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November/December 2018 Office of Women's Health e-Update

Image of Marcia Henderson, writing Thank You

Message from the Director

After 40 years, I am retiring from the federal service and with much appreciation I thank all of you for your support of the FDA’s Office of Women’s Health (OWH). Over the last 22 years in the OWH, I have had opportunities to serve in leadership roles guiding our mission to protect and advance the health of women through policy, research, and outreach.

First, I want to thank the partner organizations and individuals who have shared FDA health and safety information with their networks and communities. It is through these collaborations that women were able to receive the information they needed to make informed choices about the medicines, medical devices, foods, and other FDA-regulated products used every day by themselves and their families. From historic changes in regulation and guidance to our outreach initiatives, it was through this support that our activities and award-winning campaigns were powered.

OWH has consistently catalyzed sex differences and women’s health research initiatives, contributing to the development of guidance documents for drug and device development for men and women. The first FDA Women’s Health Research Roadmap and the Research Impact and Outcomes Framework are two examples of OWH’s commitment to advancing the science of women’s health and improving the health of women while also providing expertise to encourage researchers to incorporate a sex and gender lens. Other activities, including OWH’s Take Time To Care Program, has reached over 120 million people with FDA consumer information in 19 languages. Simultaneously, OWH became a leader in supporting research studies on drug-induced QT prolongation, enhancing health for mother and child through our pregnancy exposure registries initiative, and fulfilling an ongoing commitment to science, professional education, and consumer outreach amidst the FDASIA Section 907 Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data.

I leave OWH stronger than ever. The science has evolved and so has FDA regulatory decision-making, understanding of sex differences, and focus on health conditions unique to women. However, there is still more do. I encourage you to continue looking to OWH as this office supports FDA’s regulatory mission, incorporates Sex as a Biological Variable as a core component, and provides women and their families with resources to keep them safe.

In retirement, I am not just going away but will move on to other opportunities that continue to serve.

Marsha Henderson, Associate Commissioner for Women's Health

Women's Health Highlights

Free Publications for Women: A New Look
The FDA Office of Women’s Health (OWH) developed two new consumer publications this year, the Women and Pain Medicines fact sheet and the Caring for Others: Resources to Help You fact sheet. The Women and Pain Medicines fact sheet provides a plain language overview of gender-specific pain and information to help women make safe decisions regarding pain medication use. The Caring for Others: Resources to Help You fact sheet provides tips for caregivers and other FDA resources to help keep loved ones safe and on track with their medicines and medical devices.
Over the next few months, we encourage you to stay tuned as we refresh the overall look of publications, ensuring that we continue to provide women free health information in a clear and easy-to-read format.

FDA In Brief: FDA takes steps to advance the safety and accuracy of blood glucose monitors to empower patients with diabetes with reliable tools to manage their health
The U.S. Food and Drug Administration issued two revised draft guidances regarding blood glucose monitors used in health care and home settings. These new draft guidances, when finalized, will update two final guidances issued in 2016. The changes are based on additional feedback from stakeholders requesting more clarification on design considerations and recommended standards. This action is part of the FDA’s continuing efforts to improve the development of new blood glucose meters based on feedback from both patients and health care providers, especially on the usability of glucose monitors.

Statement from FDA Commissioner Scott Gottlieb, M.D. and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health, on FDA’s updates to Medical Device Safety Action Plan to enhance post-market safety
"...we’re focusing on several key actions we’re taking to create a more robust medical device safety net for patients through better data. We’re also announcing several new steps related to important health devices that impact women, including surgical mesh for transvaginal surgical repair.”

FDA Voices: Perspectives from FDA Experts
Read the FDA Voice from Jeff Shuren, M.D., J.D. and Jonathan Jarow, from FDA’s Center for Devices and Radiological Health at the U.S. Food and Drug Administration titled, “Inspiring Medical Device Innovation to Combat the Opioid Crisis.”

FDA approves treatment for adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a certain genetic mutation
The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA also approved an expanded indication for a companion diagnostic, to include use with Xospata. Women who are pregnant or breastfeeding should not take Xospata because it may cause harm to a developing fetus or newborn baby.

Call To Action

Women and HIV Resources 1 in 4 people living with HIV in the United States are women, according to the Center for Disease Control and Prevention. Educate the women in your community about HIV testing, prevention, and treatment with these FDA resources.

Food Safety Tips for Healthy Holidays Combating bacteria, viruses, parasites, and other contaminants in our food supply is a high priority for the Food and Drug Administration. But consumers have a role to play, too, especially when it comes to safe food-handling practices in the home. Read 4 tips to help you keep you and your family safe this holiday season

When to Give Kids Medicine for Coughs and Colds The U.S. Food and Drug Administration wants you to be aware of important information about use of medicines for cough and colds in children. Read this consumer update for tips of how to relieve cold and cough symptoms, when to call a doctor, and what to do about fever and other symptoms associated with a cold.

Manage Your Asthma: Know Your Triggers and Treatment Options Asthma is a chronic lung disease that causes the airways to become inflamed and narrow. Not everyone with asthma has the same symptoms or can take the same medicine. Putting an action plan in place can help patients understand their asthma triggers and ensure they have the medications they need to reduce the number and severity of asthma attacks.

Participate in Upcoming FDA Meetings

Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee Meeting Announcement
December 17 – 18, 2018
FDA White Oak Campus, Silver Spring, MD