Here's what happened yesterday while you were preoccupied with voting, wall-to-wall media coverage of Super Tuesday and Fed Chair Jerome Powell remarks.
President Trump held a roundtable briefing on coronavirus yesterday at the Vaccine research Center at the National Institutes of health in Bethesda, Maryland.
During that briefing HHS Secretary Azar was asked the following question:
Mr. Secretary, can you talk about your meeting with lawmakers today and what specifically they’re asking the federal government? What’s their biggest concern?
Here's his response:
As you know, our excellent teams down at the CDC developed the test really in record time, within t CD- -- at the FDA, under an emergency use authorization in record time.weeks of getting the genetic sequence back in January. And we approved the diagnostic at CD- -- at the FDA, under an emergency use authorization in record time.
We’ve been able to be testing at CDC throughout, without any backlog in testing. Our throughput has been great there. We've had 12 labs qualify to be able to do the testing. We did suffer a manufacturing issue on that test as it went out to the rest of the public health labs.
We've gotten that issue solved in the last week, so that’s up and running in the public health labs. We also have gotten this test produced by this contractor to get it out. So we will, this week, have up to 75,000 tests shipping out there to public health labs, as well as available to hospitals who order it.
And then something really important happened on Saturday morning.
So one of the biggest issues around testing that people don’t understand is, during the Obama administration, the FDA, for the first time, asserted control and regulatory jurisdiction over what are called "lab developed tests."
Before that, if a hospital or a lab, like a Quest Diagnostics, a Lab Corps, or an academic medical center would develop a test on their own with reagents and tests, they could just do that if they were a certified clinical lab, called a CLIA lab.
But under the Obama administration, the FDA asserted jurisdiction and said, "You have to come to us first and get approval of that test before you can do it." On Saturday morning, Commissioner Hahn issued guidance saying, under an emergency use authorization, we are permitting these labs -- these public health labs, these hospital labs, commercial labs -- to go ahead, get the test going, do your own test, make it available, and come to us for approval after the fact under emergency use authorization.
That will make, as Commissioner Hahn has said, millions of tests per week available quite rapidly.I'm beginning to wonder if it's even necessary to hold a Congressional vote on a coronavirus supplemental spending bill.
