Fox News senior political analyst Brit Hume shared an eye-opening thread on the government bureaucracy that is impeding a faster delivery of masks and respirators to combat the coronavirus outbreak.
As President Donald Trump continues to get blamed by critics for everything from the lack of availability of testing kits to the dearth of surgical masks and respirators, Hume tweeted a link Thursday to a thread on “the regulatory state” by author and historian Paul Matzko.
“The Covid 19 emergency meets the regulatory state. The regulatory state is winning,” Hume wrote.
The Covid 19 emergency meets the regulatory state. The regulatory state is winning. Thread. https://t.co/h0KmFeE6HS
— Brit Hume (@brithume) March 26, 2020
“Wondered why it’s been so hard to ramp up production of surgical masks and respirators? Why haven’t private companies flooded into the market to meet peak demand?” Matzko wrote in the first of a series of tweets Wednesday addressing the shortage of personal protective equipment in the wake of the global pandemic.
“Because they are regulated medical devices & new versions require FDA approval which can take months to obtain,” he continued as he pulled back the curtain on how long-standing regulations are to blame for the problems, not – to the disappointment of the left – Trump himself.
He shared the cumbersome application process needed to be completed before the much-needed masks could even be marketed.
Take a look at this FDA regulation, intended to ease (!) the application process for “premarket notification.” That means you have to do all of this–and get FDA sign off–before your new surgical mask gets anywhere near shelves. 2/ https://t.co/fNzWcXKeFl
— Paul Matzko (@PMatzko) March 25, 2020
“Let’s say that you’re a garment manufacturer in NYC, but, of course, retail sales are down, so you’re looking for another revenue stream. Why not make surgical masks, keeping your doors open, employees employed, and saving lives?” Matzko tweeted. “It’s a win-win-win!”
“But how long do you think it would take you to jump through these hurdles, and do you think someone without an army of regulatory compliance officers would be reasonably able to do so at all?” he asked before revealing how the federal bureaucracy ends up getting in the way.
To start, you must:
– do a compositional side-by-side analysis of your mask vs all other masks currently sold. Hire a few materials scientists, okay.
– measure “tensile strength” & “impact resistance.” Hire the Mythbusters and have them whack it with a hammer.
— Paul Matzko (@PMatzko) March 25, 2020
– perform detailed “risk analysis,” for fluid/bacteria resistance and “flammability.” Hmmm, better open a branch office for all those extra materials scientists and medical researchers. This is multiple major studies (though a Boring Company flamethrower might work in a pinch.)
— Paul Matzko (@PMatzko) March 25, 2020
– but wait, don’t forget that masks touch skin! What if it gives you a rash!!! Okay, fine, we’ll fill out the “standard ISO-10993,” yeah, you know, the one for “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” Sprinkle in a couple more clinicians.
— Paul Matzko (@PMatzko) March 25, 2020
“I could go on and on,” Matzko wrote, and thankfully did not, noting how it would be near impossible for a company to “jump through these hurdles” and meet the critical need facing the nation in the grip of COVID-19 which has infected nearly 70,000 people in the U.S. so far.
I could go on and on. There is no world in which any company not already deeply invested in manufacturing surgical masks could jump through these hurdles in time to mitigate the desperate shortage of PPE for medical professionals on the COVID-19 front lines. None.
— Paul Matzko (@PMatzko) March 25, 2020
With all that is at stake, the FDA “should waive its surgical mask/respirator regulations for the duration,” Matzko tweeted.
And we could have a discussion over whether these steps are necessary in ordinary times. But we aren’t living in ordinary times.
Just as the FDA waived its COVID-19 testing regs (after weeks of delay), it should waive its surgical mask/respirator regulations for the duration.
— Paul Matzko (@PMatzko) March 25, 2020
But since it hasn’t, the supply of officially-approved masks has remained artificially constricted. New entrants are effectively barred from selling unapproved masks.
— Paul Matzko (@PMatzko) March 25, 2020
He noted that the current situation leaves Americans thinking that the shortage of supplies is a “market failure,” and thus, a Trump failure, while “it is anything but.”
But because most people are unaware that masks/respirators are considered medical devices and just how onerous the applicable rules are, it leaves people thinking that the PPE crisis is a market failure, when it is anything but.
— Paul Matzko (@PMatzko) March 25, 2020
Matzko argued that the government agency’s heavy-handed rules are exactly what is behind the current problem.
That leads folks to consider towards heavy-handed measures, like the government seizing the means of mask production. This is problematic for a bunch of reasons (& likely less effective), but it’s also completely unnecessary if the FDA would just DROP THE DAMN RULES.
— Paul Matzko (@PMatzko) March 25, 2020
And Democrats like Senators Brian Schatz of Hawaii and Chris Murphy of Connecticut continue to argue for the federal government to take over the medical supply chain.
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Originally from New York, Powers graduated from New York University and eventually made her way to sunny South Florida where she has been writing for the BizPacReview team since 2015.
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