On July 10 the Endocrine Society and the Society for Women’s Health Research (SWHR) co-sponsored a briefing entitled, “Maximizing the Benefits of Biomedical Research: A Tale of Mice and WoMen, Why We Need to Balance the Study of Males and Females.” Speakers included former Endocrine Society president Teresa K. Woodruff, PhD; Phyllis Greenberger, president and CEO of SWHR; Janine Clayton, MD, director of the NIH Office of Research on Women’s Health; and Marsha B. Henderson, MCRP, director of the Office of Women’s Health at the FDA. The briefing was designed to educate members of Congress and their staff about the need to include both sexes in all phases of biomedical research and support legislative language to help NIH implement new policies to promote sex inclusion in preclinical research.
During the briefing, Greenberger introduced the topic and described how drugs can affect men and women differently. Woodruff then discussed the need to address sex inclusion in preclinical research, highlighting recent Endocrine Facts and Figures data showing several endocrine-related conditions that disproportionately affect women. Clayton and Henderson then described new policies and actions by federal agencies to promote the study of sex as a biological variable in research and clinical trials. Following the presentations, audience members took the opportunity to engage speakers in a question and answer session.
The briefing generated tremendous interest on Capitol Hill and among organizations throughout Washington DC. Available seats were rapidly filled and speakers delivered their presentations to a full room. In addition to Hill staff, attendees included representatives from federal agencies, research advocacy organizations, other scientific societies, and media outlets. The briefing was covered by various media outlets.
The event was particularly timely, as the Senate Health, Education, Labor, and Pensions (HELP) Committee is exploring ways to modernize the drug development process from basic research through FDA approval. The Endocrine Society believes that appropriate consideration of sex as a biological variable in research is necessary to maximize the efficiency of the drug pipeline. Recently, the NIH issued a notice indicating the expectation “that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies” in grant applications, unless strong justification is provided to support the study of only one sex. The Society believes this a good first step, but legislation is still needed to give more teeth to the NIH policy intent.
To further advance the issue with Congress, Woodruff and Society staff met with the offices of several Senate HELP Committee members to discuss the importance of balancing males and females in preclinical research and provide proposed text that could be incorporated into legislation.