- 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:
- Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.
The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:
- Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA.
- Include a provision requiring manufacturers of drugs described in section 506C(a) of the FD&C Act or of any active pharmaceutical ingredient (API) or any associated medical device used for preparation or administration included in the drug to develop, maintain, and implement, as appropriate, a redundancy risk management plan that identifies and evaluates risks to the supply of the drug, as applicable, for each establishment in which the drug or API of the drug is manufactured.
- Require drug manufacturers registered under section 510 of the FD&C Act to annually report on the amount of each drug that they "manufactured, prepared, propagated, compounded, or processed” for commercial distribution. The FDA is still determining the best way to receive these data and will notify drug manufacturers when an electronic data submission system is in place.
- The FDA released a new episode of its podcast, FDA Insight. In this episode, Gail Bormel from the Office of Compliance in the FDA’s Center for Drug Evaluation and Research joins Deputy Commissioner for Medical and Scientific Affairs Anand Shah, M.D. for a discussion on drug compounding and its contribution to fighting COVID-19.
- As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to Coco's Holistic Specialties & Apothecary for selling unapproved drug products with fraudulent COVID-19 claims. The company sells tea products, including “4-Thieves Florida Tea Concentrate” and “4-Thieves Florida Tea Powder”, and misleadingly represents that the products can mitigate, prevent, treat, diagnose or cure COVID-19 in people. The FDA requested that Coco's Holistic Specialties & Apothecary immediately address its violations from selling these unapproved products for treatment or prevention of COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
- Testing updates:
- As of today, 310 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 235 molecular tests and sample collection devices, 64 antibody tests, and 11 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.
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.
- Courtney Rhodes