(1) The FDA is currently allowing some testing to continue despite the fact that they know the results are not fully accurate.
https://www.fda.gov/news-events/press-announcements/coronavi...
(2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first.
I think the FDA has done an overall shit job at managing this crisis but everyone needs to keep the bigger picture in mind. It might seem like a really good idea to bypass a whole slew regulations right now but it has to be done carefully because those regulations have been written in blood of countless individuals. With over four million confirmed cases, any mitigation or response will be deployed at a massive scale. Any mistake, any oversight will be magnified across tens perhaps even hundreds of millions of people.
Over four million are infected now. A lot more could suffer at the hands of eager arrogance.
You think rocket science is harder than regulatory compliance? At least the rules of physics don't change all the time.
The majority of US health regulations have been written by medical corporations in order to keep competition out. While no regulation is certainly bad, current regulation for a large part simply drives up prices and lowers availability. Far more people in the US are killed by red tape than medical quacks.
>2) It's unlikely the company was willingly not complying with the FDA and common sense here would dictate a formal warning first
Halting until authorization is a formal warning, you can't just allow human experimentation without knowing they meet the requirements.
100,000 Americans have died from this disease in the past 8 weeks. We can't afford to be cautious. Imperfect tests are better than nothing, especially if there are no bureaucratic hurdles to prevent the deployment of refined versions (such as saliva samples instead of nose swabs).
If not for the FDA, we would have an order of magnitude more testing. We'd have human challenge trials. We might even have variolation experiments. All of these could reduce the death rate by an order of magnitude. At this point it is no exaggeration to say that the FDA is responsible for mass death.
1. https://www.nytimes.com/2020/03/10/us/coronavirus-testing-de...
I had hoped that people would see what has happened with the coronavirus testing and realize that these issues are systemic and have far reaching consequences beyond the current crisis.