When the FDA’s Office of Women’s Health was created by congressional mandate in 1994, it signaled an inflection point at which federal health agencies recognized a need for leadership to grapple with pressing women’s health concerns.
By the early 1990s, there was a growing consciousness of the emerging science of sex and gender differences in health that mobilized support to reverse a 1977 FDA guidance preventing women of reproductive age from enrolling in Phase I and II clinical trials, and to begin actively recruiting female participants in clinical research. The Office of Women’s (OWH) Health also championed women’s health by pioneering outreach strategies to advance women’s health literacy, while at the same time engaging with stakeholders and advocacy groups to inform the FDA’s regulatory work. OWH was also charged with the responsibility of administering a robust grant program to support cutting edge research on women’s health issues and sex differences in medical products and nutrition.
These programs evolved over time in response to scientific advancements and changes in the regulatory environment, as well as innovations in communications technology. Throughout this evolution, OWH’s pioneering directors have played a pivotal role in promoting the FDA’s capacity to respond to women’s health issues. You can learn more about their work in the oral histories profiled below.
Ruth B. Merkatz, PhD, RN, FAAN, was the first Director of the FDA Office of Women’s Health (1994-1996), and before that served as a Special Assistant on Women’s Health Issues to Commissioner David Kessler (1991-1994). During her tenure at the FDA she not only stood up the Office of Women’s Health and established its research program, but helped the agency to grapple with issues ranging from women’s participation in clinical trials, gender differences in health, silicone breast implant safety, the Mammography Quality Standards Act, HIV/AIDS in women, contraceptive labeling, etc. After leaving the FDA in late-1996, Dr. Merkatz served as Director of Women’s Health at Pfizer, Inc. and later as the Director of Clinical Development in Reproductive Health at the Population Council.
Learn more about her impact on women's health by reading Ruth Merkatz's Oral History
Audrey Sheppard served as Deputy Director of Women’s Health (1994-1996) and then Acting Director of Women’s Health (1996-1999), playing an integral role in standing up the Office of Women’s Health, building stakeholder relationships and developing OWH’s outreach strategy. She was a principal architect of OWH’s longest running health communications campaign, Women’s Health: Take Time to Care, and played a key role in collaborating with the DHHS Office on Women’s Health and the NIH Office of Research on Women’s Health in studying the health impacts of silicone breast implants. After leaving the FDA, she remained active in advocating for women’s health issues related to FDA-regulated products as a health consultant.
(Photo Credit: Veteran Feminists of America)
Learn more about her impact on women's health by reading Audrey Sheppard's Oral History
Susan Wood, PhD, served as the third head of the FDA Office of Women’s Health under the title of Assistant Commissioner of Women’s Health (2000-2005). Under her leadership, OWH advanced the FDA’s efforts to increase enrollment of women in clinical trials, track sex-based data on drug safety and efficacy, funded pioneering research on gender differences in heart disease and also helped the FDA confront adverse events linked with silicone breast implants and hormone therapies. When Dr. Wood resigned from the FDA in 2005 she indicated it was due to the agency’s refusal to follow medical officers’ recommendations to approve the OTC application for the emergency contraceptive pill, Plan B. After leaving the FDA, Dr. Wood served as the Director of the Jacobs Institute of Women’s Health Services at George Washington University.
(Photo Credit: C-Span, “Women's Reproductive Health Policy” (17 October 2005))
Learn more about her impact on women's health by reading Susan Wood's Oral History
Kathleen “Cook” Uhl, MD, came to the FDA in 1998 as an officer in the Public Health Service and initially worked as a medical reviewer in the Office of Clinical Pharmacology. From 2006 to 2010 she served as the Assistant Commissioner for Women’s Health and the Director of the FDA’s Office of Women’s Health, where she oversaw the expansion of both the office’s research program and stakeholder engagement efforts. In 2010 she was appointed Deputy Director of the Office of Medical Policy and from 2013 to 2019 she served as the Acting and then permanent Director of the Office of Generic Drugs, implementing organizational, staffing and work-planning changes mandated by the Generic Drug User Fee Amendment and its reauthorization. Dr. Uhl retired from the FDA in March 2019.
Learn more about her impact on women's health by reading Kathleen Uhl's Oral History
Marsha B. Henderson, MCRP joined the FDA Office of Women’s Health (OWH) in 1998 as a deputy director. She spearheaded new communication strategies to engage stakeholders, improve women’s health literacy and promote awareness of pioneering research on sex as a biological variable funded by the OWH. Notably, she helped design and launch the Take Time to Care Campaign, the My Medicines organizer and the FDA chart of approved birth control products. Ms. Henderson was appointed Associate Commissioner for Women’s Health in 2011 (after acting in that position for a year), bringing a new strategic vision to OWH with the creation of the office’s first Women's Health Research Roadmap. She retired from the FDA in December 2018.
Learn more about her impact on women's health by reading Marsha Henderson's Oral History