Why can’t you find formula for your baby? Lockdowns and the FDA
A couple of weeks ago, I saw a post in a Facebook group for residents of my neighborhood where a desperate mother was asking if anyone knew a store that…
This last weekend, an ad popped up on my Facebook timeline from Allina Health. They were asking for the public to donate masks to them.
This brought home a very real problem. In early March, the Department of Health and Human Services said that America’s stockpile of N95 masks – so-called because they filter out 95% of airborne particles – was only about 1% of the three billion masks we would need during a pandemic. And so, in the richest country on earth, we have the Centers for Disease Control and Prevention (CDC) advising healthcare workers without masks to wear scarves and bandanas instead.
We need lots more masks and we need them quickly. There are suppliers willing and ready to step up. One Tweeted a week ago today:
THREAD: I mostly talk about movies on here, but here goes. We are currently pivoting our factory to solely make surgical masks and other medical garments in short supply. We can make 2 million masks a day, and are looking to help in any way possible during this time. #COVID19 pic.twitter.com/dOX7N3e1GJ
— Jeffrey Zhang (@strangeharbors) March 20, 2020
But he followed up by saying that “Bureaucracy and red tape are making this hard”. In the midst of a public health crisis, what could conceivably be the problem? Christian Britschgi at Reason gives a good summary:
The production of N95 masks is regulated by the CDC’s National Institute for Occupational Safety and Health (NIOSH). Prospective makers of N95 masks must submit detailed written applications to NOISH, and send finished products to its Personal Protective Technology Laboratory for testing. NIOSH staff must also personally inspect new manufacturing sites before they’re allowed to start pumping out masks.
[Matt] Chisholm says regulators have told the Open PPE Project [a group of about 15 engineers, technologists, and others who are attempting to set up their own N95 mask production facility] that getting agency approval could take anywhere from 45 to 90 days.
“The problem with that is that you have possibly 45 days to 90 days of product that could be used to save lives that is now sidelined,” he says. Complicating things further, he continues, is that NOISH inspectors are under travel restrictions (as are most federal workers), potentially delaying approval even longer.
Don’t we need this regulatory apparatus to assess the effectiveness of these masks, to ensure that they offer the protection they claim?
This is a false choice. The choice is not between masks produced by enterprises like the Open PPE Project and code-compliant masks, but between masks produced by enterprises like the Open PPE Project and no masks at all. What is that like?
With shortages only likely to grow worse as the spread of COVID-19 accelerates, that means many healthcare workers are having to go without.
“About a week ago, we were told that we were going to get PPE-appropriate N95 masks, surgical masks, and gowns and gloves would be ordered,” says one hospice worker who spoke with Reason last Friday. “But then I guess like everywhere supplies were not readily available.”
This hospice worker, who asked not to be named because she doesn’t have permission from her employer to speak to the press, says she was given a PPE bag containing a single N95 mask, plus gloves, a rubber gown, and foot coverings, all of which she was told to reuse.
“Pretty quickly you realize that’s not sufficient, especially considering the population we serve,” she says, noting that the elderly are particularly vulnerable to the COVID-19 virus. “I used to work in a hospital. I’m thinking of all this as disposable. You see one case and then you throw it all away. That realization hit pretty quickly.”
Her story is being repeated across the country as doctors and nurses report being forced to reuse masks or go without them completely.
On Wednesday, faced with this regulatory thicket, Mr. Zhang tweeted:
URGENT: We have come to the conclusion that we are at an impasse with @US_FDA. We have millions of lab-tested masks ready for #COVID19, but we've received no guidance. Now reaching out to Twitter brain trust. Anyone with information or a contact at the FDA, please DM me.
— Jeffrey Zhang (@strangeharbors) March 25, 2020
3M might well be planning to produce more than a billion masks by the end of the year, but that is only one-third of the masks we need and the crisis is here with us now, a glut of masks nine months from now will be of little help.
Don’t we need to worry about opportunists making personal protective equipment (PPE) which is ineffective? Won’t we end up with ‘snake oil’?
No. This reminds me of the old ‘joke’:
Ayn Rand, Rand Paul, and Paul Ryan walk into a bar. The bartender serves them tainted alcohol because there are no regulations. They die.
Well, ok, but who goes to the bar the day after this? Nobody who isn’t suicidal. What happens to the bartender? He loses his job or goes out of business. The same applies to anyone selling PPE. And if they knowingly sold PPE which didn’t work as promised, they would be legally liable.
On Tuesday, I wrote about how federal regulations—and regulators—held up coronavirus testing. And again, in the case of N95 masks, regulations which are supposed to safeguard public health turn out to be obstacles in a public health crisis.
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