The announcement — which one expert said was part of a “bureaucratic fight” between HHS and FDA — states that the FDA will not require premarket review of laboratory developed tests and this move is “part of HHS’s ongoing department-wide review of regulatory flexibilities enacted since the start of COVID-19.”
Prior to this announcement, laboratories submitted emergency use authorization applications to develop and use their own Covid-19 tests. The HHS announcement notes that labs seeking FDA clearance, approval or emergency use authorizations for their tests can continue to do so but are not required to.
“Those opting to use LDTs in their laboratories without FDA premarket review or authorization may do so with the understanding that they would not be eligible for PREP Act coverage absent approval, clearance or authorization and would remain subject to regulation by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments of 1988,” the announcement said.
HHS also noted that those with an active emergency use authorization for a laboratory developed test to detect the coronavirus causing Covid-19, or its antibodies, are unaffected by the new announcement.
Some health experts have applauded this HHS move while others have expressed worry about what it could mean for Covid-19 testing accuracy.
Some cheers and some concerns
“It basically says you don’t need to worry about an EUA. We can go back to laboratory developed tests for coronavirus without that regulatory hurdle that FDA was requiring doing early on,” said Dr. Amesh Adalja, senior scholar at the Johns Hopkins University Center for Health Security.
“This is, to me, good guidance because it actually fixes that problem that nobody really foresaw early on, which is when you declare a public health emergency in general, most people think that removes barriers to testing, but it actually increased barriers to testing when it came down to Covid-19,” Adalja said. “Now this is basically rescinding that whole bureaucratic language that created that problem in the beginning.”
But Art Caplan, a professor and founding head of the division of bioethics at NYU Langone Health in New York, said he was worried about this HHS move.
“It looks like there is kind of a bureaucratic fight between HHS and FDA. HHS didn’t have to pick this fight, and they’re basically threatening FDA’s science and independence. In other words, they stepped in and said, ‘You can’t regulate this test because of a technicality.’ They didn’t have to do that,” said Caplan.
“So I worry about what that means for the accuracy of these lab tests. Basically, these are things that are done in individual labs — almost like boutique testing — and then you have a worry that they’re not going to be very accurate or that people will cut corners knowing that no one is looking over their shoulder to check their test,” Caplan said. “While testing is great, accurate testing is greater — it’s better.”
The FDA declined to comment.