The Trump administration will allow coronavirus testing developed by individual laboratories without using Food and Drug Administration (FDA) review, the administration announced Wednesday.
Amtners told Politico and the Washington Post that decision came after Health and Human Services (HHS) ruled that the FDA does not have the authority to regulate lab-developed tests for every condition, including COVID-19.
FDA officials have reported opposition to the move because some tests have been proven to be incorrect, but supporters say the FDA approval process hinders their ability to develop and release tests immediately.
The change in policy led to escalating tensions between HHS secretary Alex Azar and FDA commissioner Stephen Hahn, the Post reported. Hahn claims that an emergency such as a pandemic gives the FDA the authority to regulate laboratory tests.
HHS was also concerned about the FDA requiring emergency use authorizations for laboratory tests developed in February. The agency requested the authorizations during other public health emergencies, including the H1N1 pandemic in 2009 and the Zika outbreak in 2015 and 2016.
The agency allowed 35 authorizations for emergency use for lab-developed tests since this week.
Although lab-developed tests are widely used, most tests in the US are made by device manufacturers, who still need FDA approval to produce the tests.
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