Posted on 04/16/2020 10:23:23 AM PDT by rintintin
February was a frustrating month for my laboratory. We wanted to make tests to detect the virus that causes Covid-19. My virology colleagues had great ideas and solid testing platforms. The Food and Drug Administration told us to stop.
Why? Because of a quirk in FDA regulations. Diagnostic tests are currently regulated in one of two ways, and there’s no clear rule to determine which one applies to coronavirus tests. This uncertainty is a big part of why test shortages have caused a national crisis.
The VALID Act, introduced in Congress in early March, aims to address the confusion about who regulates diagnostic testing, but it would make the situation worse. If the VALID Act passes, we would see shortages in diagnostic tests for even more diseases than Covid-19, including cancers.
Under one system of regulation, laboratory directors are licensed by their states to develop tests through a set of rules called the Clinical Laboratory Improvement Amendments (CLIA). When a CLIA-licensed lab creates a test and documents that it works, doctors can order that test.
Diagnostic testing, and interpreting those tests, is considered the practice of medicine. The FDA is not allowed to regulate the practice of medicine. Yet it is responsible for regulating medical devices. Diagnostic tests use machines, sample tubes, and other tools that are clearly medical devices.
Here’s where the second system comes in: The FDA approves devices — not the lab that produces it — on a case-by-case basis. So which diagnostic tests are devices regulated by the FDA and which are laboratory-developed tests regulated through CLIA?
The FDA gets to choose.
In early February, the FDA issued an Emergency Use Authorization and by doing so declared that coronavirus tests are medical devices. It assumed authority and chose to work exclusively with (CDC) ...
(Excerpt) Read more at statnews.com ...
It was obvious from the beginning, that the Left was screaming about testing that they want every person to be tested for something they have planned they already have the Obama database.
Reinforces my point that testing all 350 million of us is impossible.
Red tape just makes me twice as right.
Odd that our very own bureaucracy is more likely to bring us down to our knees long before foreign invaders swing their sword over our heads and homeland... but not unexpected.
Yes. There is plenty of private sector capacity to run viral tests and antibody tests. What do you think all these companies do for a living?
Almost all the media and almost every Dem politician and partisan pushes the “Blame Trump” narrative for purely political reasons. Not only do they hate Trump they want to protect their bureaucratic feifdoms. They have each others’ backs. They want to assign blame to one man, and deflect blame from where it belongs.
But the failures have been the result of poor planning, allowing inventories to be depleted, over-regulation, CYA attitudes, statistical purists, bureaucratic red tape and more.
After the 2009 pandemic the FDA/CDC/NIH/HHS depleted the inventory of supplies and never replaced them. Then they stripped the state and private hospitals from being able to run tests, and wrote rules requiring they use the same old machines that are in the FDA offices - which you probably cannot even find if you wanted to buy one - and specific reagents. So even though there is plenty of capacity to test in the private sector the government literally ordered them not to!
Trump had to knock their heads to loosen the rules.
Trump had to force the FDA.
Trump had to kick butt at the CDC, and the CDC took weeks to approve a test based on their own mishaps.
Trump stopped travel from Asia.
Trump pushed the drug companies to work on anti-viral drugs.
Trump forced the CDC/FDA/NIH to allow private labs to test.
Trump forced the FDA to loosen the rules on HQC.
Notice the pattern here? Trump has done everything he could, and has been met with nothing but resistance from the bureaucrats; either from inertia or outright mutiny. When Trump ordered the Alphabet Swamp to act, they needed to act across the board and should not have required him to go back again and again to force them to take each and every action.
Reinforces my point that testing all 350 million of us is impossible.”
Only because of our federal bureaucracies. They’re getting in the way.
But we were able to vaccinate the entire population for small pox and polio, so testing the population for COVID is not impossible, the swamp is making it artificially difficult. Question is: Are they doing so to hurt Trump? Just like their brother bureaucrats in the FBI and CIA did their own part to hurt Trump?
“It was obvious from the beginning, that the Left was screaming about testing that they want every person to be tested for something they have planned they already have the Obama database.”
Widespread testing makes sense. That’s why Taiwan is doing it, to keep their economy open.
Our bureaucracies are thwarting it. Media won’t call them out, because media loves bureaucracies.
Trump should be calling out the FDA and CDC. Unfortunately, he has Dr Birx and Fauci standing by his side.
I’m not sure whether FDA and CDC are slow-walking testing because they’re power-jeaolous bureaucrats, or because they want to hurt Trump, like their fellow swampsters in FBI and CIA.
Deep state at it again.
Quarantines are supposed to keep the small amount of sick people from going out!
They are not for keeping the vast majority of healthy people locked inside.
If a person is healthy, he/she doesn’t need a test to prove that they are healthy.
It has been obvious that FDA, CDC and those who make money off of CV19 have cried for testing in the open. Then, behind closed doors, they made sure that simple/valid/low cost testing on a large scale was not available.
Reinforces my point that testing all 350 million of us is impossible.
Red tape just makes me twice as right.
Really good information on how screwed up the FDA is on disease testing. Treating every unique test as a separate medical device is assinine. Device approval hoops are not fun to jump through. And very costly.
Seems we need to tell our reps NO to the VALID act, being pushed through quietly by big pharma!!!
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