FDA Red Tape Has Been Lethal During the Pandemic

City Journal’s John Tierney, who is also a New York Times science columnist, brought us the revolutionary news that those banned plastic grocery bags may be more sanitary and environmentally safe than those virtue-signaling reusable bags.   

Now, the iconoclastic Tierney is back this morning bringing us a chilling account of how the Food and Drug Administration’s bureaucratic rules are causing people to die during the coronavirus pandemic (“The FDA Graveyard”).

FDA’s regulations have delayed the delivery of tests and supplies. And, while the pandemic reveals the agency’s obstructionism, it is nothing new. Countless Americans have died because the FDA has delayed treatments for cancer, heart disease and other fatal conditions.

Tierney stresses that this is not because of one person or some mistake—it is because of a web of esoteric regulations that hamper the FDA’s ability to respond quickly. FDA officials claim that because of the virus, they are now moving as fast as they can, “and, unfortunately, that’s true,” writes Tierney.

You may already be familiar with the fist test kid fiasco. A German test was available in mid-January, and other countries used it. Doctors in the U.S. were unable to use it because it had not been sufficiently tested by the FDA, which authorized the Centers for Disease Control to make another test. These tests could not be made quickly enough and ultimately were faulty.

Seattle researchers were prevented from performing testing on their own because they had not used proper consent forms for volunteers and failed to follow other byzantine regulations.

Under pressure from the White House, the FDA gave some private labs permission to provide tests without FDA approval—but the FDA rescinded this permission when it learned that some of the tests were at-home tests. The FDA ordered that production of the tests must be halted and all samples collected destroyed. Can’t be too safe, right, even if it kills somebody?

Tierney writes:

Meantime, other FDA regulations exacerbated the shortages of masks and other personal protective equipment. It took an act of Congress, effective March 20, to bypass an FDA policy that restricted companies from providing hospitals with construction-worker masks that were virtually identical to the ones approved for medical use. It took a personal appeal to the White House in late March from Ohio’s governor— and the state’s threat to sue the FDA—to overturn a policy that had needlessly hampered hospitals from using a system to sterilize masks.

Companies hoping to begin manufacturing masks found that it would take from 45 to 90 days to get regulatory approval to start production. As wholesalers scrambled to import FDA-approved masks, they complained that deliveries were being delayed for weeks by the FDA’s byzantine licensing requirements and by the unnecessarily elaborate quality-control tests of shipments.

Another obstacle was the FDA’s opposition to importing types of masks not approved by the agency but widely used overseas and more readily available on the international market. Not until March 24 did the agency relent, and then only partially, because it still excluded the most widely available alternative, a mask used in Chinese hospitals closely resembling the FDA-approved model.

At last, in response to a public outcry, including petitions, the FDA relented and now imported masks can be used. The FDA further announced that it might consider expedited approvals—but don’t forget your paperwork! This may be the correct mindset for a study hall proctor, but not for an agency that has enormous power over our medical supply.

There is a solution:

The quickest way to get effective tests and masks to hospitals and the public—and to sort out the ineffective ones—is to rely on the free market’s vast pool of decentralized knowledge. Consumers routinely buy products more complex than tests or masks without relying on a federal guarantee of effectiveness.

Researchers, doctors, hospital administrators, manufacturers, merchants, and consumers can process and share far more information than any agency in Washington, and they can do it a lot more quickly—especially in a pandemic.

I don’t expect the pandemic to revolutionize our lives to the extent that many are predicting (unless we fail to open the economy until too much rot has set in), and I feel certain that we will be debating transgenders on girls’ basketball teams before you know it.

But the pandemic does seem like it offers a chance to address the reliance on esoteric regulations that kill people. The pandemic was not spring time for bureaucrats.

Read Tierney’s entire article.