In today’s day and age, women’s health is more important than ever. There are several international health initiatives directed at providing resources and improving the overall health of women globally. In alignment with that, the FDA also has its own established Office of Women’s Health (OWH). The OWH was established in 1994 with the main mission to serve as the principal adviser to the FDA Commissioner on “scientific, ethical, and policy issues related to women’s health”...

1. FDA’s Office of Women’s Health
By: Madison Wheeler
In today’s day and age, women’s health is more important than ever. There are several
international health initiatives directed at providing resources and improving the overall health
of women globally. In alignment with that, the FDA also has its own established Office of
Women’s Health (OWH). The OWH was established in 1994 with the main mission to serve as
the principal adviser to the FDA Commissioner on “scientific, ethical, and policy issues related
to women’s health”.1
A key part of the OWH’s mission is accomplished by funding research grants for 1-2
studies each year that address women’s health issues and the impact of gender differences on
the safety and efficacy of drugs and medical devices. These studies also typically address certain
regulatory questions when it comes to the effects of gender on FDA-regulated products. In 2020,
one of the studies that the OWH funded was on the sex differences in Alzheimer’s disease. This
study investigated novel technologies for the discovery of potential biomarkers and new
therapies for women with the disease. Additionally, the OWH also funded a study in 2020 that
looked at the sex differences in the expression of biomarkers that could diagnose early HIV-1
infections.2
On top of the groundbreaking research that the OWH funds annually, the office also
works towards increasing the number of diverse womenin clinical trials. It is important to
include women of different ages, ethnic backgrounds, and disabilities in clinical trials to ensure
the safety and efficacy of the product are consistent across all populations. The OWH’s Diverse
Women in Clinical Trials Initiative also helps the industry share best practices about clinical
trial design, recruitment, and subpopulation analyses.3
The OWH has also founded numerous community outreach programs such as the
Mammography Awareness Initiative, Use Medicines Wisely Campaign, and the Take Time to
Care Program which provides reliable health information targeted at Women’s Health. I have
been honored to work with several firms that have women’s health products during my time
with EMMA International. Whether it is during the clinical trial phase of these products or
assisting with the regulatory submissions to get these products on the market, it is a great
feeling knowing that I am playing a small part in the global initiative towards equality in the
healthcare space for women. If you need help with any quality, regulatory, or compliance aspect
1 FDA (December 2019) Office of Women’s Health retrieved on 03/07/2021 from: https://www.fda.gov/about-
fda/office-commissioner/office-womens-health
2 FDA (July 2020) Listof OWH Research ProgramAwards by FundingYear retrieved on 03/07/2021 from:
https://www.fda.gov/science-research/womens-health-research/list-owh-research-program-awards-funding-year
3 FDA (August 2019) Women in Clinical Trials retrieved on 03/07/2021 from:
https://www.fda.gov/consumers/womens-health-topics/women-clinical-trials

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