"FDA removes threats of fines & imprisonment for one company's point-of-care COVID-19 diagnostic"
When they "authorize" something, all they've really done is removed the prior threat of fines & imprisonment. This threat exists even if the thing they're holding up had little to no risk of harm or confusing anyone. (People, especially those in research labs and the medical profession, are not idiots! Even all sorts of long-approved diagnostic tests have significant errors associated that doctors & patients need to discuss & account for!
This administrative-law threat exists even if traditional product liability – as applies for all sorts of other product/service/info-product category – would be more than sufficient to ensure quality, & punish recklessness.
The FDA's delays have held back US testing capacity for months. The current economic disaster, & many deaths, are a direct outgrowth of both the legislation which gives them this veto-power, and their incompetent exercise of the various discretionary powers they have. They could have offered the same arbitrary waiver that they finally did, on February 29, back in last December!
Even now, urgently needed medical supplies are held up, waiting for FDA inspection/certification backlogs to clear:
A news story: https://www.washingtonexaminer.com/opinion/fda-inspections-c...
Testimony from a Google employee & philanthropic investor: https://twitter.com/mekkaokereke/status/1241151194812186624
The FDA shouldn't get to tout themselves as doing a good thing with this "authorization" – when the risk of harm of such vitally-necessary new testing options is so small that a delay of days, much less months, is unwarranted. Let scientists, doctors, & patients experiment!
Yet they go to the local restaurant who's preparing dishes with no special oversight ex ante, just good logic and the fear of being closed if there's an hygiene investigation ex post.
For some reason, reviews can filter out bad restaurants but not drugs? Even if food can also kill? Evidence of the opposite, from darknet markets where people review drugs and sellers, is routinely ignored.
But when the CDC delivers a non working test, people want more money for the CDC- so that next time, they don't deliver one non working test, but maybe 2 or 3 instead?
My personal conclusion is that the "modern hacker" trust centralization and likes social control - whether it comes from government organizations, or private companies like google or facebook. Based on comments, working there would be a dream from most people here - and not just for the money. People seem to find some kind of prestige in that, for... reasons?
There's a generational disconnect I think. I stopped trying to understand. When I see a movement pushing away Eric Raymond and Richard Stallman, I think it's time to stop associating with this movement, let these people make their own mistakes and hopefully learn from their failures.
Yes, because there are health and safety regulations in place!
Exactly my point: ex post.
The restaurants do not have to declare the recipes they will use or the list of ingredients. They are free to buy from any supplier.
Yet for some mysterious reasons, healthcare needs ex-ante regulations. Read https://thedispatch.com/p/timeline-the-regulationsand-regula... ; do you honestly believe the regulations/FDA/CDC are not at fault here?
They do not have a choice in which medical devices their ER doctor uses.