Trump’s FDA faces backlash for allowing ‘crappy’ COVID-19 tests to hit the market

The Food and Drug Administration is drawing criticism for allowing unreliable antibody tests on the market during the coronavirus pandemic.


The agency allowed more than 120 manufacturers and labs to market the tests, which look for antibodies that could indicate coronavirus exposure, with an FDA review, reported Politico.

"We're facing a public health epidemic," David Kessler, who led the FDA during the George H.W. Bush and Bill Clinton administration and currently advises Joe Biden on the coronavirus. "If FDA is not looking at validation studies, then FDA is not doing its job."

The FDA typically performs its own quality check before allowing tests on the market, but agency officials said they're trying to speed up the process for identifying who might be able to return to work and school.

But some public health experts say the tests are too "crappy" to determine who's been exposed to the virus.

"Ideally they would scrap the current policy and start over, but I don't think that's practical given this crisis,” said Scott Becker, CEO of the Association of Public Health Laboratories. “The best we can hope for is a rigorous and expansive evaluation."

The New York City Health Department warned medical providers last week that the tests were too unreliable to determine exposure or immunity to the virus.

FDA commissioner Stephen Hahn told Politico the agency has discussed a changing its policy, which allows manufacturers to validate their own tests as long as they include a disclaimer with the test results.

Hahn said emergency use speeds up the process for getting tests onto the market, but some say the agency was overcorrecting after the FDA was criticized as too slow to approve coronavirus tests early in the outbreak.