HHS calls on FDA to speed up reviews of lab-developed COVID-19 tests after backlog

Drive thru coronavirus testing
The Department of Health and Human Services directed the FDA to speed up the approval of lab-developed COVID-19 tests to shield the labs from liability. (Image: Getty Images)

The Food and Drug Administration (FDA) will speed up the approval of laboratory-developed COVID-19 tests developed by universities and hospital systems, Trump administration officials said.

The agency will get help from the National Cancer Institute (NCI) to review applications for emergency use authorizations for tests if it takes more than 14 days to issue emergency approval, said Admiral Brett Giroir, M.D., assistant secretary for health at the U.S. Department of Health and Human Services (HHS), during a call with reporters Monday.

The new guidance comes after lawmakers complained about the amount of time it has taken for the FDA to grant emergency approval for laboratory-developed tests (LDTs).

The Trump administration has asked universities to develop their own tests to help test students, faculty and staff. University health systems and some hospital systems have also developed their own tests.

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The LDTs have to be manufactured in a single lab and they do not require a review by the FDA to reach the market.

There is a catch, though.

“Without an [FDA emergency use authorization], although the test can be used, it cannot receive liability protection by the [Public Readiness and Emergency Preparedness] Act,” said Giroir, who is coordinating the COVID-19 testing effort.

Lawmakers such as Sen. Amy Klobuchar, D-Minnesota, have raised concerns about the lack of liability protections for the unapproved tests.

HHS directed FDA to make any review of an LDT completed within 14 days. If the review takes longer, the NCI will step in to help, Giroir said. “Nobody can question the scientific integrity of the National Cancer Institute,” Giroir added.

He said that it is primarily LDTs from universities being held up by the FDA.

“If it is a health system that will have a major amount of testing, we think FDA will triage them higher in the stack anyways because of the public health impact,” Giroir said.

Some hospitals and university-affiliated medical centers turned to developing tests in-house after a major delay in getting results at the onset of the pandemic back in March.

Giroir gave an update on the administration’s efforts to shore up testing capacity as COVID-19 has surged across the country. He said that the administration is responding to any state that wants to set up federally run surge testing sites.

This week, the agency plans to distribute more than 8 million tests, including 1.9 million to nursing homes and nearly 4 million to states.