FDA Offers 'Unprecedented' Leeway For Coronavirus Tests

Law360 (March 16, 2020, 11:21 PM EDT) -- Aiming to jump-start sluggish screening for the deadly new coronavirus, the U.S. Food and Drug Administration late Monday said it would allow medical device makers to distribute unapproved diagnostic tests and allow states to unilaterally authorize lab tests.

The FDA laid out its new leeway in a 14-page guidance document and said that its relaxed oversight represents an "unprecedented policy" intended to tackle the "urgent public health concerns" of the coronavirus, which is sweeping the globe and causing a severe respiratory disease called COVID-19.

FDA Commissioner Stephen Hahn, speaking with reporters late Monday, predicted that the announcement will foster "a surge [of test availability] to meet the demand that we expect to see, although it is somewhat difficult to quantitate."

About 25,000 coronavirus tests haven been performed in state and federal labs in the U.S. The figure, which doesn't include private labs, is a far cry from the number of tests reportedly performed in a number of other countries, including China, South Korea and Italy. Roughly 4,000 Americans have tested positive for the coronavirus, but the true number of infections could be much bigger.

The FDA in recent days cleared tests developed by Roche AG and Thermo Fisher Scientific, and President Donald Trump predicted Friday that the U.S. would hit 5 million tests within a month. Monday's announcement — which was accompanied by new emergency authorizations for tests sold by Hologic Inc. and LabCorp — could mark an important step toward that target.

One key element of Monday's action by the FDA will build on deference that the agency last week granted to New York by permitting all states to clear laboratory tests for the coronavirus.

"States can set up a system in which they take responsibility for authorizing such tests, and the laboratories will not engage with the FDA," the agency said Monday.

A second significant step will allow medical device makers to distribute tests, and labs to utilize them, without waiting for a so-called Emergency Use Authorization from the FDA.

"During this public health emergency, the FDA does not intend to object to the distribution and use of these tests," the agency said, explaining that a 15-day grace period will be granted for companies to seek emergency authorizations after distributing tests.

Monday's guidance also contained latitude for the distribution of unapproved serological tests that detect antibodies to the coronavirus. Those tests are less complex, and the guidance cautioned that "negative results do not rule out" a coronavirus infection.

The dearth of testing in the U.S. has meant that diagnostic screening in many places has been limited to patients with serious symptoms of COVID-19, which is initially characterized by fever, cough and difficulty breathing. Where testing is available, it is sometimes being performed in drive-through settings that have attracted hourslong waits in long lines of cars.

"A public health emergency like this is constantly evolving," Hahn said Monday, adding that the FDA's "response is adapting as the public health emergency continues to evolve."

--Editing by Jill Coffey.


For a reprint of this article, please contact reprints@law360.com.

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