FDA Policy Change Takes Aim at Coronavirus Test Shortages

(Bloomberg) -- Qualified labs will be able to develop and use their own coronavirus screening tests without waiting for an FDA authorization, under a policy change that aims to address test-kit shortages that have come under heavy criticism.

The Food and Drug Administration announced the move Saturday, hours after the Centers for Disease Control and Prevention announced four new cases of the COVID-19 coronavirus. Three of those cases indicate the virus is spreading through communities in the U.S. and is no longer isolated to travel-related cases.

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The latest cases, all on the West Coast, follow the two possible community-spread cases in California that the CDC announced earlier this week.

Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, said Saturday that problems with availability in testing are “rapidly being fixed.”

That will allow “many, many more tests out there so the health departments and even individual hospitals could be able to test much more easily with the results getting back much more quickly,” Fauci said on NBC's “The Today Show.”

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Under the new policy, labs that have been federally certified can make their own molecular diagnostics tests and use them without having to wait for the FDA to issue an emergency use authorization.

The tests must still go to the FDA for approval, but the agency is providing a 15-day grace period in which the labs can use the tests to screen patients while they get their submissions together.

New York Governor Andrew Cuomo said in a statement Saturday that the state's coronavirus test had been approved by the FDA and that testing would begin immediately at Wadsworth lab in Albany.

“We believe this policy strikes the right balance during this public health emergency,” FDA Commissioner Stephen Hahn said in a statement.

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“We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation,” Hahn said.

The CDC has faced criticism for delays and issues with its test, prompting groups like the Association for Public Health Laboratories to use their own laboratory-developed tests.

Nancy Messonnier, a top CDC official, said Friday the agency's in testing “has not gone as smoothly as well would have liked,” and that they're working on a few solutions, which Health and Human Services Secretary Alex Azar said would be out soon. Azar will speak Sunday on three U.S. political talk shows.

The sophisticated labs certified to run the tests are usually academic ones.

“We've needed more diagnostic capability for the coronavirus, and having our academic labs allowed to move forward can make those capabilities available more quickly at a time we need them,” Ross McKinney, an infectious disease specialist and chief scientific officer for the Association of American Medical Colleges, told Bloomberg Law.

To contact the reporter on this story: Jeannie Baumann in Arlington at jbaumann27@bloomberg.net

To contact the editors responsible for this story: Fawn Johnson at fjohnson36@bloomberg.net, Ros Krasny

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