December 2020 Office of Women's Health e-Update
Message from the Associate Commissioner
Dear Women’s Health Colleagues,
This month, FDA issued emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The Agency is committed to providing timely recommendations, regulatory information, guidance, and technical assistance to support rapid COVID-19 response efforts. This year, to further advance our understanding of COVID-19, we convened several scientific seminars bringing in world renowned experts to discuss the emerging science with FDA staff and our federal partners on topics including Sex Differences and Vaccines, COVID-19 and Pregnancy, and Sex Differences in COVID-19. Learn more about FDA’s COVID-19 response below.
As 2020 comes to an end, I encourage you to explore the resources available under our Knowledge and News on Women’s Health (KNOWH) initiative; such as our educational video focused on women and heart disease and the OWH blog. In addition, we partnered with the National Institutes of Health Office of Research on Women’s Health (ORWH) to develop Bench to Bedside: Integrating Sex and Gender to Improve Human Health, a six module educational e-learning series, developed in to explore sex- and gender-related differences in key disease areas.
Last month, we held a widely attended scientific conference on sex and gender differences in use and response to CBD and other cannabinoids. Presentations addressed patient and healthcare provider perspectives, sex differences in the effects of CBD and other cannabinoids, use of CBD and other cannabinoids in pregnancy, and government agency perspectives on CBD research and evaluation. This conference underscores our dedication to considering sex and gender in emerging public health issues. The meeting program and recording can be accessed here.
We thank you for your support during this past year and look forward to connecting with you in the New Year.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
WOMEN'S HEALTH HIGHLIGHTS
FDA Warns Companies Illegally Selling CBD Products
Today, the U.S. Food and Drug Administration issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). All five warning letters address the illegal marketing of unapproved CBD products claiming to treat medical conditions. The warning letters include CBD products that are especially concerning from a public health perspective due to the route of administration, including nasal, ophthalmic and inhalation. In addition, they address violations relating to the addition of CBD to food, and the impermissible marketing of CBD products as dietary supplements. Two of the letters also address CBD products illegally marketed for pets, including a product for use in the eye.
FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.
FDA Approves First Oral Hormone Therapy for Treating Advanced Prostate Cancer
The U.S. Food and Drug Administration approved Orgovyx (relugolix) for the treatment of adult patients with advanced prostate cancer.
FDA Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients
The U.S. Food and Drug Administration is warning consumers not to use nearly 50 male enhancement or weight loss products that have been found to contain hidden ingredients and may pose a significant health risk. The FDA purchased these products on Amazon and eBay and agency testing found that the products contain active pharmaceutical ingredients not listed on their labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking.
WishGarden Herbs Issues Voluntary Nationwide Recall of Cord Care and Goldenseal Powder Due to Bacterial Contamination
WishGarden Herbs, Inc. is voluntarily recalling, to the consumer level, 14 lots of Cord Care and Goldenseal Powder products produced after 7/26/18 with expiration dates between 7/26/18 and 9/1/20. After receiving notice of a supply chain issue, WishGarden has determined these products were manufactured using ingredients potentially contaminated with Cronobacter sakazakii bacteria. Use of these products, when contaminated with this bacteria, may cause serious infections with severe outcomes, including death, especially in vulnerable patients with compromised immune systems and infants.
The FDA Provides An Update on Essure
The U.S. Food and Drug Administration (FDA) continues to monitor the safety profile of Essure, a permanently implanted birth control device for women, through an FDA-required postmarket surveillance study and other activities. Since December 2019, Essure is not available for implantation in the U.S. The FDA is providing an update on ongoing postmarket activities for women who received the Essure implant.
FDA Expands Approval of Influenza Treatment to Post-Exposure Prevention
The U.S. Food and Drug Administration expanded the approved indication for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza (flu) for patients 12 years of age and older after contact with an individual who has the flu. Xofluza, previously available only in tablet form, is also now available as granules for mixing in water. Xofluza was originally approved in 2018 for treating uncomplicated flu in patients 12 years of age and older who have been symptomatic for no more than 48 hours.
FDA Releases New Videos on Patient Engagement and Medical Devices
The U.S. Food and Drug Administration (FDA) released three new videos highlighting patients’ experiences in partnering with the FDA and how patient input enhances the agency’s ability to evaluate medical devices and monitor their safety. In these short videos, patients share their experiences partnering with CDRH as well as the impact their input has on enhancing CDRH’s ability to evaluate medical devices and monitor their safety.
FDA grants accelerated approval to pembrolizumab for locally recurrent unresectable or metastatic triple negative breast cancer
On November 13, 2020, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test.
FDA also approved the PD-L1 IHC 22C3 pharmDx (Dako North America, Inc.) as a companion diagnostic for selecting patients with TNBC for pembrolizumab.
Protect Your Family From Fraudulent Flu Products
The fall and winter flu season may bring out dishonest sellers hawking fraudulent products to unsuspecting consumers, who are already concerned about protecting themselves from coronavirus disease 2019 (COVID-19) and other infectious diseases.
Some of these sellers offer unproven products that claim to prevent, mitigate, treat, or cure the flu even though they have not been evaluated or approved by the U.S. Food and Drug Administration (FDA) for safety and effectiveness. These products might be dangerous to you and your family. The FDA urges consumers to avoid fraudulent flu products and offers some tips on how to spot them.
CALL TO ACTION
HIV/AIDS Awareness Month is a time when we remember and honor those that continue to fight this health epidemic and show support for people living with the disease while also commemorating those that have died from HIV. It’s also a time to stress the importance of HIV prevention, testing, and treatment. Although HIV diagnoses among women have declined in recent years, more than 7,000 women received an HIV diagnosis in the United States and dependent areas in 2018 (CDC). This is why it remains important for you to know your HIV status. The only way to know for sure is to get an HIV test. To find a testing site near you, call 1-800-232-4636, or text your zip code to KNOWIT (566948).
Our office has resources to help you learn more about women and HIV, HIV testing, prevention, and treatment. Our HIV and AIDS: Medicines to Help You guide provides information about FDA-approved medicines to treat HIV, facts about HIV, and important questions to ask your healthcare provider about treatment, including if you are pregnant or breastfeeding. Working Together, we can help stop HIV by getting the facts, getting tested, getting treatment, and getting involved!
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
Public Meeting on Patient-Focused Drug Development for Vitiligo - March 8, 2021
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.