FDA

Why the Hell Has the FDA Not Approved Cheap Rapid COVID-19 Self-Tests Yet?

If they're good enough for Europeans, surely they're good enough for Americans.

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Above is a photograph of my stash of five at-home COVID-19 tests. After participating a conference in South Dakota in July where a lot of folks were ostentatiously unvaccinated, I used one so that if I tested positive I could quarantine myself to prevent infecting other people. Since I have been fully vaccinated since early March, I hoped that the results would be negative. Fortunately, they were. The cost of my test stockpile is $149.95.

Below is a photo showing a bin of at-home rapid Flowflex COVID-19 tests for sale for about $3.50 apiece at a supermarket in the Netherlands. The test is manufactured by a company headquartered in the U.S., but the Food and Drug Administration (FDA) has not approved it for sale here. In the bin below the Flowflex test, you'll see another COVID-19 self-test offered by Roche. You can buy it in the Netherlands for about $5.90 per test. It too is not approved by the FDA.

The picture was tweeted by the Tufts Medical Center pediatrician Mark Dexter, who quite reasonably observes, "I don't understand why we *still* don't have these in the US!"

The answer is simple: From the beginning of the pandemic 20 months ago, hypercautious federal bureaucrats have massively bungled COVID-19 diagnostic testing. Way back in March 2020, I argued that the FDA should get out of the way of rapid at-home COVID-19 testing. Instead, the agency prevented private companies and academic labs from developing and deploying any COVID-19 tests. It especially took its sweet time approving at-home diagnostic tests. The first real at-home COVID-19 wasn't finally approved until mid-December.

Making cheap, fast COVID-19 self-testing widely available could have dramatically reduced cases and deaths and enabled Americans to safely work, shop, travel, and entertain themselves just a few months into the pandemic. Bureaucratic incompetence ensured that this didn't happen.

Demand for the expensive at-home COVID-19 tests approved by the FDA has outstripped in-store supplies as delta variant infections surged. Even at this late date, rolling out cheap rapid self-tests could significantly reduce transmission of the virus. If cheap rapid COVID-19 self-tests are good enough for Europeans, surely they are good enough for Americans.