Former FDAer Says Allowing Developers to Self-Validate COVID-19 Tests Led to Chaos

Former FDA Chief Scientist Jesse Goodman told a House subcommittee hearing that the FDA’s decision to allow diagnostic test developers to self-validate their COVID-19 products caused a flood of unqualified products on the market.

“FDA unfortunately opened the door to widespread marketing of COVID-19 serology tests by commercial manufacturers, essentially without any review, regulatory framework or control,” Goodman said in a June 9 hearing before the House Committee on Oversight and Reform.

“The chaos that ensued demonstrates why we have an FDA to ensure our medicines and diagnostics are safe. Both qualified and unqualified entities flooded the market,” he said. Goodman noted that many of the faulty tests are now being withdrawn due to poor sensitivity or specificity. “This shouldn’t have happened,” he said, stressing the need for better quality control.

Rep. Raja Krishnamoorthi (D-Ill.), chairman of the House Subcommittee on Economic and Consumer Policy, said the agency should accelerate its review of serology tests on the market and recall those that don’t work, calling them “junk tests.”

Krishnamoorthi sent a letter in April to FDA Commissioner Stephen Hahn and CDC Director Robert Redfield, voicing his concern over the FDA’s handling of COVID-19 serology tests.

In March, the FDA announced a new policy for diagnostic tests for the coronavirus, which allowed companies to market tests while they prepared their Emergency Use Authorization (EUA) applications and during FDA’s subsequent review. However, the FDA said that approval wouldn’t be necessary for serology tests. Rather, the agency would allow clinical laboratories and manufacturers to develop and distribute serology tests, provided that the manufacturer validated the test (IDDM, April 15).

Krishnamoorthi noted in the letter that the FDA was not requiring an EUA submission for serology tests unless they are intended as “the sole basis to diagnose or inform infection status.”

In April, the agency announced that more than 50 manufacturers and labs had notified the FDA of validated serology tests, and that they would not be pursuing EUAs. At this point, companies began to market the products, with some even selling them directly to consumers as home test kits.

Public health professionals raised red flags about the tests, many of which were manufactured in China, and posed risks of inaccuracy, Krishnamoorthi said during the hearing.

Krishnamoorthi said the subcommittee was pleased with the direction the agency is now taking, as it now requires EUAs for all tests. But he said that there were still many tests on the market that the FDA has not reviewed, pressing the agency to “complete its review quickly, recall junk tests and ensure that people only use quality tests for the right purposes.”