FDA policy will expand viral testing

WASHINGTON — The Food and Drug Administration on Saturday took new steps to expand testing for the coronavirus by speeding up hospitals’ ability to test for the virus. The action followed complaints from hospital laboratories that the previous policy was too burdensome and was slowing their efforts to create and use their own tests.

Certified hospital labs typically can develop their own tests for in-house use, but the rules of a public health emergency — which are now governing the coronavirus outbreak — mean those tests first need to get “emergency use authorization” from the FDA. Lab officials have repeatedly said the FDA’s emergency use requirements are too onerous.

Experts have warned that the small number of U.S. cases so far may be a reflection of limited testing, not of the virus’s spread.

Under the policy announced Saturday, the labs can begin using their own tests after validating them and before the FDA has finished reviewing their request for emergency use authorization.

“We believe this policy strikes the right balance during this public health emergency,” said FDA Commissioner Stephen Hahn in a statement. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S.”

He said the agency wasn’t changing its standards for issuing emergency use authorizations, but that it was addressing “critical public health needs” and responding to a “dynamic and evolving situation.”

But Melissa Miller, director of the clinical microbiology laboratory at the UNC School of Medicine, said the change fell short. “To still have to file the EUA is disappointing,” she said.