Message from the Associate Commissioner
Dear Women’s Health Colleagues,
FDA continues to work to help bridge gaps in representation in clinical trials. We understand that inclusion of women reflecting diversity in age, race, ethnic background and comorbid conditions should be at the forefront of these efforts. In our recent commentary, we underscore the importance of recruiting and retaining diverse populations in clinical trials. Over the years, participation of women in clinical trials has improved, and we are encouraged by the potential for new strategies to further this progress. OWH will continue to work with our federal partners and stakeholders to advance these efforts.
I am pleased to share the recording of our recent webinar with Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research. We discussed COVID-19 vaccines and their use in women in hopes of shedding light on questions you may have and to provide you with up to date information from FDA.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Below are links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
- FDA Takes Steps to Increase Availability of COVID-19 Vaccine
- Update: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests
- FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19
- Antibody Testing Is Not Currently Recommended to Assess Immunity After COVID-19 Vaccination: FDA Safety Communication
- FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents in Another Important Action in Fight Against Pandemic
CALL TO ACTION
This year, on National HIV Testing Day, we encourage you to know more about your status and encourage the women in your family and community to get tested on June 27th. The only way to know if you or someone has HIV is to get tested. Learn more about HIV testing and find a site near you here.
WOMEN'S HEALTH HIGHLIGHTS
Older Therapies Aren’t Necessarily Better for Thyroid Hormone Replacement
Millions of people have thyroid glands that don’t make enough thyroid hormone to meet their body’s needs. Hypothyroidism (underactive thyroid) is the most common reason some people need thyroid hormone replacement. Today, there are modern, synthetic (laboratory-made) medications approved by the FDA.
Viona Pharmaceuticals Inc., Issues Voluntary Nationwide Recall of Metformin HCl Extended-Release Tablets, USP 750 mg, Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity
Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits. This product was manufactured by Cadila Healthcare Limited, Ahmedabad, India in November 2019, for U.S. distribution by Viona Pharmaceuticals Inc.
FDA Grants Accelerated Approval for Alzheimer’s Drug
The U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.
FDA Approves New Drug Treatment for Chronic Weight Management, First Since 2014
The U.S. Food and Drug Administration approved Wegovy (semaglutide) injection (2.4 mg once weekly) for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced calorie diet and increased physical activity. This under-the-skin injection is the first approved drug for chronic weight management in adults with general obesity or overweight since 2014. The drug is indicated for chronic weight management in patients with a body mass index (BMI) of 27 kg/m2 or greater who have at least one weight-related ailment or in patients with a BMI of 30 kg/m2 or greater.
FDA Authorizes Marketing of Diagnostic Aid for Autism Spectrum Disorder
FDA authorized marketing of a device to help diagnose autism spectrum disorder (ASD). The Cognoa ASD Diagnosis Aid is a machine learning-based software intended to help health care providers diagnose ASD in children 18 months through 5 years of age who exhibit potential symptoms of the disorder.
FDA Approves First Targeted Therapy for Lung Cancer Mutation Previously Considered Resistant to Drug Therapy
FDA approved Lumakras (sotorasib) as the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation called KRAS G12C and who have received at least one prior systemic therapy. This is the first approved targeted therapy for tumors with any KRAS mutation, which accounts for approximately 25% of mutations in non-small cell lung cancers. KRAS G12C mutations represent about 13% of mutations in non-small cell lung cancers.
FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility
The U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: LeRoche Benicoeur/ConceiveEasy; EU Natural Inc.; Fertility Nutraceuticals LLC; SAL NATURE LLC/FertilHerb; and NS Products, Inc.
Watch Out for False Promises on Some Dietary Supplements
You may know someone who has been unable to get pregnant due to infertility issues. Marketers are targeting this population by pitching dietary supplements that make unproven claims to cure, treat, mitigate, or prevent infertility and other reproductive health conditions. These are not FDA-approved and could deter patients from seeking effective, FDA-approved products.
Mammography Problems at Advanced Women Imaging in Guttenberg, NJ - FDA Safety Communication
The FDA is alerting patients who had mammograms at Advanced Women Imaging, located in Guttenberg, NJ, on or after March 11, 2020, about possible problems with the quality of their mammograms.
Mammography Problems at Capitol Radiology, LLC, doing business as Laurel Radiology Services in Laurel, Maryland - FDA Safety Communication
FDA is alerting patients who had mammograms at Capitol Radiology, LLC, doing business as Laurel Radiology Services, located in Laurel, Maryland, on or after June 26, 2018, about possible problems with the quality of their mammograms.
Help the FDA Prevent the Sale of Tobacco Products to Young People
While overall smoking rates have declined over the years, youth tobacco use remains a concern. According to the National Youth Tobacco Survey, nearly 4.5 million youth used tobacco products in 2020, including nearly 3.6 million youth who used vaping products. It’s important to keep all tobacco products out of the hands of young people. Find out how you can help.
Magnets in Cell Phones and Smart Watches May Affect Pacemakers and Other Implanted Medical Devices
FDA is advising patients and caregivers to keep any consumer electronic devices, such as cell phones and smart watches, at least six inches away from implanted medical devices, such as pacemakers and defibrillators.
The FDA is aware that some newer consumer electronic devices including cell phones and smart watches have magnets that may cause some implanted medical devices to go into a magnetic safe mode and temporarily suspend normal operation. The magnetic safe mode allows for safe operation during certain medical procedures such as undergoing an MRI scan.
Update on Adverse Event Reports Associated with Essure
FDA remains committed to provide updates on the safety profile of Essure. Although Essure, a permanently implanted birth control device for women, has not been available for implantation in the U.S. since December 2019, the FDA continues to monitor the product’s safety through an FDA-required postmarket surveillance study and other activities.
On May 17, 2021, FDA provided an update on the ongoing postmarket evaluation of Essure. The update includes posting the ninth monthly spreadsheet of adverse event reports received by Bayer (the company that manufactured Essure) as required in the April 24, 2020, variance from Medical Device Reporting requirements. These events are from social media in connection with litigation, may reference information already reported to the FDA, and do not necessarily represent new adverse events.
Medication Errors Happen to Pets, Too
Your dog or cat is sick, and you head to the animal hospital. The veterinarian prescribes medications that you hope will make your pet better. But with pets, as with people, medication errors can happen. Just as the Food and Drug Administration monitors medication errors that affect people, the agency watches out for mistakes that may harm animals.
Pregnancy exposure registries are studies that collect health information on exposure to medical products such as drugs and vaccines during pregnancy.
Learn more about pregnancy registries today!
Participate in Upcoming FDA Meetings
- FDA Oncology Center of Excellence: Conversations on Cancer: “National Black Family Cancer Awareness Week: Engaging the Generations” #BlackFamCan, June 17, 2021
- FDA-Arthritis Foundation Osteoarthritis Drug Development Workshop: Assessment of Long-term Benefit, June 22, 2021
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.