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Obama’s Ghost Haunts Coronavirus Response

Trump Coronavirus
“The Obama administration made a decision on testing that turned out to be very detrimental to what we’re doing, and we undid that decision a few days ago so that the testing can take place in a much more accurate and rapid fashion,” President Donald Trump said at a meeting with airline executives on March 4 at the White House.

He was soon criticized by the establishment media for “falsely” claiming that he ended Obama-era rules.

“The president was right,” said Roger Klein, a former advisor to the FDA and former director of molecular pathology at Cleveland Clinic., adding that it wasn’t a regulation, but a policy originated under Obama.

“I don’t know who initiated it, but I think it happened at the career level.”

To remove the barriers, the agency issued guidance on Feb. 29 expanding the number of laboratories eligible to provide testing. The agency said it would allow labs to create and use their own in-house tests immediately, without FDA review, as long as they completed an emergency use authorization (EUA) request within 15 days.

Robert Redfield, director of the Centers for Disease Control and Prevention, on March 4 at the White House meeting described the regulatory change made by the Trump administration.

“In the past, we used to be able to have laboratories that could develop what we call ‘laboratory-developed tests’ and then be able to apply them for clinical purposes. And in the previous administration, that became regulated so that now for someone to do that, they had to formally file with the FDA,” Redfield said.

And with recent changes, university labs and other labs in the country “can be fully engaged in developing laboratory diagnostics for the clinical arena,” he said according to reporting by Emel Akan, White House economic policy reporter for The Epoch Times.

At a White House press conference on Tuesday afternoon, Vice President Mike Pence, who heads the country’s coronavirus task force, said that by the end of the week, there will be more than 5 million tests available and that industry is ramping up production of even more, reported Jon Cohen, a staff writer for Science. Pence stressed that the government has also removed criteria that initially restricted testing to people who had traveled to China, come in contact with a confirmed case, or had severe symptoms. “As the president said, anyone who on a doctor's order wants to be tested, can, at a doctor's indication, be tested now,” Pence said.

To speed things up even more, on 9 March CDC revised its COVID-19 guidelines to require testing only one patient sample, rather than two, which will cut the reagent needs in half.

Linoj Samuel, who heads the clinical microbiology division that oversees lab testing for the Henry Ford Health System in Detroit, spoke with Science about the situation he’s facing. Henry Ford has six hospitals and many medical centers that cover most of southeast Michigan. As of CHQ post time, the state has yet to have a confirmed COVID-19 case.

Samuel told Science, initially, “there were very restricted criteria based on travel and other issues to decide who can get tested. So we didn't really test that many patients. But since CDC relaxed their criteria, that has changed, and so in the last day or two, we've been testing more patients. We are in the process of acquiring reagents for our own in-house testing. We've ordered them from the CDC-designated vendor and we should be getting them in the next day or two. But that doesn't mean we can just turn the switch on and start testing. We'll still need to do a fairly extensive validation based on the FDA requirements for emergency use authorization.”

Samuel continued, “It’s clear that they have been shipping out a lot of test kits. We expect to get them tomorrow. I don't think that's really the issue anymore. I think the challenge for us is doing all the other stuff that's required as part of this process. We could have been working on this earlier, if FDA had relaxed the requirements earlier. But in the past, the process was very rigorous, and really too much of an undertaking for your average clinical laboratory. So we've stayed away from that kind of a process. And even now, it's no cakewalk—it's a fairly rigorous process. It's just not simply plug and play. We can’t just turn them on and start testing.”

As of March 7, Food and Drug Administration Commissioner Stephen Hahn said the CDC has sent out enough test kits to test 75,000 people. But those are just the tests sent to public health labs. An additional 1.1 million tests (produced by private industry) have been sent out to non-public commercial and academic labs, according to Hahn. In all, once the Obama-era rules were relaxed, he estimated 850,000 Americans are now able to be tested.

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