The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Abstract

The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies

“…Women are un-fertile in the post-menopausal age, and illnesses increase dramatically in this age; thus, excluding menopausal women makes little sense. The use of a physiologically-based pharmacokinetic approach (PBPK) can facilitate the investigation of SGD by predicting biological differences in all PK parameters [137]. However, PBPK may not detect the gender effect.…”

“…To include pregnant and breastfeeding women in RCT requires the understanding of the differences in the PK and, as already mentioned, the anticipation of reproductive toxicology studies and pre-and post-natal developmental studies would be beneficial [142]. The construction of a PK–PD model, measuring drug levels in parallel with medication effects, would help to reach evidence-based decisions in dose schedules during gestation [137]. Some of these models are now available [156], but they do not incorporate gender aspects.…”

<p>Cardiovascular Diseases in Women: Policies and Practices Around the Globe to Achieve Gender Equity in Cardiac Health</p>

“…41 FDA Office of Women's Health-funded projects have contributed to highlighting major gaps in the field of CVDs in women. 42 Nonetheless, apart from the limited number of high-quality sex-specific studies, the AHA recognized another challenge in CVD in women: CVD was the leading cause of death in females, yet many were unaware of this threat. 43 In 2002, the NHLBIalong with (among others) the AHA -teamed up to sponsor the Heart Truth awareness campaign with red dress as a centerpiece symbol and the message "Heart disease doesn't care what you wear: it's the #1 killer of women", aimed at raising women's awareness regarding their cardiac health and enhancing the knowledge of health professionals and researchers on this issue.…”

US Food and Drug Administration Office of Women's Health: Promoting Therapeutic Optimization in Women

“…20 The findings from OWH-funded and -conducted research have resulted in regulatory actions to promote safer and more effective medical products, including safety labeling changes, new guidance for industry on product development, standardization for vaccine clinical data, measures for evaluation of tampons and condoms, and evidence-based support for consumer decision making. 21 Additionally, the OWH advances its women's health agenda through engagement and education on issues that are critically important to the health of women, such as how sex and gender influence opioid and nicotine use. The OWH has supported public meetings and workshops, publications, professional education and training, and public outreach and communications materials, some of which are highlighted in Table 3.…”

“…The findings from OWH‐funded and ‐conducted research have resulted in regulatory actions to promote safer and more effective medical products, including safety labeling changes, new guidance for industry on product development, standardization for vaccine clinical data, measures for evaluation of tampons and condoms, and evidence‐based support for consumer decision making 21 …”