Women's Health Update - August 2018

www.fda.gov/womens

August 2018

Message from the Director

OWH continues to advance scientific and outreach initiatives that impact women and their families. Opioid and nicotine use, dependence, and recovery are vital issues that have affected the lives of many. Therefore, it is imperative that these issues be examined with a sex and gender lens. Opioid use disorder is not only increasing at alarming rates, but the prevalence of prescription opioid and heroin use among women is substantial; with women appearing to progress more quickly to addiction than men. Simultaneously, smoking continues to have a profound impact on the health and well-being of women and their families. Another addictive behavior is smoking which can cause coronary heart disease, cancer, and stroke—the first, second, and fourth leading causes of death for women in the United States. Given these facts, OWH will be hosting a two-day scientific conference, “Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender” on September 27 and 28, 2018 to discuss sex and gender influences on opioid and tobacco use, misuse, and cessation with researchers, clinicians, and policy experts. We are honored to have keynote speeches by FDA Commissioner Scott Gottlieb and the U.S. Surgeon General, VADM Jerome M. Adams, M.D., M.P.H. I encourage you and your networks to join us via webcast for this important discussion. In this update, you will also find resources for back to school planning and other recent FDA communications that affect women across the lifespan.   Marsha Henderson, Associate Commissioner for Women's Health

Register Today: Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender Scientific Conference Join the FDA Office of Women’s Health, in collaboration with the Center for Drug Evaluation and Research and Center for Tobacco Products, for a conference on Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender. This public meeting will be held on September 27 and 28, 8:30 AM – 4:00 PM, FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503-A), Silver Spring, MD 20993. Register to view the webcast: https://go.usa.gov/xUk8P If you have questions about the conference, please email to OWH_OandNConf@fda.hhs.gov Statement from FDA Commissioner Scott Gottlieb, M.D., on manufacturer announcement to halt Essure sales in the U.S. The U.S. Food and Drug Administration was notified by Bayer that the Essure permanent birth control device will no longer be sold or distributed after December 31, 2018. This decision follows the FDA’s patient safety action in April, in which the agency issued an order restricting the sale and distribution of Essure; it was a unique type of restriction where the FDA used its authority to impose additional requirements to provide a reasonable assurance of the device’s safety and effectiveness. Read the full FDA Statement Learn more about FDA Activities: Essure FDA alerts healthcare providers, women about risks associated with improper use of rupture of membranes tests The U.S. Food and Drug Administration alerted women and their doctors about serious adverse events related to the improper use of tests intended as an aid in detecting if a pregnant woman’s water has broken (also known as a rupture of the membranes containing amniotic fluid). A rupture of the membranes (ROM) can pose immediate and severe risks to the patient and developing fetus without proper patient management and timely intervention. Read the FDA News Release Read the MedWatch Safety Alert FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures We are aware that certain device manufacturers may be marketing their energy-based medical device for vaginal "rejuvenation" and/or cosmetic vaginal procedures. The safety and effectiveness of energy-based medical devices to perform these procedures has not been established. Read the FDA Safety Communication Read the Statement from FDA Commissioner Scott Gottlieb, M.D., on efforts to safeguard women’s health from deceptive health claims and significant risks related to devices marketed for use in medical procedures for “vaginal rejuvenation”   FDA takes new steps to encourage the development of novel medicines for the treatment of opioid use disorder The U.S. Food and Drug Administration issued new scientific recommendations aimed at encouraging more widespread innovation and development of novel medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). New draft guidance issued outlines new ways for drug developers to consider measuring and demonstrating the effectiveness and benefits of new or existing MAT products. This new draft guidance is part of the FDA’s ongoing commitment to promote more widespread development, access to and adoption of MAT. Read the FDA News Release. FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer The U.S. Food and Drug Administration approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System (Sentimag System) uses magnetic detection during sentinel lymph node biopsy procedures to identify specific lymph nodes, known as sentinel lymph nodes, for surgical removal. Read the FDA News Release. FDA Unveils New Tobacco Regulatory Efforts FDA Commissioner Scott Gottlieb, M.D., and CTP Director Mitch Zeller co-authored “Advancing Tobacco Regulation to Protect Children and Families: Updates and New Initiatives from the FDA on the Anniversary of the Tobacco Control Act and FDA’s Comprehensive Plan for Nicotine,” a new post on the FDA Voice blog. Read “Advancing Tobacco Regulation to Protect Children and Families" Read FDA’s Comprehensive Plan for Nicotine and Tobacco Regulation FDA Releases Biosimilars Action Plan The FDA is committed to encouraging innovation and competition among biologics and the development of biosimilars. Read the key actions FDA is taking to encourage innovation and competition among biologics and the development of biosimilars. Read the Biosimilars Action Plan: Balancing Innovation and Competition

Back To School Resources FDA has resources to prepare college students, teens, and young children for a safe and healthy school year. College Women’s Health Webpage Medication Safety Tips for Parents and Caregivers Vaccines for Children: A Guide for Parents and Caregivers

Participate in Upcoming FDA Meetings

Public Meeting - Pediatric Medical Device Development August 13 - 14, 2018, 9:00 am to 5:00 pm FDA White Oak Campus, Silver Spring, MD FDA Public Workshop: Development of Non-Traditional Therapies for Bacterial Infections. August 21, 2018, 8:30 am to 4:30 pm August 22, 2018, 8:30 am to 12:00 pm FDA White Oak Campus, Silver Spring, MD FDA - AACR Workshop: Non-Clinical Models for Safety Assessment of Immuno-Oncology Products September 6, 2018, 8:00 am to 5:00 pm Marriott Wardman Park Hotel, Washington, DC Human Dermal (Skin) Safety Testing for Topical Drug Products: Regulatory Utility and Evaluation; Public Workshop September 10, 2018, 8:30 am to 4:00 pm FDA White Oak Campus, Silver Spring, MD Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery: Influences of Sex and Gender September 27 – 28, 2018, 8:30 am to 4:00 pm FDA White Oak Campus, Silver Spring, MD Visit an OWH exhibit booth or presentation at these upcoming conferences. American Association of Diabetes Educators (AADE) August 17 – 20, 2018, Baltimore, MD National Association of Community Health Centers – Community Health Institute August 24 – 28, 2018, Orlando, FL The United States Conference on AIDS (USCA2018) September 6 – 9, 2018, Orlando, FL Learn more about OWH staff presentations at national and international meetings and conferences.