The U.S. Food and Drug Administration (FDA) appears to have avoided the charges by saying it has encountered a “bottleneck” in the testing of the new corona virus, and dismissed criticism that the COVID-19 test has been delayed because of its negligence, according to slashGear. In recent weeks, detection figures in the United States have become a controversial topic in the new corona virus pandemic, suggesting that uncertainty about how many Americans may infect them has left health care providers in trouble and unprepared.
Of course, the testing didn’t go as smoothly as many had hoped. The U.S. Centers for Disease Control and Prevention (CDC) has developed a test that can be deployed in laboratories across the United States, but it has found problems that make it unreliable. Alternative products must therefore be developed, and it is not clear what causes this.
Since then, getting COVID-19 testing has been a controversial topic. Even without showing any widely expected symptoms, several prominent politicians, athletes and businessmen have been tested for the new coronavirus. Meanwhile, the wide-ranging public tests promised by U.S. President Donald Trump have not emerged.
One suggested explanation was that the potential COVID-19 test had been blocked by the FDA, a claim the agency said Monday was completely false. “FDA regulations do not prevent the spread of testing during pandemics,” FDA Director Stephen M. Hahn, M.D., said in a statement Monday. In this public health emergency, each FDA action to address the COVID-19 pandemic balances the urgent need to provide diagnostic testing with a certain level of oversight to ensure accurate testing is deployed. “
The FDA does not develop its own testing methods, nor does it define which tests should be used by healthcare providers. Instead, it focuses on the accuracy and reliability of the results. Dr Hahn points out that this is the case, “even if some people want us to test them in the market without evidence that they are feasible.” “
Hahn said the agency has worked with more than 230 developers since the beginning of the year, and they have submitted or are expected to submit requests to the FDA for urgent authorization for its tests. So far, 20 such authorizations have been granted. More than 110 labs have notified the FDA that they have started using their own tests.
Currently, there is an Emergency Use Authorization (EUA) covering coronavirus testing. This effectively relaxes the standards for new testing and speeds up the FDA review process. “In many cases, the FDA can complete this review in as little as a day, and this review has been repeated,” Dr. Hahn said. “But even with THE EUA, it needs to develop and submit actual tests.” None of this has happened: for example, only six labs took advantage of simplified processes in the first week. In many cases, Dr. Hahn explains, the lab either does not have tests or virus samples to check the accuracy of the tests.
As part of the $2 trillion stimulus bill signed on Friday, the FDA received $80 million in additional funding for its COVID-19 response.