FDA Office of Women's Health: Development of a Women's Health Research Roadmap
FDA’s Office of Women’s Health (OWH) was established by Congressional mandate in 1994 with the primary mission to:
- Protect and advance the health of women through policy, science, and outreach.
- Advocate for the inclusion of women in clinical trials and analyses of sex differences.
In support of this mission, OWH has coordinated a research program that funds 1-2 year scientific projects that address potential sex-based differences in the safety and efficacy of FDA-regulated medical products and promote a better understanding of health conditions that solely or disproportionately affect women. Over the years, these projects have helped the Agency identify sex-based safety issues, improve product labeling, and draft new regulatory standards. In 2013, OWH began a process to develop a women’s health research roadmap that aims to outline the future strategic direction for OWH’s research program, maximize the impact of OWH research funding, and better coordinate women’s health research across the Agency. The goal of the research roadmap development process is to draft a women’s health research plan that aligns OWH’s research priorities with those of FDA’s Centers and remains flexible enough to adapt to emerging issues.
OWH is using a 3-pronged strategy to develop the women’s health research roadmap:
- Evaluate OWH’s existing research portfolio to determine regulatory impact and perform a gap analysis to identify critical women’s health issues that have not been addressed.
- Conduct discussions with representatives from the FDA Centers/Offices to identify Center- level women’s health research priorities and regulatory questions.
- Based on information gathered in Steps 1 and 2, develop a list of research priorities and questions that will be vetted with key stakeholders within and outside of FDA
OWH is performing an outcomes assessment of its research portfolio to determine the regulatory impact of OWH-funded research. In 2007, OWH published a manuscript1 examining the first 10 years of research funding. The accompanying manuscript (SPECIAL REPORT: The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy) provides relevant background for the questions posed below and the report is now being updated to describe how OWH-funded projects have impacted regulatory policy over the past 20 years. OWH is also performing a gap analysis to assess what questions and research areas we have successfully addressed, as well as issues or needs which remain unmet.
OWH has conducted preliminary meetings with the women’s health liaisons and scientists in CDER, CBER, CDRH, CFSAN, and NCTR regarding Center-level research priorities. These discussions will be expanded to all the FDA Centers and appropriate Offices and a larger group within those Centers and Offices to better identify research areas and regulatory questions.
OWH is seeking input from the FDA Science Board regarding the roadmap development process and potential regulatory research priority areas and research questions.
Questions for the FDA Science Board:
- What changes, if any should OWH make to its approach for identifying research questions and priorities from internal and external partners?
- Are there any research priority areas/ questions or emerging women’s health issues that should be considered for the research roadmap?
- What metrics/ criteria do you recommend for measuring the success of OWH-funded research projects and the research roadmap?
- Are there any examples of successful research roadmap or development plans within a regulatory environment that you can share?
1Obias-Manna, D., Scott, P.E., Kaczmarczyk, J., et al, (2007) The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy. Journal of Women’s Health,16(6),807-817.