Bureaucracy Stands in the Way of Widespread Testing
A quick, cheap, and widely available test for the coronavirus has long been seen as a key way to combat the disease’s spread. Such tests could be deployed in sizable numbers. But the bottleneck that has prevented them from reaching wide public use: the FDA bureaucracy.
As Reason’s Ron Bailey notes:
The good news is that a number of companies, including biotech startup E25Bio, diagnostics maker OraSure, and the 3M Co., are working on and could quickly deploy rapid at-home COVID-19 diagnostic tests. These antigen tests work by detecting, within minutes, the presence of coronavirus proteins using specific antibodies embedded on a paper test strip coated with nasal swab samples or saliva. Somewhat like at-home pregnancy tests, the antigen tests change color or reveal lines if COVID-19 proteins are recognized.
But there is one major problem. “Everyone says, ‘Why aren’t you doing this already?’ My answer is, ‘It is illegal to do this right now,'” Harvard epidemiologist Michael Mina told The Harvard Gazette in August. “Until the regulatory landscape changes, those companies have no reason to bring a product to market.”
It took Food and Drug Administration regulators until July to finally issue the agency’s template for approving tests that “can be performed entirely at home or in other settings besides a lab” and without a prescription.
A testing network that can quickly, and at very low cost, identify potential hotspots before they become serious problems would go a long way to helping curb infection – and allow more people to safely get back to work, school, and much more. That bureaucratic foot dragging is standing in the way is unconscionable.