The Trump administration has lifted some regulatory requirements for coronavirus tests, which officials say will allow more tests to enter the market.
The regulatory change announced this week will increase flexibility to make coronavirus tests developed by commercial labs such as Quest Diagnostics and LabCorp more accessible to the public. The legal team at Health and Human Services decided to scrap a rule that the FDA issued when the public health emergency began, which would have required labs to submit tests for the lengthy approval process before making them available for public use.
HHS determined that the FDA’s rule was a regulatory hurdle that held up the introduction of more coronavirus tests. The FDA did not go through the right process to gain authority to approve lab-developed tests before introducing them to the market, a process that allows the public to comment on the proposed regulation. The change was based on legal considerations rather than policy goals, the senior administration official said.
“This deregulatory action ensures compliance with law, is responsive to multiple Trump Administration Executive Orders … and better prepares us for future pandemics while maintaining regulatory safeguards for quality and accuracy,” Brian Harrison, Chief of Staff at HHS, told the Washington Examiner in a written statement.
The rule change, made late into the pandemic, has made some public health experts fear that inaccurate coronavirus tests will make their way into the market, the Washington Post reported. Frank Pallone, chair of the House Energy and Commerce Committee, which oversees the FDA, called the change “deeply concerning.”
“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. … 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.’”
An FDA spokesperson declined to comment on the matter and referred all questions to HHS.
“All COVID-19 tests in the United States will still be regulated at the federal level,” Caitlin Oakley, a spokeswoman for Health and Human Service, told the Washington Examiner. “Even after this change, there are no unregulated COVID-19 tests in America.”
Most of the diagnostic tests currently in use, such as the one by Abbott, are developed by medical device manufacturers and must go through the FDA for approval.
This article has been updated to clarify the change made by the HHS.
