WASHINGTON, D.C. – The Trump administration is slashing regulations governing test development in a bid to ramp up screening for the coronavirus amid nationwide frustration with the slow pace of the effort.
The unprecedented steps by the Food and Drug Administration could boost testing capacity at some U.S. labs, but also complicate efforts to assure the accuracy of tests and track who receives them.
More than eight weeks after the first U.S. case of COVID-19 was detected, the U.S. still struggles to conduct mass screening and provide definitive figures on the number of people tested.
Late Monday, the FDA said state health departments could essentially begin self-regulating and approving tests developed by their government-run laboratories.
“What we’re saying is that state departments of health can act as a surrogate for FDA and that the information doesn’t need to come through FDA,” FDA Commissioner Stephen Hahn told reporters on a call.
Regulators also said major test manufacturers could begin rolling out new tests without FDA pre-authorization and instead submit their applications up to 15 days after launch. Officials acknowledged the implicit trade-off of the approach, which potentially sacrifices the accuracy of unregulated tests to speed up access.
“We believe this will be a surge to meet the demand that we expect to see,” Hahn said.
For weeks, administration officials have talked about shipping millions of tests to U.S. labs. But it's become clear those numbers have little bearing on the actual number of patients tested since most U.S. labs can process fewer than 100 samples per day. In the last week, the FDA approved the first coronavirus tests for “high-volume” laboratory systems, which are capable of processing thousands of results per day.