The announcement – which one expert said was part of a “bureaucratic fight” between HHS and FDA – states that the FDA does not require a premarket evaluation of laboratory-developed tests and this move is “part of HHS’s ongoing department-wide review. of regulatory flexibility introduced since the launch of COVID-19. “
Prior to this announcement, laboratories had submitted applications for authorization for emergency use to develop and use their own Covid-19 tests. The HHS announcement notes that labs seeking FDA approval, approval or authorization for emergency use for their testing may pass this on, but these are not required.
“Those who choose to use LDTs in their laboratories without FDA premarket evaluation or authorization may do so with the understanding that they would not be eligible for PREP law approval, clearance or authorization and will remain subject to regulation by the Centers for Medicare & Medicaid Services under the 1988 Clinical Laboratory Changes Improvements, “the announcement said.
HHS also notes that those with an active emergency use authorization use for a laboratory test designed to detect the coronavirus that has left Covid-19, as its antibodies, unaffected by the new announcement.
Some health experts have applauded this move by HHS, while others have expressed concern about what it could mean for Covid-19 test accuracy.
Some cheers and some worries
“It basically says you don’t have to worry about an EUA. We can go back to lab-developed tests for coronavirus without the regulatory hurdle that the FDA needed early on,” said Dr. Amesh Adalja, senior scientist at the Johns Hopkins University Center for Health Security.
“This is, for me, good guidance, because it actually fixes that problem that no one really predicted early on, which is when you declare a public health emergency in general, most people think that removes barriers to testing, but it increased testing actually when it came to Covid-19, “said Adalja. “Now this is basically a restoration of that whole bureaucratic language that made that problem in that beginning.”
But Art Caplan, a professor and founding head of the division of bioethics at NYU Langone Health in New York, said he was concerned about this HHS movement.
“It seems that there is a kind of bureaucratic battle between HHS and FDA. HHS did not have to choose this fight, and they are in principle threatening the science and independence of FDA. In other words, they stepped in and said: ‘You can’ Arrange this test because of a technicality. ‘ They don’t have to do that, “Caplan said.
“So I worry about what that means for the accuracy of these lab tests. In principle, these are things that are done in individual labs – almost like boutique tests – and then you have a concern that they will not 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 bigger – it’s better.”
The FDA declined to comment.
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