The Office of Women's Health e-Update highlights women's health initiatives, meetings, and regulatory safety information from the U.S. Food and Drug Administration (FDA). The e-Update is disseminated via email to the public.
Women's Health Year in Review
Message from the Associate Commissioner
As we continue to face challenges posed by the global COVID-19 pandemic, FDA’s Office of Women’s Health (OWH) has remained focused on our work to protect, promote, and improve the health of women. In this last e-update newsletter of 2021, we are briefly highlighting some of our accomplishments to advance our mission.
In 2022, we will continue to build on this year’s efforts through science, education, and outreach, with the health of women at the forefront of our work. As we approach the end of the year, I would like to thank you for your continued support of OWH, and also acknowledge the hard work and dedication of our talented staff.
We look forward to connecting with you in the New Year.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
WOMEN & COVID-19
This year, OWH held a public webinar focused on COVID-19 Vaccines & Women with Dr. Kaveeta Vasisht, FDA’s Associate Commissioner for Women’s Health and Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research. This webinar aimed to provide our stakeholders with up-to-date information and address questions regarding the COVID-19 vaccines and their use in women.
In order to bridge knowledge gaps in our understanding of COVID-19, we redirected our research priorities in 2021 to focus on health issues specific to COVID-19 and women. Recently, OWH funded extramural research projects include sex differences in post-acute sequalae of SARS-CoV-2 (PASC), COVID vaccines in pregnancy and lactation, and sex differences in real-world treatment and outcomes among diverse individuals infected with SARS-CoV-2/COVID-19.
WOMEN AND DIABETES
There are millions of women and men living with diabetes in the United States. However, diabetes can affect women differently. This past November, in recognition of National Diabetes Awareness Month we launched a new educational video titled “Be Empowered, Understanding Diabetes.” This resource highlights some of the ways diabetes can impact women differently and shares the unique experiences of women affected by diabetes. We encourage you to share the tips and resources found in the video and corresponding blog with anyone you know living with diabetes.
ADVANCING SCIENCE THROUGH RESEARCH
OWH funds extramural and intramural research to improve the health and safety of women and to better understand how sex and gender differences impact FDA-regulated product safety, effectiveness, and usage. OWH drives the research agenda for women at FDA through yearly calls for intramural research to fill critical knowledge gaps. In 2021, OWH funded 8 new intramural research projects from across FDA’s product centers.
In addition, OWH’s research program aims to expand knowledge on medication use during pregnancy and breastfeeding. Ongoing projects include model-informed drug passage into breast milk, assessment of real-world use of pharmaceuticals among pregnancy and lactation and the development of The CURE Pregnancy Treatment Repository application, which will gather data on drugs used during pregnancy for infectious diseases and cancer. Healthcare providers from all over the world can access the platform via the web or mobile app to share and communicate real-world information about the use of existing drugs in pregnant patients to treat cancer and infectious diseases such as COVID-19.
LAUNCHED OWH’S RESEARCH FELLOWSHIP
We launched the OWH Research Fellowship Program. The fellowship program is designed to promote research collaborations between FDA Product Center investigators, a research fellow, and OWH within FDA’s intramural research environment to address critical regulatory science knowledge gaps. We provided this new funding opportunity to FDA researchers to increase the bandwidth for women’s health and sex differences research.
SNAPSHOT OF 2021 OWH PUBLICATIONS
Duggal M, Sacks L, Vasisht, KP (2021) Eligibility criteria and clinical trials: an FDA perspective. Contemporary Clinical Trials, 109: 106515
Vasisht KP, Nugent BM, Woodcock J (2021) Progress and opportunities for women in clinical trials: a look at recent data and initiatives from the US FDA. Med, 2(5):456-459.
Jenkins MR, Munoz MA, Bak D, Chai G, Ready T, South EM, Zinn RL, Zusterzeel R, Woodcock J (2021) Food and Drug Administration Beyond the 2001 Government -Accountability Office Report: Promoting Drug Safety for Women. Journal of Women's Health, 30(7): 927-934.
Nugent BM, Madabushi R, Buch B, Peiris V, Crentsil V, Miller VM, Bull J, Jenkins MR (2021) Heterogeneity in treatment effects across diverse populations. Pharmaceutical Statistics, 20(5):929-938.
NATIONAL WOMEN’S HEALTH WEEK
During National Women’s Health Week (NWHW) this past May, we hosted OWH’s first Twitter Video Chat. This video chat included a partnership with our colleagues in the HHS Office of Women’s Health and focused on sharing insights from federal leaders on maternal health, overall wellness, COVID-19 and more. The chat yielded broad stakeholder engagement, reaching over 2 million people.
OWH SCIENTIFIC SPEAKER SERIES
In 2021, OWH hosted several scientific seminars to educate FDA/HHS-wide staff on the latest scientific evidence and considerations regarding sex and gender considerations on topics such as:
- Sex Differences in Ischemic Heart Disease
- Women and Post-Acute Sequelae of SARS-CoV-2 (PASC)
- The Impact of COVID-19 on Women’s Mental Health
- Uterine Fibroids
- Sex Differences in Antiretroviral Therapy for HIV
ONLINE COURSE: BENCH TO BEDSIDE: INTEGRATING SEX AND GENDER TO IMPROVE HUMAN HEALTH
We are delighted to continue our partnership with NIH’s Office of Research on Women’s Health (ORWH) to develop Bench to Bedside: Integrating Sex and Gender to Improve Human Health. This online course is comprised of a series of 1-hour webinars to help researchers and clinicians explore sex and gender differences that impact health, disease, and treatment in key disease areas. CME will be available in January 2022. The course can be accessed here.
PROMOTING COLLEGE WOMEN’S HEALTH
This year we targeted outreach and education to college women by meeting with individuals and organizations servicing their health needs as part of our College Women’s Campaign (CWC). We invite you to learn more about available resources by visiting our CWC webpage. We also encourage you to use our digital toolkit, available in English and Spanish, and share health tips for college women with your campus community.
EXPANDING OUR CONSUMER EDUCATION MATERIALS
OWH offers consumer educational fact sheets and brochures on a variety of topics relevant to the health of women. Sharing our resources with a diverse population of women is a priority for our Office. This year, we are pleased to share that we successfully translated many OWH consumer education materials into multiple languages. These resources are now available in 20 languages to download and share with the women in your community.
HIGH BLOOD PRESSURE MEDICINES BOOKLET
Our revised high blood pressure medicine booklet is available! This resource includes information about many FDA-approved products that are currently available to treat high blood pressure. We invite you to use the information in our booklet to start a conversation with your healthcare provider about your blood pressure medicine. Visit our webpage to download the booklet, or order a print version at www.fda.gov/womenshealthpubs.
We invite you to learn about the important health topics we discussed in 2021 by reading our Knowledge and News on Women blog posts from this year.
- Making Your Health a Priority in 2021 (January)
- Heart Disease and Women (February)
- HPV (April)
- National Women’s Health Week (NWHW) – Health Screenings (May)
- Fibroid Awareness (July)
- Breastfeeding (August)
- Diabetes (November)