines that treat HIV and Hepatitis C and sex differences in cannabinoid use and response. The program plays a vital role in addressing disparities in women’s health research and further embodies the commitment to addressing complex women’s health issues.
Earlier this year, President Biden released an Executive Order directing a comprehensive set of executive actions to expand and improve women’s health. To support this, OWH is updating the Women’s Health Research Roadmap, outlining OWH’s priority areas in which new or further research is needed and documents research collaborations, both internal and external to the agency. The purpose of this roadmap is to provide a science-based framework to address women’s health research questions and to encourage women’s health considerations across FDA’s research activities.
Education and Outreach Promote Greater Understanding of Women’s Health Topics
OWH’s educational training and outreach initiatives help promote a greater understanding of women’s health and FDA regulated products. In recent years, OWH launched a variety of free public educational opportunities focused on topics such as: pregnancy and lactation medication information; bringing clinical research to patients; sex and gender differences in CBD use; and a public workshop to discuss the impact of menopause on drug pharmacology. When faced with emerging critical health issues, such as the COVID-19 public health emergency, the OWH team mobilizes quickly, leveraging its expertise and resources to disseminate critical information, for example by hosting webinars to discuss the impact of COVID-19 on women during the height of the pandemic.
In an effort to continually meet the needs of the public, OWH launched the Knowledge and News on Women Health (KNOWH) initiative. KNOWH leverages high impact dynamic messaging such as creating engaging video content to effectively deliver messaging on important health topics like uterine fibroids, heart health, and diabetes to educate women on their risk of disease and complications as well as how to prevent and manage health conditions. By meeting women where they are and providing educational resources tailored to their needs, the office’s outreach and education program further protects and promotes the well-being of all women.
OWH is committed to highlighting the unique health care needs of women, supporting women’s health research to advance regulatory science knowledge, set new directions in regulatory policy, and collaborate with interested parties to establish new standards of excellence for women’s health.
For more information please visit: www.fda.gov/womens
This article was originally published on FDA Voices and is reprinted here with permission.
