Late last month, the Biden administration announced a new initiative to lower the cost of at-home Covid-19 tests and make them more widely available.
It’s long past time. Throughout the pandemic, bureaucratic sclerosis has proven the American regulatory apparatus to be an impediment to fighting Covid-19—not to mention future public health threats.
Recall that in the early days of the pandemic, the Centers for Disease Control and Prevention was tasked with responsibility for manufacturing and distributing a successful Covid-19 test. Other private and public labs were discouraged—or even forbidden—from creating their own tests.
The CDC’s test infamously failed to correctly identify cases one out of every three times. The agency was aware of the problem. But it still distributed the faulty tests to state labs across the country.
When other labs recognized the fault, they asked for permission to begin making their own tests. The FDA—which claimed sole authority over approving tests at the beginning of the pandemic—denied their requests over fear of false negatives.
The FDA’s perverse preoccupation with perfection — in the face of a historic public health crisis—has made it nearly impossible for manufacturers to navigate the agency’s approvals process for the duration of the pandemic.
For example, the FDA has required at-home rapid tests to meet the same regulatory standards as lab-based tests. It’s true that laboratory tests are better at picking up very low levels of Covid-19. But if people routinely test themselves, studies show rapid tests can detect 98% of Covid-19 cases.
The FDA has also refused to accept trial data from studies conducted in other countries. In one instance earlier this year, the agency denied a company’s application because some of its trials were completed in Europe. Other companies have withdrawn their applications because they “heard” their data wouldn’t be accepted, according to a new ProPublica report.
As a result, there are just a dozen over-the-counter tests authorized in the United States. By contrast, there are nearly 40 authorized for use across the European Union. One of them, manufactured by San Diego-based Acon Laboratories, has been available in Europe for over a year but was just approved by the FDA last month.
It’s not for manufacturers’ lack of trying. The ProPublica report revealed that testing companies face an “arbitrary, opaque [FDA approvals] process that meanders on, sometimes long after their products have been approved in other countries that prioritize accessibility and affordability over perfect accuracy.”
One test-maker told ProPublica it submitted data on its test back in March. After requesting more data and waiting months to respond, the FDA informed the company it wouldn’t review the rest of the application. At the same time, the manufacturer was fielding large orders for its tests in Mexico and Europe.
That company’s experience isn’t unusual. An analysis of the FDA’s approvals process found that the median number of days it took for the agency to issue an emergency use application decision was 99 days in November 2020. In March 2020, the median review time was just 14 days.
In other countries, the sheer volume of tests on the market has lowered costs and increased availability. In the United Kingdom, Brits can order a new pack of tests online each day at no cost. Germans can find tests at their local grocery stores for just $1.
That’s not the case in the United States. Pharmacy shelves that once held over-the-counter tests are bare. When consumers can find a rapid test, they’ll pay anywhere from $7 to nearly $40 per test. Using a typical over-the-counter test twice a week would cost more than $1,000 per year for American consumers, according to a Kaiser Family Foundation analysis.
That cost could become a part of everyday life under new guidance from the Biden administration, which will require unvaccinated staffers at companies with 100 or more workers to undergo weekly testing starting next year. The U.S. Court of Appeals for the Fifth Circuit issued a ruling on Saturday, November 6, stopping this mandate that these workers get vaccinated or submit to weekly testing. It seems likely that an appeal from the Biden administration will be coming soon.
But the lack of access to at-home tests has a human cost, too. Last year, Harvard epidemiologist Dr. Michael Mina estimated that the availability of rapid testing would have saved more than 100,000 American lives between June 2020 and December 2020.
The federal government’s move to expand access to rapid Covid-19 tests is too little, too late for tens of thousands of Americans. And the FDA deserves a significant amount of the blame.