The FDA’s Critical Focus on Women’s Health – FDA.gov

By: Amy Abernethy, M.D., Principal Deputy Commissioner, Kaveeta Vasisht, M.D., Pharm.D., Acting Associate Commissioner for Womens Health, Office of Womens Health, and, CAPT Terri L. Cornelison, M.D., Ph.D., Chief Medical Officer and Director, Health of Women Program, Center for Devices and Radiological Health

For the past 25 years, the U.S. Food and Drug Administration's Office of Womens Health has forged a pathway fostering and supporting advancements in the health of women through its 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 individuals 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 Womens Health (the Office) 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 our mission through the foundational principle that Sex as a Biological Variable should be factored into research design, analysis, reporting, and education. Our work in womens health also reminds us that issues pertinent to women are relevant to many others.

The Office of Womens Health has led workshops and collaborated with other agencies, industry, professional associations, and advocacy groups to address issues that are critically important to the health of women. The Office has provided nearly $40 million in research funding supporting more than 380 womens health projects, including research on cancer, HIV, osteoporosis, and the number one killer of women, cardiovascular disease. In addition, the Office brings world renowned speakers to provide educational seminars to FDA staff on the importance of sex and gender considerations in regulatory science.

The Office of Womens Health also works to promote and secure the inclusion of women in clinical trials and identifies and monitors the progress of crosscutting and multidisciplinary womens health initiatives. Those initiatives include emerging public health issues that require additional study, including, for example, how sex and gender influence opioid and nicotine use.

Last year, in collaboration with the FDA's Center for Drug Evaluation and Research and itsCenter for Tobacco Products, the Office of Womens Health hosted a 2-day public meeting, Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender. This meeting addressed these important issues and spotlighted the influences of sex and gender that lead men and women to initiate and experience substance use disorders differently. The Office has published the conference proceedings and is funding research to better understand the public health impact of sex differences on the genetics of smoking-related illness.

The FDAs Office of the Commissioner recently designated the Office of Womens Health to serve on the Task Force on Research Specific to Pregnant and Lactating Women. Established in 2016 by the 21st Century Cures Act, the Task Force advises the Secretary of Health and Human Services (HHS) about gaps in knowledge and research on safe and effective therapies for pregnant and lactating women. In September 2018, the Task Force submitted its report and 15 recommendations to HHS and Congress. Because of its work, the Task Force was extended for another two years and the Office of Womens Health continues to provide leadership and guidance to the Task Force on the implementation of these recommendations.

To help guide ourwork in the many areas that affect womens health, the Office of Womens Health created the Womens Health Research Roadmap, which highlights research priority areas, including: advancing safety and efficacy of FDA-regulated products; improving clinical study design and analyses; using novel modeling and simulation approaches; advancing biomarker science; expanding data sources and analysis; improving health communications; and, using emerging technologies to support identification of sex differences.

To help measure the impact and outcomes of programmatic initiatives, the Office developed the Research Impact and Outcomes Framework, a first-of-its kind, metric-driven framework, whichenables the Office to evaluate research on conditions that affect women disproportionately, as well as studies on sex differences that impact the use of FDA-approved, cleared, or market authorized products. The Research Impact and Outcome Framework is used prospectively to evaluate research proposals under consideration for funding by the Office based on how well the research aligns with the Offices mission and research priorities. The frameworks retrospective metrics are used to evaluate and assign value to a projects impact on womens health from a regulatory perspective, to help the Office of Womens Health identify gaps in its research portfolio, and to help the Office determine future funding priorities.

In 2019, the Office of Womens Health funded research projects on pulmonary embolism, which is the blockage of blood flow to the lungs by blood clots, and a leading cause of maternal death,and the development of an artificially-intelligent virtual pregnant woman modeling suite to support regulatory decisions. Funding was also allocated to evaluate the labeling compliance of dietary supplements targeted specifically to women, as well as evaluation of potential contamination of products that contain live microbes, with special emphasis on pregnant women and lactating women, and infants.

The Office is also providing funding for malaria research, utilizing model-informed drug development to facilitate antimalaria dosing in pregnant women. Other research funded in 2019 includes research to address patient reported outcomes during breast cancer drug development, evaluating the clinical comparability of U.S. vs. non-U.S. clinical trial data for FDA-regulated medical devices for weight-loss treatment, and funding for research on the use of computational models to evaluate the safety and effectiveness of vaginal heat therapy devices.

Take Time to Care is one of the Office of Womens Health first public education programs. It is a multi-faceted program that disseminates FDA health education materials through outreach activities and collaborative partnerships with national womens health and health professional organizations, community and faith-based institutions, industry, universities, and other government agencies. Utilizing this outreach collaboration model, the Office of Womens Health developed and continues to implement national outreach campaigns, including such initiatives as the Diverse Women in Clinical Trials, the Use Medicines Wisely Campaign, the Pink Ribbon Sunday Mammography Awareness Initiative, and, the College Womens Health Campaign.

Ensuring women have access to safe medical products on the market and that these products meet their health care needs are top priorities for the FDA. In 2019, the FDAs Center for Drug Evaluation and Research (CDER) approved a variety of new therapies to help advance womens health. Notably, CDER approved a new targeted therapy for patients with a certain type of metastatic breast cancer, a new biologic drug to treat osteoporosis in certain postmenopausal women at high risk of breaking a bone, a new drug to treat premenopausal women with acquired, generalized hypoactive sexual desire disorder (low sexual desire), and the first FDA-approved drug specifically for the treatment of adult women with postpartum depression.

The FDAs Center for Devices and Radiological Health (CDRH) also recognizes that sex and gender may have considerable impact on health, and on interaction with medical devices. As we learn more about sex- and gender-based differences in the performance of medical devices and new innovations become a reality, we work to ensure that our policies continue to evolve with the current science.

In 2016, CDRH created its Health of Women Program to address the steadily growing importance of sex- and gender-specific issues that arise regarding medical technology design and development, clinical trial design, and other medical device-related matters.

In September, 2019, CDRH unveiled a new Health of Women Program Strategic Plan, and is seeking input from stakeholders to help shape its implementation. The CDRH Health of Women Program and its Strategic Plan extends beyond reproductive and gynecologic health. The approach is comprehensive it considers a womans entire body, including health conditions specific to women, conditions more common or more serious in women, distinct causes or manifestations in women, different outcomes or treatment options in women, and conditions with higher morbidity or mortality in women.

Through the Health of Women Program, CDRH researchers, reviewers, and analysts are considering how sex and gender are factored into research design, device development, and analyses of studies in humans, vertebrate animals, tissue cultures and primary cell lines.

This work being led by CDRH is an important step forward for the FDA. Along with other centers and offices across the FDA, it amplifies the Office of Womens Health foundational principle that considerations of sex and gender should be factored into research design, analysis, reporting and education.

The FDA takes very seriously its long-standing commitment and involvement in medical science and growth in our overall understanding of, and approach to, womens health. The absolute need for research, data, and insight that reflects the overall health of a woman and the foundational principle of Sex as a Biological Variable remains at the forefront of the work we do agency-wide in carrying out our mission to protect and promote public health.

FDA actions to protect womens health over the past quarter century are memorialized in the FDAs History Vault. Whether through accelerating an approval, removing a product from the market, or by issuing guidance on nutrition and dietary supplements, the FDA has used its regulatory authorities to advance womens health.

In honor of the 25th anniversary of the Office of Womens Health, the FDA History Office has created an exhibit highlighting the agencys long-standing commitment to protecting and promoting womens health. These historical artifacts and images are currently on display at the FDAs White Oak Campus in Silver Spring, Maryland, and can also be viewed remotely on FLICKR.

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The FDA's Critical Focus on Women's Health - FDA.gov