Trump Lifts Lab Tests from Need to Get OK from FDA
HHS said 8/20 that under a Trump Administration deregulation initiative, FDA will no longer require premarket review of laboratory-developed tests (LDTs), including tests to detect the virus that causes Covid-19. It’s a major policy change made without notice and comment rulemaking. Attorneys Gail Javitt and Jeffrey Gibbs (Hyman, Phelps & McNamara) call the announcement “jaw-dropping” in a post in their firm’s FDA Law Blog.
The attorneys write that HHS said it made the decision as part of its ongoing department-wide review of regulatory flexibilities enacted since the start of the pandemic and said it was consistent with several executive orders. They note the department did not offer any further explanation for the abrupt shift and did not explain why the change was not extended to other FDA policies that the attorneys say “have increased regulation and regulatory costs for companies seeking to offer Covid-19 tests.”
As a result of the announcement, the post says, clinical laboratories will no longer be required to submit a request for emergency use authorization (EUA) before offering LDT-based testing for Covid-19. It says the change does not alter clinical laboratory obligations under the Clinical Laboratory Improvement Act.
According to the announcement, Javitt and Gibbs write, clinical laboratories may still voluntarily seek an EUA from FDA for Covid-19 tests, and laboratories that offer such LDTs without premarket authorization will not be eligible for coverage under the 2005 Public Readiness and Emergency Preparedness Act, which provides immunity from liability for losses related to medical countermeasures used to combat a declared public health emergency.
The attorneys conclude that the HHS announcement has “far-reaching implications for all clinical laboratories offering LDTs….”
Meanwhile, House Energy and Commerce Committee chairman Frank Pallone (D-NJ) has called for a briefing from HHS secretary Alex Azar on the change, with an explanation of why the department is taking the action now “when the need for accurate tests is so critical.”
Pallone said the HHS announcement “is deeply concerning and suggests that the Trump administration is once again interfering with FDA’s regulation of medical products.”
Pallone said that given the importance of testing in the fight 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….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.’”