[quote=FlyerInHi]So the South Koreans are able to widely test their population. But we couldn’t use their technology. We had to wait weeks to develop our own, very late in the game, even as we had all the information we needed.[/quote]
The quirk of US law is that you don’t need special clearance to produce a test on a virus until its declared a public-health emergency… then ‘new regulations take effect’… ie; politics gets in the way. The US test was available mid January because of the work the Chinese Doctor did in ‘illegally'(according to CCP’s point of view) publishing the genomic sequencing of the virus.
After the ‘new regulations took effect’;
February 4th, a new regulatory regime took effect. From that point on, any lab that wanted to conduct its own tests for the new coronavirus would first need to secure something called an Emergency Use Authorization from the F.D.A.
Another portion of article;
Jerome said that Greninger had to call and e-mail the F.D.A. multiple times to figure out what they needed to secure an E.U.A. “At one point, he was very frustrated because he’d e-mailed them what we were doing so they could review it,” Jerome said. “But legally you also had to mail a physical copy. Here we are in this SARS-CoV-2 crisis, and you have to send them something through the United States Postal Service. It’s just shocking.” (The F.D.A. has since dropped the requirement to send a CD-ROM or USB drive with a copy of the application.)
That said, there was likely too much of a NIH(Not Invented Here) with regard to using South Korean tests – though it really looks like the FDA and CDC were stumbling over stupid regulations.
another item in the article:
The F.D.A.’s exclusive authorization to the C.D.C. to conduct COVID-19 tests ended up creating “what you’d think of as an agriculture monoculture. If something went wrong, it was going to shut everything down, and that’s what happened.”
