October 2019 Office of Women's Health e-Update
Message from the Acting Associate Commissioner
Dear Women’s Health Colleagues,
Throughout the month, the FDA Office of Women’s Health (OWH) will conduct multi-platform social media and partner outreach to educate women about the importance of mammography screening for early detection of breast cancer. Mammograms can help detect breast cancer when it is in its early, most treatable stages. Visit our mammography webpage for fact sheets and other resources to learn more and to help educate women about the importance of regular mammography screenings.
It is also a great time to raise awareness of FDA’s role in regulating mammography facilities. Since 1992, the FDA Mammography Quality Standards Act and Program has worked to ensure quality mammography throughout the U.S. FDA also supports research to better understand the safety and efficacy of medicines and devices used in breast cancer screening and treatment. Learn more about OWH-funded breast cancer and mammography research here.
Kaveeta Vasisht, M.D., Pharm.D.
Acting Associate Commissioner for Women's Health
Women's Health Highlights
FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels
The U.S. Food and Drug Administration approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid hormones). It is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s small blood vessels become inflamed, reducing the amount of blood that can flow through them. This can cause serious problems and damage to organs, most notably the lungs and the kidneys. It also can impact the sinuses and skin.
FDA approves treatment for adults and children with all genotypes of hepatitis C and compensated cirrhosis that shortens duration of treatment to eight weeks
The U.S. Food and Drug Administration expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection and compensated cirrhosis and have not been previously treated for HCV (treatment-naïve). Mavyret is now the first eight-week treatment approved for all treatment-naïve adult and certain pediatric patients with HCV genotypes 1-6 both without cirrhosis and with compensated cirrhosis. Standard treatment length for patients with compensated cirrhosis was previously 12 weeks or more.
Lung illnesses associated with use of vaping products
Both the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention are working tirelessly to investigate the distressing incidents of severe respiratory illness associated with use of vaping products. The FDA and CDC are working closely with state and local health officials to investigate these incidents as quickly as possible, and we are committed to taking appropriate actions as a clearer picture of the facts emerges.
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.
Statement from Acting Commissioner of Food and Drugs on FDA efforts to encourage patient engagement in medical device clinical investigations
At the U.S. Food and Drug Administration we are committed to keeping patients, their families and caregivers at the center of our work and to deepening their involvement in how we review medical device applications. We value patient experience and insights about living with a disease, like diabetes or end-stage renal disease, as well as any impact a medical device—such as a glucose monitor or hemodialysis system—has had in a patient’s diagnosis, treatment and management of that disease. Patient experiences and insight can help us understand the benefits most important to patients and what risks patients may or may not be willing to tolerate.
How medical devices are tested to determine a favorable benefit/risk profile is at the core of our medical device evaluations, and the patient voice provides important value in that process.
FDA approves first live, non-replicating vaccine to prevent smallpox and monkeypox
The U.S. Food and Drug Administration announced the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection. This is the only currently FDA-approved vaccine for the prevention of monkeypox disease.
FDA takes first action under new international collaboration with Australia and Canada designed to provide a framework for concurrent review of cancer therapies, approving treatment for patients with endometrial carcinoma
The U.S. Food and Drug Administration announced Project Orbis, an initiative of the FDA Oncology Center of Excellence (OCE). Project Orbis provides a framework for concurrent submission and review of oncology drugs among its international partners. Under this project, the FDA, the Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed applications for two oncology drugs, allowing for simultaneous decisions in all three countries.
FDA approves first oral GLP-1 treatment for type 2 diabetes
The U.S. Food and Drug Administration approves Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1) receptor protein treatment approved for use in the United States that does not need to be injected. GLP-1 drugs are non-insulin treatments for people with type 2 diabetes.
FDA announces voluntary recall of Sandoz ranitidine capsules following detection of an impurity
The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., used to decrease the amount of acid created by the stomach. This recall is due to a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer).
Call To Action
Help us to spread the word about the importance of mammograms!
On October 20, please join us in promoting our Pink Ribbon Sunday Program that helps to empower friends, family members, leaders and healthcare professionals to conduct mammography outreach activities for the women in their communities and practices.
Originally launched in 1991 targeting African American and Hispanic churches, the program has since expanded to local and national organizations serving women from diverse backgrounds.
Visit www.fda.gov/pinkribbon to download or order free mammography materials to share with the women in your church, organization, or community.
Wear something pink on October 20. It doesn't matter if you are going to church, yoga, brunch or a football game, show your support by wearing pink.
OWH Conferences and Exhibits
Women’s Health Annual Visit Series, 2019
October 11, 2019, New York, NY
NPWH 22nd Annual Premier Women's Healthcare Conference
October 16-19, 2019, Savannah, GA
Alaska Federation of Natives Convention 2019
October 17-19, 2019, Fairbanks, AK
Society for Neuroscience, Neuroscience 2019 Meeting
October 19 - 23, Chicago, IL
APHA Annual Meeting & Expo
November 2-6, 2019, Philadelphia, PA
Participate in Upcoming FDA Meetings
FDA Public Workshop: Partners in Progress 2019 - Cancer Patient Advocates and FDA
October 08, 2019
Vaccines and Related Biological Products Advisory Committee
October 09, 2019
Public Meeting on a New Era of Smarter Food Safety
October 21, 2019
Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee
October 30, 2019
FDA-MRA Approaches to Neoadjuvant Treatment in Melanoma: A Public Workshop
November 06, 2019