White Oak, MD….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 recently issued an emergency use authorization (EUA) for a blood purification system to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure. The FDA issued the EUA to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices.
- The FDA recently issued an EUA to decontaminate compatible N95 or N95-equivalent respirators for reuse by health care workers in hospital settings. The FDA issued the EUA to STERIS Corporation for the STERIS V-PRO 1 Plus, maX and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle), which uses vaporized hydrogen peroxide. This EUA will support decontamination of approximately 750,000 N95 respirators per day in the U.S.
- The FDA issued a guidance for immediate implementation for pharmacy compounders that experience shortages of the personal protective equipment (PPE) they typically use to compound human drugs that are intended or expected to be sterile. PPE shortages have the potential to significantly impact the quality, purity and availability of drugs that are compounded for patients, including those in critical need. The guidance discusses how pharmacies may be able to preserve PPE if supplies are limited. Further, as a temporary measure to address the public health emergency posed by COVID-19, the agency is providing limited regulatory flexibility for compounders that cannot obtain sufficient supplies of PPE for sterile compounding, provided they adopt risk mitigation strategies as described in the guidance. FDA adopted this policy to help assure patient access to needed medicines and to reduce the risks of compounding when standard PPE are not available.
- Yesterday, the FDA and Federal Trade Commission issued a warning letter to one company for selling fraudulent COVID-19 products, as part of the agency’s effort to protect consumers. The seller warned, Earthley Wellness DBA Modern Alternative Mama LLC., offers unapproved and misbranded herbal tinctures and herbal remedy products for the prevention or treatment of COVID-19. There are currently no approved preventatives or treatments for COVID-19. Consumers should not purchase or take any product to prevent or treat COVID-19 unless it is prescribed by their health care provider and acquired from a legitimate source.
- FDA Voices: A Perspective on the FDA’s COVID-19 Response by Mitch Zeller, director of the FDA’s Center for Tobacco Products, was issued. It provides a perspective of the FDA’s “all-hands-on-deck” approach to tackling this pandemic. The FDA is integral in the fight against the coronavirus, using science and innovative approaches to take a broad range of actions that advance our nation’s response.
- The FDA issued a Letter to Stakeholders advising people not use ivermectin intended for animals as a treatment for COVID-19 in humans. People should never take animal drugs, as the FDA has only evaluated their safety and effectiveness in the particular animal species for which they are labeled. These animal drugs can cause serious harm in people. People should not take any form of ivermectin unless it has been prescribed to them by a licensed health care provider and is obtained through a legitimate source.
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 300 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
- To date, 33 emergency use authorizations have been issued for diagnostic tests.
- The FDA has been notified that more than 170 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.