OWH promotes and conducts research initiatives that facilitate FDA regulatory decision-making and advance the understanding of sex differences and health conditions unique to women. FDA OWH scientific programs support scientific research, workshops, and initiatives that:
- Advocate for the inclusion of women in clinical trials and data analyses by sex;
- Look for potential sex-based differences in the safety and efficacy of FDA-regulated medical products;
- Promote a better understanding of health conditions that solely or disproportionately affect women.
Learn more about OWH-funded research
Research has shown that biological differences between men and women—differences due to sex chromosome or sex hormones—may contribute to variations seen in the safety and efficacy of drugs, biologics, and medical devices. FDA’s regulations and guidance acknowledge that understanding mechanisms of sex differences in medical product development is crucial for regulatory decisions and optimal treatment outcomes.
Disease sometimes manifests differently in women than in men; sometimes women also respond differently to FDA-regulated products. A number of factors can influence these differences. Intrinsic factors (e.g., genetics, hormones, body size, sex-specific physiology), extrinsic factors (e.g., diet, sociocultural issues, environment), or interactions among these and other factors can play an important role in how women respond to therapies. Characteristics associated with female sex (e.g., size, age, co-morbidities, past pregnancies) may be associated with differences in the safety or effectiveness of a particular medical product.
Because these differences in health, disease, and treatment response can occur throughout a woman’s life―and may be substantial, depending on her stage of life―a deeper analysis is needed of how regulated products work in diverse populations of women. For example, it is important to understand whether and how hormonal changes affect product performance at the onset of puberty, during the menstrual cycle, during pregnancy, and during the transition from pre-menopause, to perimenopause, to post-menopause.
We must improve our understanding of how to identify and interpret sex differences in addition to understanding how these differences might affect treatment. This is especially important, given the many evolving new technologies and scientific fields, such as nanotechnology; pharmacogenomics; stem cells; and novel imaging techniques and methods used to improve diagnosis. Advances in our understanding in these areas will contribute to FDA’s ability to carefully evaluate the many innovative therapeutic products in the development pipeline.
New clinical trial and study designs could help ensure effective use of small samples and sub-population analyses. New methods, processes, and tools can help evaluate medical device designs, predict toxicity, or predict the safety and efficacy of FDA-regulated products and guide medication dosing for women.
Learn more in the Women’s Health Research Roadmap
In 1994, shortly after its creation, the FDA’s Office of Women’s Health (OWH) established a program to support FDA research and development activities related to advancing the science of women’s health. Since then, OWH has funded research projects addressing health issues affecting women across their lifespan, including—for example—endocrine and metabolic disorders, cardiovascular disease, breast cancer, sexually transmitted infections, and issues related to pregnancy. Results from OWH-supported research have led to safety labeling changes for some medical products, guidance for industry on product development, new evidence-based communications about FDA-regulated products used by pregnant women, and regulatory decisions related to FDA-regulated products used by women.
Since its inception, OWH has worked closely with FDA centers, where many research activities are underway. OWH has helped to expand existing research projects and foster new collaborations. OWH has also worked with other government agencies, academia, women’s research organizations, and other stakeholders to foster and facilitate research projects and scientific forums. These combined efforts have helped to advance our understanding of women’s health issues. They have furthered the development of new tools and approaches for informing FDA decisions about the harm or the safety and effectiveness of FDA-regulated products that are used not only by women, but by all Americans.
In addition to OWH-funded intramural and extramural research, FDA product centers and offices directly support scientific research in the form of grants, cooperative agreements, or contracts. OWH collaborates with other FDA research programs, like the Critical Path Initiative, to better integrate women’s health research questions into their research activities.
OWH also works with a variety of external research partners. For example, collaborations may involve special projects conducted with other government agencies and external partners to help FDA leverage all available technologies, expertise, and resources when addressing complex women’s health research questions.