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The FDA Graveyard

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eye on the news

The FDA Graveyard

Absurd bureaucratic strictures are hindering efforts to fight Covid-19. April 8, 2020
Covid-19
Politics and law

Critics of the Food and Drug Administration were long ignored as they tallied up the casualties in the “invisible graveyard” of Americans who died because of the FDA’s antiquated policies. But now one small part of that graveyard has suddenly become visible—and the need for reform has become glaringly obvious.

Americans are dying daily because of FDA regulations that have repeatedly delayed testing for the Covid-19 virus and impeded the manufacture and deployment of masks and other protective equipment. The agency’s obstructionism has angered the public—and prompted a search for scapegoats at the FDA and the White House—but there’s nothing unusual about these deadly delays. They’re an inevitable consequence of the FDA’s rules and its charter to allow only medical treatments and devices that its cautious bureaucrats have decreed to be “safe and effective.” This philosophy is conservatively estimated to be responsible for tens of millions of deaths of people waiting for the FDA to approve treatments for cancer, heart disease, and other ailments.

FDA officials insist that they’re moving during the pandemic at unusually rapid speed—and, unfortunately, that’s true. The pandemic simply reveals how lethal red tape can be, even when the agency’s leaders are trying to cut it. The debacle isn’t due to any one person or one mistake, but rather to the welter of esoteric regulations that have continually slowed the battle against the virus for the past three months.

In mid-January, a German test for identifying the virus was distributed by the World Health Organization and used in other countries to confront the pandemic early. American doctors could not use the test because it hadn’t received the imprimatur of the FDA, which instead authorized another test from the Centers for Disease Control. That test took longer to develop and proved faulty.

That was just the first of many obstacles. When researchers in Seattle tried doing early testing on their own in February, they were ordered to stop because their lab wasn’t federally certified and they hadn’t used the proper consent forms in collecting samples. As the researchers scrambled to get emergency approval, they were delayed for weeks by anachronistic rules, like the refusal to accept an emailed application because it needed to be submitted on paper, by mail, along with a copy on a compact disk or a plug-in computer drive.

It wasn’t until mid-March that the FDA, under White House pressure, finally gave private labs emergency dispensation to provide tests without the agency’s prior approval. But then it put up a new roadblock, when several companies launched tests (which they said were being sold at-cost, with no profit) for consumers to use at home. The FDA promptly declared that its emergency dispensation didn’t apply to at-home tests, forcing the companies not only to stop selling the tests but also to destroy the samples they had collected.

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.

Finally, as the shortages at hospitals worsened and as public petitions called for a change in policy, the FDA announced last Friday that it would allow the Chinese masks to be imported. It also tossed a bone to companies hoping to switch their factories to producing masks, announcing that the agency “may consider expedited review” of their plans if they submit the right information.

To a bureaucrat, that apparently qualifies as a bold gesture: the agency may, if you submit the proper paperwork, consider speeding up its review. To a non-bureaucrat, it’s evidence that something is fundamentally wrong. Why, as health-care workers and the public are desperate for tests and masks, can’t the FDA just get out of the way?

Its leaders insist that they’re just doing their job—but that’s precisely the problem. Their job is predicated on the assumption that only the FDA’s experts know enough to protect Americans against shoddy medical treatments and devices. That was a dubious assumption when the FDA was empowered in 1962 to determine what is “safe and effective,” and it’s hopelessly archaic now that health-care providers and patients have instant access to a digital cornucopia of information.

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.

Photo by David Dee Delgado/Getty Images

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