- For Immediate Release:
The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA is working closely with manufacturers to make sure that they continue to notify the agency of any permanent discontinuance or interruption of drug and biological product manufacturing in a timely manner. Today, the agency published guidance for immediate implementation about the importance of these notifications, the timelines for drug and biologic manufacturers to follow when notifying the FDA, and the details for manufacturers to provide about the discontinuance or interruption in manufacturing. Along with the requirements in the statute and implementing regulations, the guidance requests that applicants and manufacturers provide additional details and follow additional procedures to make sure the FDA has the specific information it needs to help prevent or mitigate shortages.
- The FDA issued a Consumer Update, Food Safety and Availability During the Coronavirus Pandemic, to describe the many ways the agency is working to help ensure the foods you, your family, and your pets eat are safe and available.
- The FDA issued a letter to stakeholders about the imminent threat to the health of consumers who may take chloroquine phosphate products used to treat disease in aquarium fish, thinking the products are interchangeable with FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured, and adequately labeled for use in fish--let alone humans.
- Diagnostics update to date: During the COVID-19 pandemic, the FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 19 emergency use authorizations have been issued for diagnostic tests. Additionally, the FDA has been notified that more than 110 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- Stephanie Caccomo