Just about a year after the first wave of coronavirus-related lockdowns, the Food and Drug Administration (FDA) has greenlit two vaccines: Pfizer and Moderna. And, just recently, Johnson & Johnson’s vaccine was also approved under emergency use authorization (EUA). The speedy approval schedule has stunned regulatory experts who have come to expect product approvals to take a decade or longer. But, as Americans wait to get shots in the arm, they must make do with a subpar testing regime that takes a day or longer to deliver results at considerable expense. The lack of rapid, reliable testing for COVID-19 reflects a dangerously uneven regulatory process that jeopardizes lives in the name of risk-aversion. To turn the page on this pandemic, the FDA must reverse its misguided aversion to life-saving coronavirus tests.
Since the start of the pandemic, public health experts have emphasized that vaccines are only one route to COVID-19 eradication. With widespread rapid testing, individuals could know that them, their friends, and their family are coronavirus-free before congregating with them. Unfortunately, it’s nearly impossible to find a non-prescription test to use at home quickly and easily. Since the novel coronavirus has reared its ugly head, the FDA has given EUA to more than 330 tests and sample collection devices, but only four at-home tests. And, three of four of those at-home tests require a doctor’s prescription prior to purchase. The lone product that doesn’t require a doctor’s note is a rapid test kit produced by Australian company Ellume. But at $30 per test, Ellume’s test is out of reach and impractical for most Americans. Prices would likely decline quickly if there were some competition in the consumer over-the-counter market.
Because of FDA’s insistence that Americans pay their doctors a visit before using tests (such as Lucira and Abbott Laboratories’ BinaxNow), the availability of more over-the-counter tests will unnecessarily be delayed. Any prospect of quick, preventative screening has gone out the window due to the agency’s inability to trust people or science. Harvard’s T.H. Chan School of Public Health epidemiologist Dr. Michael Mina notes, “It’s very, very unfortunate when our regulatory agency is, which is meant to help protect Americans, is really at the center of preventing Americans from getting tools that will help limit the spread of an infection like SARS-CoV-2 and COVID-19.” Dr. Mina has suggested ditching the current, prevailing concept of one-off testing when people feel ill, and instead mass-producing rapid tests for workers regularly going to at-risk locations such as nursing homes and healthcare facilities. But that won’t happen if the FDA retains its “bottleneck” on approving rapid at-home tests.
While the FDA’s stymying of non-prescription tests is maddening, it’s hardly surprising. The FDA is famously risk averse and, according to former employees, fears the blowback stemming from approving a product that malfunctions in full view of the press. Regulatory officials’ worst nightmare is a test that doesn’t perform as expected (perhaps due to consumer negligence) and patients infecting others based on false information. And it’s true, maybe some consumers will get confused without a doctor reciting how long to stick a swab up their nose and how long to stir the swab into the test vial (instead of consumers just reading the directions on the package). But this “lowest common denominator” logic effectively shuts out millions of Americans from access to a fast, affordable test they could use before seeing loved ones.
It’s long past time for the FDA to give Americans the tools they need to exercise caution and stop the spread. Millions of lives hang in the balance.