This story was originally published by ProPublica.
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
, 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. Continue Reading
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