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August 2018 Office of Women's Health e-Update

August 2018 Office of Women's Health e-Update

Image of smoke and opioid pills

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 and other recent FDA communications that affect women across the lifespan.

Marsha Henderson, Associate Commissioner for Women's Health

Women's Health Highlights

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.

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.

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.

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.

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.

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.

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.

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.

Call To Action

Back To School Resources

FDA has resources to prepare college students, teens, and young children for a safe and healthy school year.

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.