The FDA is standing in the way of at-home COVID-19 tests

The FDA is standing in the way of at-home COVID-19 tests

Earlier this month, President Joe Biden unveiled a plan to make at-home COVID-19 tests free for people with private insurance. They’ll have to pay for the tests first, then submit receipts to their insurer to get reimbursed.

Only the government could come up with a plan so unnecessarily complicated. The Biden administration defended the overly bureaucratic policy on the grounds of cost. But bureaucracy is one of the main reasons at-home tests have been so difficult to find in the first place. As of late November, the Food and Drug Administration had authorized just 14 at-home tests for emergency use. But the agency has received applications for many more. The FDA told Kaiser Health News last month that it had received more than 4,500 emergency use authorization and related requests for COVID-19 tests.

The cause of the backlog doesn’t seem to be a lack of resources. One FDA scientist who recently left the agency due to frustrations over delays said he could “easily process dozens of [applications],” according to ProPublica . He said he had “a lot of free time.”

Yet companies still wait months for a decision on their application. One at-home test maker told ProPublica it submitted its application in March of this year, provided more information to the agency in May, and then waited months before the FDA denied it in September.

An analysis of the FDA’s approvals process shows the company’s experience isn’t unique. In March 2020, it took the FDA a median of 14 days to issue an emergency use authorization decision. By November 2020, that number had risen to 99 days.

If the FDA had allowed more at-home tests to hit the market, competition would have driven prices down naturally, without government intervention. Unfortunately, the FDA took the opposite approach — and made it harder to fight COVID-19 in the process.

Sally C. Pipes is president, CEO, and Thomas W. Smith fellow in healthcare policy at the Pacific Research Institute. Her latest book is False Premise, False Promise: The Disastrous Reality of Medicare for All (Encounter 2020). Follow her on Twitter @sallypipes.