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September 2019 Office of Women's Health e-Update

Smiling female college student in foreground, group of students on campus in background

Message from the Acting Associate Commissioner

Dear Women’s Health Colleagues,

Back-to-school season is here. For many women who are entering college, this may be the first time they are managing their own personal health needs. It is important to remember to prioritize health and wellness when starting off the school year. FDA has valuable health and safety resources for college women. I encourage you to learn more about our health tips and OWH’s College Women’s Campaign at www.fda.gov/collegewomen. Be sure to remind your friends, family members, or classmates to get their annual wellness exams, stay up-to-date on vaccines and prescriptions, and make healthy choices.  

As we transition to fall, we are excited to announce OWH’s next scientific seminar on October 10, 2019. Dr. Londa Schiebinger, Stanford University Professor and Director of Global Gendered Innovations in Science, Health & Medicine, and Engineering will discuss ways to harness the creative power of gender analysis for discovery and innovation. OWH strives to bring in world-renowned experts on cross-cutting topics to inform FDA staff on important sex and gender considerations to enhance the regulatory process and advance the health of women. 

Sincerely,

Kaveeta Vasisht, M.D., Pharm.D.
Acting Associate Commissioner for Women's Health

Women's Health Highlights

Vaping Illnesses: Consumers can help protect themselves by avoiding tetrahydrocannabinol (THC)-containing vaping products
Consumers are likely aware of the recent reports of respiratory illnesses — including some resulting in deaths – following the use of vaping products. The U.S. Food and Drug Administration remains deeply concerned about these incidents and is working closely with the U.S. Centers for Disease Control and Prevention, as well as state and local public health partners to investigate them as quickly as possible.

While the work by federal and state health officials to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA is providing consumers with some information to help protect themselves.

FDA reiterates the importance of vaccines such as the Measles, Mumps, and Rubella (MMR) vaccine
The U.S. continues to experience cases and outbreaks of measles, largely due to unvaccinated or under-vaccinated segments of the population. Measles can be a serious disease. This year has seen the greatest number of measles cases reported in the U.S. since 1992, and since measles was declared eliminated in 2000. Of those diagnosed with measles, approximately 10% have required hospitalization. The majority of cases are among people who were not vaccinated. The Measles, Mumps, and Rubella (MMR) vaccine has been approved in the U.S. for nearly 50 years. It is highly effective and very safe. As a result of its use, measles was declared eliminated in the U.S. in 2000, rubella in 2004, and since 1989.

FDA solicits public feedback on discussion paper as part of efforts to provide clarity and transparency on how it evaluates benefits and risks of weight-loss devices 
The U.S. Food and Drug Administration issued a discussion paper on assessing risk for weight-loss devices with varying degrees of benefits. The FDA has actively engaged stakeholders regarding how we can best ensure patients have access to safe and effective devices intended for weight loss.

FDA warns patients and health care professionals about rare instances of serious liver injury or failure with certain hepatitis C treatments in some patients with advanced liver disease
The U.S. Food and Drug Administration has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic hepatitis C (HCV) in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure. These medicines are not indicated for use in patients with moderate to severe liver impairment but are safe and effective in patients with no or mild liver impairment. Through reports submitted to the FDA as well as other sources, the agency identified 63 cases of worsening liver function, called decompensation, some leading to liver failure or death, in patients using Mavyret, Zepatier and Vosevi. In many of the reported cases, liver failure occurred in patients who had signs and symptoms of moderate-to-severe liver disease or other serious liver problems and should not have been treated with these medicines.

FDA’s Center for Tobacco Products: 10 years of tobacco regulatory science and research
In 2009, FDA’s Center for Tobacco Products was formed with the mission to reduce disease and death from tobacco use through science-based regulation. And science is the foundation of all that we do.

FDA regulates products in a complex and changing tobacco landscape, one where products reside on a continuum of risk with deadly combustible products on one end and effective medicines and treatments on the other. New and novel products have entered the marketplace over the last decade, many with unknown longer-term effects on the overall, population-level health of U.S. residents. 

Up to 587,000 youth prevented from trying cigarettes by FDA’s “The Real Cost” campaign
New analysis of FDA’s award-winning public health education campaign, “The Real Cost,” shows the campaign continues to influence youth behaviors towards cigarette smoking. Between Feb. 2014 and Nov. 2016, “The Real Cost” prevented up to 587,000 youth from trying cigarettes, half of whom might have gone on to become established adult smokers.

FDA encourages inclusion of male patients in breast cancer clinical trials 
The draft guidance, Male Breast Cancer: Developing Drugs for Treatment, includes draft recommendations for inclusion of males in breast cancer clinical trials. Historically, males either have not been included in clinical trials for drugs to treat breast cancer or inclusion of males in those trials has been very limited; when finalized, the draft guidance will provide clarity for industry regarding clinical development of drugs to treat breast cancer in male patients.

FDA approves new device to improve symptoms in patients with advanced heart failure
The U.S. Food and Drug Administration approved the Barostim Neo System for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronization therapy. 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.

“Patients with advanced heart failure have limitations of physical activity, experiencing fatigue, palpitation or shortness of breath with activity and may not benefit from standard treatments, including currently marketed drugs and devices. This approval provides patients with a new treatment option for the symptoms associated with advanced heart failure,” said Bram Zuckerman, M.D., director of the Office of Cardiovascular Devices in the FDA’s Center for Devices and Radiological Health.

FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
The U.S. Food and Drug Administration granted accelerated approval to Rozlytrek (entrectinib), a treatment for adult and adolescent patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. “We are in an exciting era of innovation in cancer treatment as we continue to see development in tissue agnostic therapies, which have the potential to transform cancer treatment. We’re seeing continued advances in the use of biomarkers to guide drug development and the more targeted delivery of medicine,” said FDA Acting Commissioner Ned Sharpless, M.D. “Using the FDA’s expedited review pathways, including breakthrough therapy designation and accelerated approval process, we’re supporting this innovation in precision oncology drug development and the evolution of more targeted and effective treatments for cancer patients. We remain committed to encouraging the advancement of more targeted innovations in oncology treatment and across disease types based on our growing understanding of the underlying biology of diseases.”

FDA approves new antibiotic to treat community-acquired bacterial pneumonia
The U.S. Food and Drug Administration approved Xenleta (lefamulin) to treat adults with community-acquired bacterial pneumonia.

“This new drug provides another option for the treatment of patients with community-acquired bacterial pneumonia, a serious disease,” said Ed Cox, M.D., M.P.H., director of FDA’s Office of Antimicrobial Products. “For managing this serious disease, it is important for physicians and patients to have treatment options. This approval reinforces our ongoing commitment to address treatment of infectious diseases by facilitating the development of new antibiotics.”

Community-acquired pneumonia occurs when someone develops pneumonia in the community (not in a hospital). Pneumonia is a type of lung infection that can range in severity from mild to severe illness and can affect people of all ages. According to data from the Centers from Disease Control and Prevention, each year in the United States, about one million people are hospitalized with community-acquired pneumonia and 50,000 people die from the disease.

FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy
The U.S. Food and Drug Administration has warned Stemell, Inc. (Stemell), of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, Ph.D., for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices and environmental monitoring, creating potential significant safety concerns that put patients at risk. Stemell’s unapproved products derived from umbilical cord blood and umbilical cord are StemL UCB-Plus and StemL UCT-Plus.

Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Deputy Commissioner Frank Yiannas calling on all sectors of the papaya industry to improve practices to better protect consumers
Every day Americans enjoy an abundant food supply that is among the safest in the world. The U.S. Food and Drug Administration works tirelessly to ensure that foods available to consumers, whether they are produced domestically or abroad, meet the FDA’s food safety requirements and that we are using all available tools to ensure compliance.

As demand and tastes continue to drive change in the market, consumers’ desire for a variety of products available year-round have increased the number of imported foods offered for sale in the U.S. To keep up with this trend, we have doubled down on our efforts to ensure the safety of imported food. This includes issuing a new Strategy for the Safety of Imported Food and requesting new funding from Congress to support our efforts.

While we continue to focus on shifting our work upholding food safety from response to prevention, we know that there are times where we will still need to respond to problems when they arise, including outbreaks of foodborne illness. This is especially important when we see recurrent patterns of illness associated with particular commodities. For example, fresh papayas.

Call To Action

Do you know a college student, leader, or administrator who might be interested in the 2019 OWH College Women’s Campaign social media toolkit that provides FDA health and safety information for students? Please share our downloadable social media toolkit with them today! 

Meetings

OWH Conference Exhibits

The North American Menopause Society 2019 Annual Meeting
Chicago, IL, September 25-28, 2019

2019 Alaska Federation of Natives Convention
Fairbanks, AK, October 14-20, 2019

Nurse Practitioner in Women’s Health 22nd Annual Premier Women’s Healthcare Conference
Savannah, GA, October 16-19, 2019

Participate in Upcoming FDA Meetings

Identification and Use of Biomarkers to Advance Development of Preventive Vaccines; Public Workshop
September 16-17, 2019

Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing
September 17, 2019

Meeting of the Nonprescription Drugs Advisory Committee
September 18, 2019

Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees
September 26, 2019

Meeting of the Pediatric and Drug Safety and Risk Management Advisory Committees
September 27, 2019

Public Meeting on Horizontal Approaches to Food Standards of Identity Modernization
September 27, 2019

Accelerating Drug Development for Polyarticular Juvenile Idiopathic Arthritis (pJIA)
October 2, 2019

Developing Real-World Data and Evidence to Support Regulatory Decision-Making
October 3, 2019

FDA Public Workshop: Partners in Progress 2019 - Cancer Patient Advocates and FDA
October 8, 2019

Vaccines and Related Biological Products Advisory Committee Meeting
October 9, 2019