A report from the United States, one of the places less affected – no, do not laugh, this is true, less affected – with this bureaucracy than many others:
I’ve been working on an N95 mask production project with a team for about a week now. We just got off the phone with NIOSH. They told us that approval for a new mask production facility in the US will take at minimum 45 days, but more likely 90. A lot of people are gonna die.
There is a point at which we will rise up and strangle the bureaucracy for doing this sort of things to us. There is also a point at which we should so rise up and strangle. The tragedy of the modern world is that we’re well past the second point and have not yet arrived at the first.
Friend of mine is head of his own medical manufacturing company.
So I asked him suppose there were no (none) fda like regulations in place on manufacture and deployment of medical machinery – how long would it take you to get into production of beds and ventilators.
The response was essentially that’s a dumb question; I wouldn’t make them without proper testing and nobody sane would consent to using them until they were properly tested.
Sigh
It seems your friend didn’t really answer the question. Any reputable business will perform QA. The answer to the question requires analyzing how long it would take to get a properly tested gizmo to a customer without so much bureaucracy looming over you vs how long it takes with all the bureaucracy.
Indeed; he didn’t even **begin** to answer the question.
I was implying that it ain’t only the bureaucracy that blocks forward movement – the manufacturers appear to have been infected too…
Heads of their own medical manufacturing companies are not infected, they live under the constant terror of being shut down by a politically appointed bureaucrat for paperwork violations. They are unwilling participants in the cult of ceasing to work for good outcomes, in favor of cowering before the possibility of bad outcomes.
I think it’s pretty well established that government deems it better that many people be injured through delayed action or even inaction rather than see some people hurt but many helped by potentially imperfect action.
The problem is not regulatory, so much as legal – though the two are closely connected. You should have asked your friend a slightly different question. “How long would it take you to get into Medical Services production if there were NO BLAME attached to anything you did wrong?.” That’s a simple sum – how rapidly can he start making a profit? You would get the minimum time he could design, source, make and test sufficiently to keep his company’s reputation for adequate quality. Which is the figure we want. I suggest that legal issues are the main factor limiting… Read more »
The FDA on COVID-19 is doing exactly what Dubya Bush’s beloved FEMA did after Hurricane Katrina: blocking good work from being done on the basis that it lacked the necessary approvals. Bush was vilified for defending his Director in the face of logistical screw-ups, but put anyone else on top of this agency and he will do that job and prevent private-sector innovators from doing good work.
I fear we’re all saying the same thing…
“America is at that awkward stage; it’s too late to work within the system, but too early to shoot the bastards.”
― Claire Wolfe
Government bureaucracies are not designed, built or staffed for anything but the most menial, repetitive, ass-covering activities.
Not sure thats fair. Current western governments and societies have succumbed to the strange belief that perfect information and processes are available. They just need to be found. Their is no room for doubt, uncertainty and the occasional poor decision in this mind set. See “Voltaires Bastards” or “The Dictatorship of Reason in the West. John Ralston Saul. Bureaucrats are rewardeds, or at least, not kicked, for nothing happening. It is unreasonable for a culture of fear to have a bureaucracy with courage.