August 21, 2020 at 12:27 AM EDT
Trump administration bars FDA from regulating some laboratory tests, including for coronavirus
The Trump administration this week blocked the Food and Drug Administration from regulating a broad swath of laboratory tests, including for the coronavirus, in a move strongly opposed by the agency.
The new policy stunned many health experts and laboratories because of its timing, several months into a pandemic. Some public health experts warned the shift could result in unreliable coronavirus tests on the market, potentially worsening the testing crisis that has dogged the United States if more people get erroneous results. They argued the change is unlikely to solve current testing problems, which at this point are largely due to shortages of supplies such as swabs and chemical reagents.
But supporters cheered the change as long overdue, saying it could help get new and more innovative tests to market more quickly. They said that the FDA review process sharply slowed testing at the beginning of the pandemic and that the new policy could ensure such bottlenecks don’t recur.
By Laurie McGinley and Yasmeen Abutaleb