The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- On Tuesday, the FDA stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.
- On Tuesday, the FDA posted information regarding shortages of hydroxychloroquine and chloroquine to its drug shortages webpage due to a significant surge in demand. The agency is working with manufacturers to assess their supplies and is actively evaluating market demand for patients dependent on hydroxychloroquine and chloroquine for treatment of malaria, lupus and rheumatoid arthritis. All manufacturers are ramping up production, and the agency’s webpage displays current availability. The FDA is working with manufacturers to ensure this can happen expeditiously and safely. The U.S. Department of Health and Human Services (HHS) has also accepted 30 million doses of hydroxychloroquine sulfate to the national stockpile and one million doses of chloroquine phosphate for possible use in treating patients hospitalized with COVID-19 or for use in clinical trials. Use of the donated medications is expected to help ease supply pressures for the drugs. This is a fluctuating and dynamic situation and the FDA is actively engaged. The agency is updating its shortages lists regularly and continuing to communicate in real-time so that patients and healthcare providers have the most current information on product shortages in the U.S.
- On Tuesday, the FDA and FTC issued warning letters to three companies for selling fraudulent products with claims to prevent, treat, mitigate, diagnose or cure COVID-19. One of the companies warned, Halosense Inc., sells salt therapy products with misleading claims that the products are safe and/or effective for the treatment or prevention of COVID-19. Another company warned, Bioactive C60/FullerLifeC60 LLC, sells an unapproved and unauthorized product, “FullerLifeC60,” with misleading claims that it can build up immunity to help treat or prevent COVID-19 in people. The third company warned, JRB Enterprise Group Inc. DBA Anti Aging Bed, offers colloidal silver products for sale in the U.S. with misleading claims the products are safe and/or effective for the treatment or prevention of COVID-19. With these warning letters, the FDA is exercising its authority to protect consumers from companies selling unapproved products and making false or misleading claims during the COVID-19 pandemic.
- 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. On March 30, FDA issued two additional emergency use authorizations for COVID-19 diagnostics, for a total of 22 authorized 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.