The US Food and Drug Administration Office of Women’s Health (FDA OWH) has just published an update on its activities during the recent years . This report opens a window on current FDA fields of interest in women’s health. Evidently, the role of any regulatory agency is, first, to optimize medical product development and to evaluate product safety and efficacy. OWH also invests in research projects and dictates the exact trial design, and the type of data to be collected and analyzed. Among the fields on which the OWH has focused were early detection of breast cancer, lung cancer in women, vertebroplasty for osteoporotic fracture, HIV, and pregnancy. In the past, clinical trials did not include a desired percentage of women. This was corrected at the beginning of the millennium, as the FDA imposed new rules to allow adequate representation of demographic groups by sex, age, and race/ethnicity in clinical trials, so that evidence-based clinical decisions can be made that are applicable to all patients who will use the medical product following approval.
As for specific menopause issues, dietary supplementations are discussed. Dietary supplements are not subject to FDA approval before being marketed, but the FDA may proceed with regulatory action if it can be shown that the supplement is unsafe. One reason that women take supplements is to relieve menopausal symptoms. It is estimated that up to 79% of women aged 40–60 use botanical dietary supplements . Widespread use enhances concerns about the safety of these supplements. For example, one of the supplements investigated by an FDA OWH-funded study, black cohosh, had been reviewed by the United States Pharmacopeia (USP) and National Institutes of Health (NIH) Office of Dietary Supplements, due to several reports of hepatotoxicity . The FDA investigator compiled a list of lead chemicals and structural motifs that commonly contributed to predictions of adverse events, which may be of use for future experimental designs.
The progress in women’s health research in the past two decades has identified particularly critical areas of women’s health research that need to be investigated. A ‛Women’s Health Research Roadmap’ has recently been developed by the OWH . Interestingly, in the final section of the current article, the authors mention that the OWH is embarking on collaboration on women’s health initiatives at the domestic and international levels, including other government agencies, academia, and the medical product industry.
Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel
Elahi M, Eshera N, Bambata N, et al. The Food and Drug Administration Office of Women’s Health: Impact of Science on Regulatory Policy: An Update. J Womens Health (Larchmt) 2016;25:223-34
Mahady G, Parrot J, Lee C, Yun GS, Dan A. Botanical dietary supplement use in peri- and postmenopausal women. Menopause 2003;10:65–72
Betz J, Anderson L, Avigan M, et al. Black cohosh: Considerations of safety and benefit.
Food and Drug Administration Office of Women’s Health. Women’s Health Research Roadmap.