New Wild West on horizon as HHS allows COVID-19 lab-developed tests to bypass FDA
HHS's new policy for COVID-19 lab-developed tests sparks concern of replaying the fallout from unregulated serological assays.
HHS’s decision to exempt laboratory-developed tests for COVID-19 from FDA oversight could repeat the fallout from FDA’s short-lived policy to allow antibody tests on the market without regulatory review.
On Wednesday, 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 new policy overrides provisions that gave FDA authority over LDTs developed in response to a public health emergency. It reignites controversies over the balance between guardrails and speed during a pandemic, and over the regulatory distinction between tests distributed as kits versus those run in centralized labs.
Since the Clinical Laboratory Improvement Amendments (CLIA) of 1988, CMS has overseen the accreditation, inspection and certification process for laboratories; however, the U.S. has not required tests developed and processed within CLIA labs to undergo premarket review by FDA. In contrast, in vitro diagnostics (IVDs) sold as kits that can be processed by any provider are subject to FDA regulation.
The state of emergency declared for the pandemic in January gave FDA oversight over LDTs for COVID-19 via the emergency use authorization (EUA) process, with the logic that inaccurate tests present a greater risk during a public health emergency.
The EUA pathway allows tests to get on the market through a speedier and less intensive process than is typically required for IVDs, while maintaining FDA’s ability to revoke authorization of tests that prove to be of poor quality during postmarket surveillance. Tests with EUA are protected from liability under the Public Readiness and Emergency Preparedness Act (PREP Act).
With Wednesday’s announcement, FDA loses the authority to determine what LDTs can come on the market, and to remove poorly performing LDTs from the market. LDTs that come on the market without EUA are not eligible for PREP Act coverage from liability; those with an active EUA are unaffected by the announcement.
The decision has sparked concern that inaccurate tests will flood the market, the same issue that arose following FDA’s March decision to exempt serological tests for COVID-19 antibodies from regulatory review. The agency changed its policy in May, requiring serological test developers to seek EUA and removing tests that failed to meet performance standards from the market (see “FDA Tightens Reigns on COVID-19 Antibody Tests”).
“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,” said Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-N.J.) in a statement. He called for a briefing on the change from HHS Secretary Alex Azar.
In response to criticisms, HHS General Counsel Robert Charrow said, “it is false to say that this will lead to unregulated, low-quality COVID-19 tests. Every single COVID-19 test in the United States will still be regulated at the federal level. This simply removes an additional regulatory barrier that was erected in January that at most other times is not required.”
In its announcement, HHS said the decision was consistent with President Donald Trump’s executive orders on reducing regulation and controlling regulatory costs, and regulatory relief to support economic recovery. The statement said the de-regulatory action was part of the Trump Administration’s commitment “to ensuring that the American people are protected against future pandemics, and to keeping duplicative regulations and unnecessary policies from interfering with those efforts”
Congress has been moving to erase the distinction between LDTs and IVDs through the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which creates a single risk-based regulatory framework for both types of tests. The bill was drafted in 2018 and reintroduced in March, but will likely have to wait until the next PDUFA reauthorization in 2022 to become law (see “Diagnostic Regulation Revamp”).