The American Clinical Laboratory Association is arguing in a new lawsuit that the FDA has overstepped its authority by bringing laboratory-developed tests (LDTs) under its purview, the first major legal challenge to the new regulation.
In a 450-page lawsuit filed Wednesday in the US District Court for the Eastern District of Texas, the ACLA argued that such a change in regulation should have come from Congress, not the FDA. The ACLA was joined in the lawsuit by HealthTrackRx, an infectious disease diagnostic company based in Denton, Texas.
Last month, the FDA published its final rule outlining how it will regulate LDTs as medical devices. Until now, the tests have been regulated mainly by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments law, better known as CLIA. Under CLIA, labs certified by CMS have been allowed to develop and run their own tests, typically without having to put them through an FDA process.
In the lawsuit, the ACLA argued that CLIA already established the legal framework for how CMS, the FDA and the CDC assess labs and tests, and that the FDA didn’t have the ability to claim authority to review LDTs as medical devices. The group is also arguing that LDTs are classified as professional services, not medical devices, and shouldn’t be regulated as such.
ACLA also claims that the FDA hasn’t shown clear evidence to support the need for the final rule, saying that it largely focuses on anecdotal evidence and media stories.
For years, Congress has floated legislation called the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which would create a risk-based regulatory framework for LDTs and create a user fee program for in vitro diagnostics, but the bill hasn’t seen much movement since it nearly crossed the finish line in 2022.
“Congress has also repeatedly considered but has chosen not to enact legislation that would have granted FDA authority to regulate the essential diagnostic services that laboratories provide,” ACLA President Susan Van Meter said on a press call Wednesday. “It is unclear why Congress would consider new legislation to grant FDA authority that the agency claims it already granted decades ago.”
The FDA declined to comment.