Resource: FDA Announcement of Coronavirus Aid and Consumer Protections
Source: U.S. Food and Drug Administration
Synopsis: The FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) intended to increase the FDA’s ability to identify, prevent, and mitigate possible drug shortages by enhancing the FDA’s visibility into drug supply chains.
The FDA released a new episode of its podcast, FDA Insight, discussing 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 January 4, 2021, 235 molecular tests, 64 antibody tests, and 11 antigen tests are available. 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.
Comment: It is very important to monitor drug and vaccine availability and the supply chains to ensure equal distribution. The over-the-counter at home antigen test by Ellume was touted as “a major milestone in diagnostic testing for COVID-19.” This is a fully at-home rapid lateral flow antigen test which does not require a prescription. It requires an anterior nasal swab and results are available in 20 minutes by using a smartphone. This will be a game changer for potential testing of pre-operative patients. It is accurate identifying 96 percent of positive samples and 100 percent of negative samples in symptomatic patients. And it identifies 91 percent of positive samples and 96 percent of negative samples in asymptomatic patients.
