Message from the Associate Commissioner
Dear Women’s Health Colleagues,
As we face the unprecedented global impact of the coronavirus disease 2019 (COVID-19), the FDA is working tirelessly with federal partners, including the Centers for Disease Control and Prevention (CDC), medical product developers, and international partners to address this pandemic. The Agency is committed to providing timely recommendations, regulatory information, guidance, and technical assistance to support rapid COVID-19 response efforts.
We are sharing numerous FDA resources and updates and a catalog of U.S. Government activities related to COVID-19 that can be accessed here. I encourage you to follow the guidance provided by experts, specifically information curated by the COVID-19 Task Force (www.coronavirus.gov) and our partners at CDC. More information can be found below. In addition, we have updated our Office of Women’s Health webpage to highlight resources specific to women. Please continue to do your part to help slow the spread of the virus and know that we remain steadfastly committed to our vital public health mission.
Kaveeta Vasisht, M.D., Pharm.D.
Associate Commissioner for Women's Health
Director, Office of Women's Health
Coronavirus (COVID-19) Update: FDA expedites review of diagnostic tests to combat COVID-19
The U.S. Food and Drug Administration has been providing unprecedented flexibility to labs and manufacturers to develop and offer COVID-19 tests across the U.S. The FDA’s regulations have not hindered or been a roadblock to the rollout of tests during this pandemic. Every action the FDA has taken during this public health emergency to address the COVID-19 pandemic has balanced the urgent need to make diagnostic tests available with providing a level of oversight that ensures accurate tests are being deployed. Moreover, as in previous emergencies, the FDA has been extremely proactive and supportive of test development by all comers—laboratories, and large and small commercial manufacturers—offering our expertise and support to speed development and to quickly authorize tests that the science supports.
Below are additional links to specific COVID-19 topics, with a full list of the latest COVID-19 information from the FDA here.
- FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation
- Safely Using Hand Sanitizer
- Coronavirus (COVID-19) Update: FDA takes further steps to help mitigate supply interruptions of food and medical products
- Coronavirus (COVID-19) Update: FDA takes action to help increase U.S. supply of ventilators and respirators for protection of health care workers, patients
- Food Safety and Availability During the Coronavirus Pandemic
- Beware of Fraudulent Coronavirus Tests, Vaccines and Treatments
- FDA advises patients on use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19
- Coronavirus (COVID-19) Update: FDA issues a guidance on conducting clinical trials
CALL TO ACTION
Taking care of yourself is the first step towards good health and being able to take care of the ones you love. In recognition of National Minority Health Month, the FDA Office of Women’s Health (OWH) encourages you to take charge of your health by learning more about diseases and health conditions to help you make health decisions for you, your family and community. OWH has resources on health topics such as diabetes and medicines to treat diabetes, medicines to treat depression, and what you should know about women and heart health, HIV, HPV and pain medicines.
Visit OWH at www.fda.gov/womens to check out FDA safety and health information and our women's health resources, publications and healthy living tips. You can download or order free copies of our publications in English, Spanish and several other languages at www.fda.gov/womenshealthpubs.
WOMEN’S HEALTH HIGHLIGHTS
FDA Requests Removal of All Ranitidine Products (Zantac) from the Market
The U.S. Food and Drug Administration announced it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications (commonly known by the brand name Zantac). The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S.
FDA Launches New Campaign to Help Consumers Use the New Nutrition Facts Label
The U.S. Food and Drug Administration launched an initiative to help consumers use the new Nutrition Facts label that appears on packaged foods to maintain healthy dietary practices. The campaign with the tagline “What’s In It For You?” aims to reach the general public and also focuses on consumers at increased risk of nutrition-related chronic diseases, including obesity. The campaign includes videos and educational materials of “food products” modeling their new looks, including on a fashion runway, after receiving a makeover.
FDA Proposes Broad Approach for Conducting Safety Trials for Type 2 Diabetes Medications
The U.S. Food and Drug Administration issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” to solicit public comment on its proposals for broad safety evaluations before drug approval that look beyond ischemic (reduced blood flow) cardiovascular disease, as well as for the inclusion of a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects.
FDA Releases Final Report of Talc-containing Cosmetic Products Tested for Asbestos
“The FDA is committed to keeping consumers safe from potentially contaminated cosmetic products. As part of this effort, in September 2018, the agency awarded AMA Analytical Services, Inc. (AMA) a one-year contract to test certain talc-containing cosmetic products for the presence of asbestos. We have taken and will continue to take swift action when we determine a cosmetic product is not safe. There is general agreement among U.S. federal agencies and the World Health Organization that there is no known safe level of asbestos exposure.”
FDA Makes Available Results from Testing of Infant Rice Cereal for Inorganic Arsenic
The U.S. Food and Drug Administration (FDA) is making available results from our most recent testing of infant rice cereals for inorganic arsenic. These results show that manufacturers have made significant progress in reducing levels of inorganic arsenic in these products. In 2018, the FDA collected and tested 149 infant rice cereals following the release of the agency’s 2016 Draft Guidance for Industry which proposed an action level of 100 parts per billion (ppb) for inorganic arsenic in infant rice cereals.
FDA Approves New Treatment for Pediatric Patients with Any Strain of Hepatitis C
The U.S. Food and Drug Administration approved a supplemental application for Epclusa (sofosbuvir and velpatasvir) to treat hepatitis C virus (HCV) in children ages 6 years and older or weighing at least 37 pounds (17 kilograms) with any of the six HCV genotypes—or strains—without cirrhosis (liver disease) or with mild cirrhosis. Epclusa in combination with ribavirin is indicated for the treatment of pediatric patients 6 years and older or weighing at least 37 pounds with severe cirrhosis. The FDA previously approved Epclusa to treat HCV in adults.
“This approval will provide additional treatment options for children and adolescents with HCV,” said Debra Birnkrant, M.D., director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research. “This approval will also be important in settings where there is limited ability for health care professionals to conduct HCV genotype testing.”
FDA Requires New Health Warnings for Cigarette Packages and Advertisements
The U.S. Food and Drug Administration issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements. The warnings feature textual statements with photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more.
“The 11 finalized cigarette health warnings represent the most significant change to cigarette labels in more than 35 years and will considerably increase public awareness of lesser-known, but serious negative health consequences of cigarette smoking,” said Mitch Zeller, J.D., director of FDA’s Center for Tobacco Products. “Research shows that the current warnings on cigarettes, which have not changed since 1984, have become virtually invisible to both smokers and nonsmokers, in part because of their small size, location and lack of an image. Additionally, research shows substantial gaps remain in the public’s knowledge of the harms of cigarette smoking, and smokers have misinformation about cigarettes and their negative health effects. The new cigarette health warnings complement other critical FDA actions, including outreach campaigns targeted to both adults and youth, to educate the public about the dangers associated with using cigarettes, as well as other tobacco products.”
FDA Alerts Patients and Health Care professionals of EpiPen Auto-injector Errors Related to Device Malfunctions and User Administration
FDA is alerting patients, caregivers and health care professionals that EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to:
- Device failure from spontaneous activation caused by using sideways force to remove the blue safety release;
- Device failure from inadvertent or spontaneous activation due to a raised blue safety release;
- Difficulty removing the device from the carrier tube;
- User errors.
- Learn More about Safety Alert
Insulin Gains New Pathway to Increased Competition
March 23, 2020 was a historic day and a landmark moment for patients with diabetes and other serious medical conditions, as insulin and certain other biologic drugs transition to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, is incredibly important for patients. For the first time, a pathway will be open for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies.
Fecal Microbiota for Transplantation: Safety Alert - Risk of Serious Adverse Events Likely Due to Transmission of Pathogenic Organisms
FDA is informing health care providers and patients of the potential risk of serious or life-threatening infections with the use of fecal microbiota for transplantation (FMT). The FDA is now aware of infections caused by enteropathogenic Escherichia coli (EPEC) and Shigatoxin-producing Escherichia coli (STEC) that have occurred following investigational use of FMT that it suspects are due to transmission of these pathogenic organisms from FMT product supplied by a stool bank company based in the United States. The stool bank provides FMT product manufactured from pre-screened donors to healthcare providers and researchers.
FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products from Market
The U.S. Food and Drug Administration issued 22 warning letters to online and brick-and-mortar e-cigarette product retailers and manufacturers across the country who sell flavored, cartridge-based electronic nicotine delivery system (ENDS) products advising them that selling these products, which lack marketing authorization, is illegal. The warning letters were sent to some establishments with well-known names such as 7-Eleven and Shell and are the first of what will be a series of ongoing actions consistent with the FDA’s recently issued policy of enforcement priorities for e-cigarettes and other deemed products on the market.
FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity
Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.
FDA provided updates on efforts in this area, including several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.
New ‘Feed Your Mind’ Initiative Launches to Increase Consumer Understanding of Genetically Engineered Foods
The U.S. Food and Drug Administration, in collaboration with the U.S. Environmental Protection Agency and the U.S. Department of Agriculture, today launched a new initiative to help consumers better understand foods created through genetic engineering, commonly called GMOs or genetically modified organisms.
The initiative, “Feed Your Mind,” aims to answer the most common questions that consumers have about GMOs, including what GMOs are, how and why they are made, how they are regulated and to address health and safety questions that consumers may have about these products.
The FDA, like other government agencies, is taking the necessary steps to ensure the agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Where possible, the agency will leverage technology to host meetings allowing for remote participation.
Visit FDA Meetings, Conferences and Workshops to find out about available meetings.