April 9, 2020

COVID-19 Updates from the FDA

With COVID-19 continuing to impact the nation, the FDA has regularly communicated various updates regarding diagnostic testing, clinical trials, and policy regarding supposed treatments. Further information regarding the following updates, as well as new developments as they occur, can be found on the FDA’s Press Announcements page.

FDA Diagnostic Testing Update

In mid-March, the FDA updated regulations to expedite the delivery of diagnostic tests for COVID-19, allowing states to set up a system in which laboratories developing tests can engage directly with the appropriate state authorities, instead of with the FDA. Furthermore, the FDA does not intend to object to commercial manufacturers distributing these newly developed tests.

The FDA is also utilizing their power of Emergency Use Authorization (EUA), a system in which they may allow the use of unapproved medical products or unapproved uses of approved products in a crisis when there are no adequate or approved alternatives. Currently the FDA is working with over 380 developers in the hope of granting EUAs for diagnostic tests to detect COVID-19, with 50 such tests receiving EUAs.

Several COVID-19 tests are being utilized; some take days, hours, or minutes, but they employ different methods. An antibody test has recently been approved. However, the FDA has reiterated again and again that at this time, no at-home diagnostic tests exist for COVID-19. Any product claiming to do so is fraudulent, and the FDA is currently investigating such products. The FDA did grant an EUA for one diagnostic test that permits the testing of samples self-collected by patients at home, but samples must be sent of to a lab for testing.

The Use of Chloroquine and Hydroxychloroquine

Many media outlets have reported on the potential use of chloroquine, an anti-malaria drug, to reduce symptoms of COVID-19. The FDA has not issued an official approval of the use of chloroquine for COVID-19, however they have taken several actions regarding such products.

This includes issuing an emergency use authorization (EUA), a system in which they may allow the use of unapproved medical products or unapproved uses of approved products in a crisis when there are no adequate or approved alternatives. This specific EUA allows for hydroxychloroquine sulfate and chloroquine phosphate products donated to Strategic National Stockpile to be distributed and used for certain hospital patients infected with COVID-19.

Furthermore, the FDA approved an abbreviated new drug application (ANDA) for hydroxychloroquine sulfate tablets. While the ANDA does not cover COVID-19 in its indications, it does allow for more generic manufacturing.

And finally, the FDA is working with manufacturers to expedite the production of these products. However, the FDA warned that chloroquine phosphate products created to treat diseases in aquarium fish are not exchangeable with other formulations of chloroquine. Furthermore, the FDA is reporting serious heart rhythm problems in COVID-19 patients treated with hydroxychloroquine or chloroquine. These drugs should only be used in limited circumstances in hospitalized patients as outlined by the FDA.

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