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Wednesday, July 6th, 2022

HHS decision to allow COVID-19 tests to market without FDA review provokes Congressional backlash

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The U.S. Department of Health and Human Services (HHS) announced last week the cancellation of Food and Drug Administration (FDA) requirements on premarket reviews for lab-developed tests linked to COVID-19.

Pitching the change as one targeting unnecessary policies and increasing flexibility in the face of the pandemic, the department stripped the FDA of a common safeguard on new items.

“Those seeking approval or clearance of, or an emergency use authorization (“EUA”) for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions,” the HHS said in a statement. “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.”

The move sparked an immediate response from House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), who accused the Trump administration of interfering with the FDA’s regulation of medical products. He demanded a briefing from HHS Secretary Alex Azar regarding the change and an explanation for why HHS would make such a drastic change during the pandemic, as the need for accurate tests grows.

“Given the importance of testing for our ability to control the spread of COVID-19 and the Administration’s past blunders with serological tests, I do not believe that now is the time to reduce oversight of COVID-19 tests,” Pallone said. “The Trump Administration has continuously failed to grasp the scope of this pandemic. Flooding the market with unregulated and potentially inaccurate tests will only further undermine our nation’s response efforts. As FDA has repeatedly stated, inaccurate lab-developed tests present a higher risk during a public health emergency and ‘should not be used for clinical diagnoses without FDA’s approval, clearance, or authorization.’”

Whether this yields a response from the administration remains to be seen, however. A previous letter to the FDA on work to determine COVID-19 test accuracy went unanswered. The Energy and Commerce Committee dispatched that letter in July.