FDA No Longer Required To Review Lab-Developed Coronavirus Tests

The FDA will no longer be able to require the review of laboratory-developed coronavirus tests, the Trump administration announced.

The announcement comes as the U.S. Department of Health and Human Services determined that the FDA does not have regulatory authority to approve lab-developed tests for any type of condition, including COVID-19, officials told The Washington Post and Politico.

“A review by the Office of the General Counsel found that the FDA’s assertion is on unfirm procedural and regulatory grounds,” an official told Politico. “They did not gain the authority to regulate LDTs by having gone through a notice and comment rulemaking period, which would be required for an assertion of authority like that.”

FDA officials are not in favor of the decision because they said that some tests can prove to be inaccurate without proper approval by the agency, The Hill reported. Others that support the move argue that the FDA delays the approval process of these tests and hampers quick release of these tests.

The decision by the Trump administration builds on tensions between HHS Secretary Alex Azar and FDA Commission Stephen Hahn, the Post said. Hahn has said that an emergency like a pandemic does give the FDA authority to regulate lab tests, which the agency has granted 35 emergency-use authorizations for as of this week, The Hill reported.

The U.S. has reported over 5.5 million positive cases of the coronavirus, with over 173,000 COVID-19 deaths, according to data from Johns Hopkins University.