Healthcare

Trump administration bars FDA review of some coronavirus tests

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The Trump administration will allow coronavirus tests developed by individual laboratories to be used without Food and Drug Administration (FDA) review, the administration announced Wednesday. 

Officials told Politico and The Washington Post that the decision came after the Department of Health and Human Services (HHS) determined the FDA does not have the authority to regulate lab-developed tests for any condition, including COVID-19.

FDA officials reportedly opposed the move as some tests have proven to be faulty, but supporters argue that the FDA approval process hampered their ability to develop and release tests promptly. 

The change in policy led to escalated tensions between HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn, the Post reported. Hahn argues that an emergency like a pandemic gives the FDA the authority to regulate laboratory tests. 

HHS was also concerned about the FDA requiring emergency use authorizations for laboratory-developed tests in February. The agency has required the authorizations during other public health emergencies, including the H1N1 pandemic in 2009 and the Zika outbreak in 2015 and 2016.

The agency has granted 35 emergency use authorizations for lab-developed tests as of this week.

Though lab-developed tests are in wide use, most tests in the U.S. are made by device manufacturers, who still must seek FDA approval to produce the tests.

Tags Coronavirus FDA Federal Drug Administration Health and Human Services HHS testing

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