THIS IS DUMBASS DOOFUS! I have seen more than one on-camera interviews with Clinical Coronavirus Test Produces that it is the FDA that has told them – in no uncertain terms – that they cannot distribute a single virus test without FDA written, tacit approval. So there are companies with tests available but the TRUMP/FDA has ordered them to cease and desist from ALL RELEASE for sale or distribution of their tests. The Pharmaceutical Laboratories have said over and over they have COMPLETE tests ready to go, they have ALL necessary component reagents to include in the test but they cannot make a move without retribution from FDA!!! THERE IS NO SHORTAGE OF REAGENTS or CHEMICAL COMPONENTS in their test kits!!!
The FDA’s strict guidance on test confirmations is one of several obstacles that has slowed the federal government’s response to COVID-19. The FDA could change its rules to speed things up, but hasn’t.
A federal directive that’s supposed to speed up the response to a pandemic is actually slowing down the government’s rollout of coronavirus tests.
The directive, issued by the U.S. Food and Drug Administration, requires that the Centers for Disease Control and Prevention, a sister agency, retest every positive coronavirus test run by a public health lab to confirm its accuracy. The result, experts say, is wasting limited resources at a time when thousands of Americans are waiting in line to get tested for COVID-19.
The duplicative effort is the latest obstacle that is slowing the federal response to COVID-19, which has infected more than 1,300 people and resulted in 38 deaths in the United States. Progress was already delayed because the CDC decided to make its own test rather than adopting the design endorsed by the World Health Organization. The test then didn’t work properly and had to be fixed. The problems were further compounded by delays in certifying tests by private laboratories as well as a shortage of supplies and raw materials used for testing.
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On Feb. 4, the FDA, which regulates devices as well as drugs, released a document called an Emergency Use Authorization to govern the use of the test. The goal of the emergency authorization is to short-circuit the typically onerous regulatory review that the agency imposes on new diagnostic devices — a process that can take months to years.
In the face of an imminent outbreak, however, the stringently written EUA appears to have become more of a hindrance than a help. Because of the requirement that the CDC rerun tests conducted by public health labs, as of two weeks ago the CDC’s website was lagging in its tally because it was only reporting confirmed cases. The CDC is now reporting both presumptive positives, which have been tested only by local labs, as well as cases it has confirmed…