Tuesday, August 04, 2020

The FDA, Masks and Type I & Type II Errors

See FDA’s Shifting Standards for Chinese Face Masks Fuel Confusion: Some states stop using KN95s to protect workers; agency cites ‘regulatory flexibility’ by Austen Hufford, Liza Lin and Mark Maremont of The WSJ.

I use the book The Economics of Public Issues in my micro classes. Chapter 1 is called "Death by Bureaucrat." It discusses how the Food and Drug Administration can make either a Type I error or a Type II error.

Type I error: The FDA approves a drug before enough testing is done and when people take it, there are harmful side effects.

Type II error: The FDA tests a drug longer than necessary to stay on the safe side. But people might suffer because the drug is not yet available. 80,000 people died waiting for Septra to be approved.

The FDA would usually rather make a Type II error because the public can blame the FDA if a Type I error occurs. But in this case, they wanted to get masks to people quickly. Not enough testing was done. So it looks like a Type I error.

Excerpts from the article:
"Facing a severe shortage of N95 respirator masks in the early days of the coronavirus pandemic, the FDA made an emergency decision to allow importation of millions of Chinese-made masks, generally called KN95s, that were supposed to provide similar levels of virus protection.

But the FDA itself created confusion about which Chinese brands could be trusted for medical use, in part by giving—then revoking—its stamp of approval to masks that turned out to be subpar."

"The agency also relaxed its rules governing Chinese masks aimed at the general public, allowing hundreds of brands to be sold with little oversight and few quality checks"

"The FDA said its main goal was to help hospitals obtain quality masks and that it has never told the general public to use KN95s. It relaxed restrictions on masks of many kinds in response to public demand for face coverings during the pandemic, the agency said."

"*More than 60% of foreign-made masks, nearly all Chinese made, have failed basic U.S. government quality tests that looked at 220 such brands, according to U.S. regulatory data."

"*More than 3,500 Chinese manufacturers that have registered to sell KN95s in the U.S. were never fully vetted by any U.S. agency; some make virus-protection or filtration efficiency claims the FDA explicitly forbade when it relaxed the rules."

" “The FDA was in a Catch-22 situation,” said Vernessa Pollard, a former FDA enforcement lawyer now at McDermott Will & Emery. It needed to relax regulations to respond to the shortage of protective gear, but bad actors inevitably take advantage of under-regulation, she said."

"Federal officials realized there was a severe shortage of U.S.-certified N95 masks made both domestically and abroad."

"It gave essentially unfettered entry to masks intended for use by the general public, as long as the makers labeled them as face masks and didn’t advertise filtration efficiency or claim that the masks could protect against viruses."
Related posts:

Remdesivir and Type I & Type II errors

Do FAA drone regulations illustrate the tradeoff between Type I & Type II errors

Maker Of Thalidomide Apologizes

The Paycheck Protection Program and and Type I & Type II Errors

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