Slow FDA approvals of at-home rapid tests have prolonged the pandemic

The delta variant has wreaked havoc. This week, the U.S. reported a seven-day average of more than 146,000 daily cases . In total, COVID-19 has killed more than 660,000 Americans since the start of the pandemic.

Thankfully, the rate of increase appears to be falling in many areas, compared to the surges in July and August. But significant damage has already been done. Much of this carnage could have been avoided if the Food and Drug Administration had accelerated approvals of rapid at-home COVID-19 tests, which allow people to catch cases early and quarantine to avoid infecting others.

As of mid-September, U.S. regulators had conditionally authorized only six rapid “antigen” tests for over-the-counter use, according to a Kaiser Health News analysis. That’s far fewer than other countries, where dozens of different tests are widely available.

These regulatory delays deserve some blame for our current shortage of rapid tests. Many stores and online retailers are sold out. The tests that are in stock are considerably more expensive in the States. The popular BinaxNOW test made by Abbott costs about $24 per two-pack in America. In Germany, rapid tests are about $1 a piece , according to Kaiser Health News.

Other nations have made these tests a cornerstone of their COVID mitigation efforts. Germany, for instance, started providing citizens with at-home tests this past winter. It currently reports 10 new COVID-19 cases per 100,000 people each day, nearly one-fourth the U.S. rate of 45 per 100,000 people .

German officials plan to end the free testing program in October, due to the fact that nearly 70% of residents have received at least one vaccine dose. But citizens interested in purchasing tests can still do so at a marginal cost — at anywhere from one-half to one-tenth as much as they would in the United States.

“As long as these [rapid] tests are regulated as medical devices, the FDA has to regulate them not as critical public health tools, but as medical tools, with all of the onerous clinical trials that slow everything down 100-fold,” Harvard professor Michael Mina recently told KHN.

In other words, the FDA has made a conscious decision to keep rapid tests inaccessible. Americans are dying as a result. In a November 2020 analysis , Mina concluded that the quick approval and fast rollout of rapid tests could have saved 100,000 lives and increased U.S. GDP by up to $1 trillion between June and December 2020.

The pandemic isn’t over yet. It’s time for the FDA to authorize the many rapid tests that other regulatory bodies have already judged effective. Slow-rolling these approvals has cost too many American lives already.

Sally C. Pipes is president, CEO, and Thomas W. Smith fellow in Health Care 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.

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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