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BREAKING: White House takes away FDA authority to regulate COVID tests. It’s August, de-regulating & politically meddling are not what FDA needs right now.
More soon. Follow if interested.
More soon. Follow if interested.
The FDA is always in a position where people are upset that they go too slow: and we don’t have enough. Or too fast: they approve stuff that doesn’t work.
But their EUA (ability to approve things on an emergency basis) has been their path to try to get the best of both worlds.
But their EUA (ability to approve things on an emergency basis) has been their path to try to get the best of both worlds.
Early on, when the country had no tests and labs around the country were offering to make them, a move like this might have prevented the virus from spreading.
We could have contained it with massive mobilization. But we were cautious.
We could have contained it with massive mobilization. But we were cautious.
Now, 6 months later, the White House is tired of complaints that there isn’t enough testing. A good strategy might be to listen to people like @michaelmina_lab and develop multiple types of tests with specific approaches. He is pushing for home based tests specifically.
Imagine:
-tests designed for school entry & colleges. Rapid, low cost, not as sensitive.
-tests designed to find prevelance in a community. Low cost, saliva based, quicker turnaround.
-for symptomatic people. Highly accurate. 1-2 days max turnaround. https://coronavirus.medium.com/why-testing-improvements-are-so-critical-c2713f925861
-tests designed for school entry & colleges. Rapid, low cost, not as sensitive.
-tests designed to find prevelance in a community. Low cost, saliva based, quicker turnaround.
-for symptomatic people. Highly accurate. 1-2 days max turnaround. https://coronavirus.medium.com/why-testing-improvements-are-so-critical-c2713f925861
Instead the White House has one switch: Laissez-faire inaction & laissez-faire late action.
So now it’s a free for all. Labs will be able to make and sell tests & you won’t be able to see the data on how well they work. False positive, false negative.
So now it’s a free for all. Labs will be able to make and sell tests & you won’t be able to see the data on how well they work. False positive, false negative.
False positives? False negatives? We won’t know.
But it will be profit time for people with approved labs (you need a designation to qualify). Will it be enough to make a dent in the massive demand & turnaround time?
But it will be profit time for people with approved labs (you need a designation to qualify). Will it be enough to make a dent in the massive demand & turnaround time?
I talked to someone yesterday who had developed a test and had data on 1 patient. They were working on getting data on 30 people. Now they don’t need to any more.
Perhaps the biggest harm is to our ability to trust the FDA can be kept free from political interference as a vaccine comes out.
