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April 2019 Office of Women's Health e-Update

FDA Office of Women's Health celebrates National Minority Health Month. Photo collage of women of various ethnicities.

Message from the Acting Associate Commissioner

Over the past several weeks, it has been a pleasure to experience how the Office of Women’s Health team works to promote and advance the health of women through scientific research, outreach and education. Last month, we held our scientific seminar series and hosted Dr. Hadine Joffe, MD, Executive Director of the Connors Center for Women’s Health and Gender Biology at Brigham and Women’s Hospital. Dr. Joffe discussed the influences of sex and gender on sleep in midlife women, a topic that is relevant to so many women. Next month, we will host Dr. Saralyn Mark, MD, an endocrinologist, geriatrician, and women's health specialist. Dr Mark will discuss findings and recommendations from NASA’s decadal review of sex and gender-based differences. We look forward to an engaging and informative session.

I also want to inform you of an upcoming continuing education webinar hosted by FDA’s Division of Drug Information targeting health care professionals. OWH staff will be providing an overview of current regulatory practice regarding the consideration of sex differences, the importance of the Sex as a Biological Variable (SABV) initiative, and future opportunities to further integrate SABV through collaboration in regulatory, research, and clinical care environments. To register for the online meeting, please visit: https://collaboration.fda.gov/ddi042319/event/registration.html

In closing, this month marks National Minority Health Month. OWH has numerous women’s health materials available in English, Spanish, and other languages. I encourage you to utilize these resources in your outreach to women of diverse backgrounds to help them learn more about making healthy choices and how to safely use medicines. We also continue to collaborate with our colleagues in the FDA’s Office of Minority Health and Health Equity. Please visit OWH’s website for additional resources to support your outreach to women of diverse backgrounds. 

Kaveeta Vasisht, MD, PharmD 
Acting Associate Commissioner for Women's Health
Deputy Director

Women's Health Highlights

FDA approves first treatment for post-partum depression

The U.S. Food and Drug Administration approved Zulresso (brexanolone) injection for intravenous (IV) use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD.

This approval marks the first time a drug has been specifically approved to treat postpartum depression, providing an important new treatment option," said Tiffany Farchione, M.D., acting director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research.

FDA approves new treatment for osteoporosis in postmenopausal women at high risk of fracture

The U.S. Food and Drug Administration approved Evenity (romosozumab-aqqg) to treat osteoporosis in postmenopausal women at high risk of breaking a bone (fracture). These are women with a history of osteoporotic fracture or multiple risk factors for fracture, or those who have failed or are intolerant to other osteoporosis therapies.

FDA approves new device for treating moderate to severe chronic heart failure in patients

The U.S. Food and Drug Administration approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization therapy to restore a normal timing pattern of the heartbeat. The FDA gave the device a Breakthrough Device designation because it treats a life-threatening disease, heart failure, and addresses an unmet medical need in patients who fail to get adequate benefits from standard treatments and have no alternative treatment options.

FDA advances landmark policy changes to modernize mammography services and improve their quality

FDA announced important new steps to modernize breast cancer screening and help empower patients with more information when they are considering important decisions regarding their breast health care.

Fact or Fiction: What to Know About Smoking Cessation and Medications

Tobacco use is the leading preventable cause of death in the United States, resulting in more than 480,000 deaths annually. Almost 70 percent of current smokers report wanting to quit smoking, but quitting can be hard and often takes multiple attempts. A variety of FDA-approved medications are available to help people successfully quit smoking. During a January 26, 2018 FDA public hearing focused on FDA’s approach to evaluating nicotine replacement therapies, FDA heard concerns about misperceptions around smoking cessation medications and we want to help separate fact from fiction.

Call to Action

April is Minority Health Month!
Look to FDA for resources to support your outreach to women of all diverse cultural backgrounds. 

Save The Date! National Women’s Health Week is May 12 – 18, 2019  

National Women's Health Week May 12-18, 2019

Join OWH as we spread the word about women’s health and empower women to be healthy throughout their lives. 


Participate in Upcoming FDA Meetings

Webinar: Precision Medicine and Minority Health (sponsored by the FDA Office of Minority Health and Health Equity)
April 23, 2019

Antimicrobial Drugs Advisory Committee Meeting Announcement
April 25, 2019

Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities 
April 29, 2019

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