Women's Health Update - July 2018

Message from the Director

It is with deep appreciation that I announce the retirement of Dr. Pamela Scott and to celebrate her 32 years of federal service. She has had a long and distinguished career here at FDA. For 28 years, she has excelled as a statistician and epidemiologist serving in FDA’s Center for Drug Evaluation and Research (CDER), Center for Devices and Radiological Health (CDRH), and the Office of Women’s Health. While in CDER, Dr. Scott worked to improve the collection and evaluation of data on drug exposure during pregnancy and birth outcomes. Dr. Scott served as FDA Program Director and Chairperson of the Steering Committee for the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP), an FDA-funded initiative developed to conduct epidemiological studies of the risk of drug exposure during pregnancy and birth outcomes across 11 participating health plans within 9 states. FDA and other government agencies use MEPREP to evaluate medical product safety for pregnant women. Dr. Scott returned to the Office of Women’s Health to become the Deputy Director and leader of the Research and Development Team. Her timing was perfect. The Agency had a new Congressional Mandate, FDASIA Section 907, which required FDA to evaluate the participation of demographic groups in clinical trials and subset analyses that support applications for new drugs, biologics, and devices. She chaired the agency-wide workgroup that designed, collected, and analyzed these data for submission to Congress. This data report, provided the foundation for the FDA Action Plan to Enhance the Collection and Availability of Subgroup Data, which reflects the Agency’s commitment to encourage the inclusion and greater representation of a diverse patient population in biomedical research leading to the development of medical products. Dr. Scott continued to work collaboratively across FDA on projects examining the inclusion of women in clinical trials in areas of concerns for Congress, such as cardiovascular disease, resulting in FDA presenting a clear and accurate picture of the progress made in demographic inclusion and identifying areas of improvement. Her reputation for excellence gained continued momentum when she revived the OWH Research Steering Committee to help implement the OWH Research Roadmap, which established seven key priority areas of focus for women’s health research. This Research Roadmap became the template for all FDA Centers and Offices seeking OWH intramural grant funds. For the first time, OWH has a cross-agency collaboratively developed blueprint for women’s health regulatory research. Throughout her FDA career, Dr. Scott has spear headed efforts to improve the health of women. Dr. Scott is a graduate of Frostburg State University with a dual degree in Mathematics and Psychology. She earned a master’s degree in Statistics from American University and later returned to the classroom to earn a Ph.D. in Epidemiology, with a concentration in Clinical Trials Methodology, from the Johns Hopkins Bloomberg School of Public Health. Dr. Scott’s dedication, hard work, and technical expertise have been critical to the advancement of our operations. We have valued her insight and exceptional leadership, as well as her work to develop and implement a wide array of cross-cutting strategic initiatives. I hope you will join me in celebrating her retirement.   Marsha Henderson, Associate Commissioner for Women's Health

FDA approves first generic versions of Suboxone sublingual film, which may increase access to treatment for opioid dependence The U.S. Food and Drug Administration approved the first generic versions of Suboxone (buprenorphine and naloxone) sublingual film (applied under the tongue) for the treatment of opioid dependence. “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access,” said FDA Commissioner Scott Gottlieb, M.D. Read the FDA News Release. FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome. Read the FDA News Release. Learn more about FDA and marijuana. FDA announces revised guidance on the testing of donated blood and blood components for Zika virus The FDA announced the availability of a revised final guidance: “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components.” This revised guidance replaces the August 2016 guidance, which recommended universal nucleic acid testing for Zika virus of individual units of blood donated in the U.S. states and territories. Read the FDA In Brief. FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes The U.S. Food and Drug Administration approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days. Read the FDA News Release. Visit the Women and Diabetes webpage. Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s efforts to better equip consumers with nutritional information about dietary fiber in their food FDA issued guidance recognizing 8 additional fibers to be counted as fiber on the Nutrition Facts label; evidence shows they have beneficial health effects. Read the FDA Statement.

Get the Facts on Tampons—and How to Use Them Safely If you use tampons during your period (also called a “menstrual cycle”), it’s important to know the basics for how to use them safely. Consider this important information from the U.S. Food and Drug Administration—and please share it with friends and loved ones who may use these products. Read the Consumer Update. Put Safety First This Summer  FDA has resources to help you and your family stay healthy this summer. Read and share these top summer safety tips with your community. 5 Tips for a Healthy Vacation Sunscreen: How to Help Protect Your Skin from the Sun Food Safety for Moms to Be: Summer Fun Ticks and Lyme Disease: Symptoms, Treatment, and Prevention Looking for summer safety tips on social media? Follow @FDAWomen on Twitter and Pinterest.

Participate in Upcoming FDA Meetings

Blood Products Advisory Committee Meeting July 18, 2018, 8:00 am to 5:00 pm July 19, 2018, 8:00 am to 3:00 pm FDA White Oak Campus, Silver Spring, MD Meeting of the Pulmonary-Allergy Drugs Advisory Committee Meeting  July 25, 2018, 8:00 am to 5:00 pm FDA White Oak Campus, Silver Spring, MD Antimicrobial Drugs Advisory Committee Meeting July 26, 2018, 8:30 am to 4:00 pm FDA White Oak Campus, Silver Spring, MD FDA Grand Rounds: How Simulation Can Transform Regulatory Pathways August 9, 2018, 12:00pm to 1:00 pm Webcast Visit an OWH exhibit booth or presentation at these upcoming conferences. Teratology Society: 57th Annual Meeting July 10 – 13, 2018, New Orleans, LA 109th NAACP Annual Convention July 14 – 18,2018, San Antonio, TX Healthy Aging Summit July 16 – 17, 2018, Washington, DC National Association of Area Agencies on Aging (N4a) July 29 – August 1, 2018, Chicago, IL National Black Nurses Association July 31 – August 5, 2018, St. Louis, MO Learn more about OWH staff presentations at national and international meetings and conferences