When the history of the coronavirus pandemic is written, a chapter or three will have to be devoted to government failures. Not just the usual ones about messaging. But the bigger ones about preparation and response. It’s in areas like these that government failures percolated for years, going from embarrassing to fatal.
That includes vaccine preparedness, which has been on official Washington’s to-do list for decades. And, remarkably, testing for the latest coronavirus variants. Testing has come to the fore once again with the Omicron strain. And yet available testing to detect infection remains hit-and-miss.
Part of the reason? FDA bureaucracy, which is standing in the way of rapid tests. In one instance, a cheap, effective rapid test was developed back in March 2020. It is still awaiting FDA approval:
On March 21 — when the U.S. had recorded only a few hundred COVID-19 deaths — Bosch submitted the test for emergency authorization, a process the Food and Drug Administration uses to expedite tests and treatments.
A green light from the FDA could have made a big difference for the many Americans who were then frantically trying to find doctors to swab their noses, with results, if they were lucky, coming back only days later.
But the go-ahead never came.
In the months that followed, Bosch responded to repeated requests from FDA reviewers for data and studies. When the agency finally put out guidance that summer about the performance over-the-counter home tests needed to meet, officials required that such tests be nearly as sensitive as the lab tests used to definitively determine whether a patient has COVID-19.
That standard proved difficult to meet. Rapid tests are usually sensitive enough to detect viral antigens when someone has enough of them to be able to spread the disease. Such tests are not as good at picking up cases in either earlier or later stages of infection, when viral loads are lower.
Bosch’s tests missed the FDA’s high bar. It wasn’t until the spring of 2021 that much larger companies were able to design similar tests — relatively inexpensive, over-the-counter rapid tests — that the agency found acceptable.
“You could have antigen tests saving lives since the beginning of the pandemic,” said Bosch, sitting in her lab at MIT. “That’s the sad story.”
A sad story that has been allowed to play out for far too long, and at far too high a cost. If this was a one-off, it might be excusable. But it’s par for the FDA’s course:
…the miserable U.S. testing situation’s cardinal sin wasn’t a market failure; it was a regulatory one that—as past FDA rejections of at-home tests for pregnancy or HIV show—has been with us for decades.