Another U-turn for COVID-19 testing regulation as HHS requires FDA to re-prioritize LDT review
The latest switchback in the U.S.’s regulation of COVID-19 tests sees HHS requiring FDA to review tests it previously said the agency lacked authority over, highlighting the challenge of pursuing a deregulatory agenda in the midst of a pandemic.
On Monday, Assistant Secretary for Health Brett Giroir said HHS is directing FDA to review emergency use authorization (EUA) applications for laboratory developed tests (LDTs) within 14 days of submission; if the agency cannot complete a review in time, it will be conducted by NIH’s National Cancer Institute (NCI).
LDTs, which are developed and conducted by a single CLIA-certified laboratory, typically do not require FDA review. But the state of emergency declared for the pandemic in January gave FDA oversight over LDTs for COVID-19 via the EUA process, with the logic that inaccurate tests present a greater risk during a public health emergency.
In August, HHS posted a notice on its website saying FDA can no longer require premarket review of LDTs for COVID-19 unless it goes through a formal rulemaking process. The announcement cited President Donald Trump’s deregulatory policies, but did not cite any public health benefits; it also said LDT developers could voluntarily seek FDA review.
In response, FDA announced on Oct. 7 that it would decline to review LDTs “to make the best use of our resources for the greatest public health benefit,” raising concerns about both the accuracy of unreviewed tests, and the legal liability faced by the labs that developed them. Under the Public Health and Emergency Preparedness Act (PREP Act), labs have immunity from claims of loss related to their tests, but only if the the tests were authorized by FDA.
It was the latter concern that led HHS to direct FDA to reinstate reviews of LDTs.
The announcement marks the second instance of regulatory reversal for COVID-19 testing; in May, FDA said it would start reviewing COVID-19 serology tests after initially saying they could come on the market without regulatory review, so long as test developers conducted their own validation studies, notified FDA, and provided certain disclaimers.
It is also the third time NIH has assumed a major role in the development of COVID-19 tests.
In April, NCI stepped up to review COVID-19 serology tests, drawing on its experience evaluating serology tests for human papillomavirus (HPV) vaccines to prevent cervical cancer. The same month, NIH launched the Rapid Acceleration of Diagnostics (RADx) program to fast-track development of new COVID-19 tests.