A few weeks ago, a ProPublica reporter decided to test his kids for COVID-19. They had the sniffles, and with a grandparent set to visit he wanted to minimize the risk that they were infectious.
This was the problem that quick, cheap COVID-19 tests were supposed to help fix. No need to go to a clinic or wait days for results. Just pick up a pack of tests at a local pharmacy whenever you want, swab your nose and learn within 15 minutes if you’re likely to pass the virus along.
So the ProPublican went to his neighborhood CVS, hoping to buy the required pack of two for $23.99. They were out of stock. Then he went to Rite Aid. They didn’t have the tests either. Then Walgreens, then another CVS. All out of stock. The only supplier with a few tests to offer was his sister, who happened to have a few tucked away.
It’s a familiar experience for many Americans. But not for people in Britain, who get free rapid tests delivered to their homes on demand. Or France, Germany or Belgium, where at-home tests are ubiquitous and as cheap as a decent cappuccino.
So why are at-home tests still so pricey and hard to find in the United States?
The answer appears to be a confounding combination of overzealous regulation and anemic government support — issues that have characterized America’s testing response from the beginning of the pandemic.
Companies trying to get the Food and Drug Administration’s approval for rapid COVID-19 tests describe an arbitrary, opaque process that meanders on, sometimes long after their products have been approved in other countries that prioritize accessibility and affordability over perfect accuracy.
After the FDA put out a call for more rapid tests in the summer of 2020, Los Angeles-based biotech company WHPM, Inc. began working on one. They did a peer-reviewed trial following the agency’s directions, then submitted the results this past March.
In late May, WHPM head of international sales Chris Patterson said, the company got a confusing email from its FDA reviewer asking for information that had in fact already been provided. WHPM responded within two days. Months passed. In September, after a bit more back and forth, the FDA wrote to say it had identified other deficiencies, and wouldn’t review the rest of the application. Even if WHPM fixed the issues, the application would be “deprioritized,” or moved to the back of the line.
“We spent our own million dollars developing this thing, at their encouragement, and then they just treat you like a criminal,” said Patterson. Meanwhile, the WHPM rapid test has been approved in Mexico and the European Union, where the company has received large orders.
An FDA scientist who vetted COVID-19 test applications told ProPublica he became so frustrated by delays that he quit the agency earlier this year. “They’re neither denying the bad ones or approving the good ones,” he said, asking to remain anonymous because his current work requires dealing with the agency.
FDA officials said they simply want to ensure that rapid tests detect even low levels of the virus, since false negative test results could cause people to unwittingly spread the disease. They blame the test shortages on an absence of the kind of sustained public funding that European governments have provided. Without it, manufacturers have lacked confidence that going through the FDA’s process would be financially worth the trouble.
“Where we have seen tests truly coming to the marketplace, the big difference has been government investment,” said Dr. Jeff Shuren, head of the FDA’s Center for Devices and Radiological Health, which authorizes tests. “Folks will come and do larger volumes because you’re supporting production, which can also help drive down prices.”
Both the Trump and Biden administrations banked on vaccines putting a swift end to the pandemic, holding off on large-scale purchases of COVID-19 tests that Americans could keep in their medicine cabinets.
As a result, one of the few companies that has successfully gotten tests authorized and onto shelves — Abbott Laboratories — has dominated the market. Its BinaxNOW tests account for around 75% of U.S. retail sales, according to data from NielsenIQ, even though they’re sold here for several times the price of the same Abbott tests in Europe.
In the past two months, the Biden administration has taken steps to make home tests more widely available. As more tests are authorized and more purchase orders are signed, pharmacy shelves are starting to fill up.
But that still may not be enough, as manufacturers scramble to build supply chains capable of delivering the tens of millions of tests per week that public health experts estimate will be necessary to keep schools and workplaces open and safe. Employers charged with testing their entire workforces have found themselves in bidding wars in order to secure adequate supply.
As with the slow ramp-up of lab testing at the beginning of the pandemic, the delays have come with a cost.
“It feels like in one place we’re in a rocket ship and in another place we’re on training wheels,” said Rep. Kim Schrier, D-Wash., contrasting vaccines and testing. Schrier, a former pediatrician who has been pushing the agency to authorize more rapid tests, said, “You can’t count on the free market during a pandemic.”
The U.S. testing response has been troubled from the beginning of the pandemic, seesawing between caution and overcorrection.
In February 2020, the Centers for Disease Control and Prevention took weeks to develop its own test, which later turned out to have falsely flagged other viruses, allowing the one that causes COVID-19 to gain a foothold in the U.S.
Then the FDA became more permissive, allowing privately developed tests that detected antibodies from previous infections to enter the market after only cursory review. When dozens of the tests turned out to be inaccurate, the FDA prohibited their use.
Meanwhile, the FDA grappled with thousands of applications for “emergency use authorizations,” or EUAs. The process for EUAs is less involved than for full approval but still requires extensive clinical and real-world evaluation. Most EUAs issued have been for PCR tests, which are highly sensitive — meaning they can detect even low levels of the virus — but typically take days to return results.
Another form of diagnostics, antigen tests, can return results quickly and cheaply, similar to a pregnancy test. They’re less sensitive, but usually good enough to determine whether someone is infectious.
Recognizing the potential market for antigen tests, companies began submitting more EUA applications in late 2020. But the FDA was wary about this type of test, mostly warning of the danger of false negatives in the earliest stages of infection.
FDA officials were particularly concerned about allowing tests to be administered outside the purview of a trained health care provider. “To mitigate the impact of false results, all Covid-19 tests authorized to date have been made available only by prescription, so that clinicians can interpret results for patients,” wrote Shuren and his deputy Dr. Tim Stenzel in an October 2020 column in The New England Journal of Medicine.
That cautious approach persisted all through the winter and early spring, despite rising agitation from the White House and Congress around the availability of tests.
“I actually have been saying that for months and months and months, we should be literally flooding the system with easily accessible, cheap, not needing a prescription, point of care, highly sensitive and highly specific” tests, White House chief medical advisor Dr. Anthony Fauci said under questioning from Schrier in a hearing on March 17.
Stenzel, a microbiology Ph.D. who in 2018 became director of the office that authorizes diagnostic tests, holds the most day-to-day power over whether a test gets approved. He worked at biotech companies for most of his career before coming to the FDA, leading some to wonder if those prior relationships played a role in determining which testmakers became the most important players in the market.
Among Stenzel’s former employers were Abbott and the San Diego-based Quidel Corporation, the first two companies to sell self-administered, prescription-free COVID tests in large volumes.
Quidel CEO Doug Bryant said in a promotional video that in early 2020, the company wasn’t planning on designing a COVID-19 test until he got a call from a trusted contact at the FDA. That contact was Stenzel, the agency confirmed.
Quidel and Abbott had their at-home tests approved about a year later. On an earnings call, Quidel’s Bryant said it was “the most significant inflection point for our company.” In the third quarter of 2021, Quidel made $406 million from its various COVID-19 tests, blowing past Wall Street’s expectations. “There is no denying Quidel has put itself in position to win big in COVID-19 testing,” wrote an analyst with the firm William Blair. Abbott made $1.9 billion globally on its COVID-19 tests.
Ethics disclosures show that Stenzel holds no Abbott or Quidel stock, and it’s been several years since he worked at either company. But Stenzel’s ties to the two major test manufacturers and the slow pace of authorizations for other companies’ at-home tests drew a letter from an anti-monopoly think tank, the American Economic Liberties Project, calling for an investigation.