Current FDA COVID-19 news
While the US and other countries continue to struggle with COVID-19 containment, the US Food and Drug Administration (FDA) continues to offer informational resources, advice and actions in the hopes of helping testing developers, pharma companies and consumers deal with the pandemic.
Treatment resource updated
The FDA updated its Coronavirus Treatment Acceleration Program (CTAP) webpage with the latest metrics and updated FAQs. The program is designed to use various avenues to help accelerate development of treatments and tests, while determining if such tests are helpful or harmful.
As of July 31, the agency reports, more than 570 drug development programs are in the planning stages. Additionally, more than 270 trials have been reviewed by the FDA.
Test EUAs granted
The FDA issued an emergency use authorization to George Washington University Public Health Laboratory for its GWU SARS-CoV-2 RT-PCR Test. This molecular test is intended for use by health care providers for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (e.g., nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabs); administration of this test is limited to the George Washington University Public Health Laboratory.
Other tests receiving EUAs:
- Solaris Diagnostics, for its molecular Solaris Multiplex SARS-CoV-2 Assay
- Alpha Genomix Laboratories, for its molecular Alpha Genomix TaqPath SARS-CoV-2 Combo Assay.
- LumiraDx UK Ltd., for its LumiraDx SARS-CoV-2 RNA STAR
- Biomeme Inc., for its Biomeme SARS-CoV-2 Real-Time RT-PCR Test.
To date, the FDA has currently authorized 212 tests under EUAs; these include 173 molecular tests, 37 antibody tests, and 2 antigen tests.
Test EUA revoked
The FDA revoked the EUA for Autobio Diagnostics Co.’s, Anti-SARS-CoV-2 Rapid Test, a SARS-CoV-2 antibody test. The revocation cited performance concerns with the accuracy of the test.
Fraudulent treatments and cures
The FDA, Federal Trade Commission and other agencies have taken actions against companies selling products claiming to prevent, treat or cure COVID-19. To date, the agency has issued no such authorization or approval of such consumer products.
A US District Court in Florida granted motions for default judgment and entered permanent injunctions against defendants Genesis II Church of Health and Healing, Mark Grenon, Joseph Grenon, Jonathan Grenon, and Jordan Grenon for distributing Miracle Mineral Solution, an industrial bleach they claimed could cure COVID-19 and other diseases. The action bars the defendants from selling or distributing the product, and advises consumers to immediately dispose of remaining product.
Other companies cited for false COVID-19 treatments:
- Canadian Chaga, a company selling 124 Chaga Capsules, Chaga Tea, and Canadian Chaga Tincture
- H-Lab Life, which sold Multi-Use Spray products
- Soluciones Cosmeticas, SA de CV, for Bersih hand sanitizers that tested positive for methanol contamination
- Oxford Medical Instruments USA, selling salt inhaler products such as OMI Salt Therapy Pipes
