As governments misguidedly forced people to shut down their businesses and upend their lives because of the coronavirus pandemic, the Food and Drug Administration was actively blocking simple ways to save lives.
The federal bureaucracy stinks.
On Tuesday, the nonprofit ProPublica news organization published a comprehensive investigative story about how the FDA refused to approve over-the-counter, rapid tests for COVID-19 that could have made a world of difference. Presented to the FDA just two weeks into the pandemic panic, the tests later proved to identify the virus successfully in 80% of patients and apparently 100% of those most likely to be infectious to others. This is just one of the many instances in which experts blame the FDA for being too slow to respond to the pandemic.
Yet that’s par for the course. For more than a quarter-century, the FDA has come under fire from medical practitioners for being too slow in approving new drugs and devices. Described variously as “lax,” “secretive,” and absurdly inflexible, the agency has a lasting reputation for sclerosis. That’s why, for example, states and Congress have spent years passing “right to try” legislation allowing patients with apparently terminal cases to use promising, experimental drugs that the FDA has dragged its feet in approving.
To be fair, there’s good reason for caution in ordinary drug-approval cases. Many are the examples in which medicines once thought safe and effective for their desired ends later proved to be toxic in other ways. But “ordinary” is a far cry from “life-in-the balance” (as in “right to try” instances) and also far from an international emergency. Moreover, and most on point here, there’s a big difference between slow-walking an actual treatment whose side effects may be unknown and slow-walking a diagnostic tool that could convince people to seek treatment before they get markedly sicker and before they infect others.
That’s what was at issue with the proposed rapid test, one that could be made available for home use at less than $10 apiece, that correctly identified COVID-19 in 80% of the cases. The FDA’s reluctance to approve it is baffling. With the process for more accurate, doctor-administered tests being far more cumbersome, literally millions of people probably waited far too long to get tested at all, thus raising their own risk of hospitalization and the communal risk of adding to “superspreader” occurrences.
What would have been the harm, therefore, in helping millions get tested who otherwise wouldn’t be, even if 20% of those extra millions received “false negatives” (and a much, much lower percentage received “false positives”)? Eighty percent of millions is better than 0% of millions, right? Furthermore, the tests come in two-packs, with easy-to-understand instructions to A) re-test a “negative” result if symptoms don’t improve and B) report a “positive” test immediately to a doctor (who should prioritize positive-test cases) to confirm it with the gold standard: the so-called PCR test.
The FDA wasn’t keeping the public from a potentially dangerous treatment, but from accessing basic information. Why do bureaucrats never trust ordinary people with simple information or the ability to make decisions while following easy instructions?
As leading reformer Philip K. Howard has insisted in The Death of Common Sense and numerous subsequent books, bureaucracies should be made less rule-bound and risk-averse: “America needs to radically simplify its operating system and give people ― officials and citizens alike ― the freedom to be practical.” Especially in a crisis, common sense needs freer rein.
“You do what you can when you need to in an emergency,” one epidemiologist, lamenting the FDA’s blocking of the at-home rapid test, told ProPublica.
In this case, the FDA’s intransigence missed a chance to save perhaps up to hundreds of thousands of lives. The agency has long needed reform. That need is now urgent.
