LDT Rule Override Takes Center Stage as ACLA, Congress Seek to Undo Rule

ASCP Holds Town Hall on LDTs Rule

The U.S. Food and Drug Administration’s Final Rule on Laboratory Developed Tests (LDTs) continues to raise concerns within the laboratory community, as the American Clinical Laboratory Association (ACLA) just filed a lawsuit challenging the FDA’s authority to regulate LDTs. In addition, Congress is considering a resolution that would override the FDA regulation. ASCP, which opposes the FDA’s rule, is supporting both efforts to override the FDA rule.

ACLA’s lawsuit argues that the FDA lacks the statutory authority to regulate LDTs. ACLA, along with ACLA member laboratory HealthTrackRx, is asking the court for a declaratory judgement that the FDA is not authorized to regulate laboratory testing under the Federal Food, Drug and Cosmetic Act. ACLA’s suit maintains that LDTs are professional services, not manufactured medical devices, and that Congress has never granted the FDA authority to regulate these services. Congress delegated 

authority to the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Amendments (CLIA) to regulate such services, ACLA maintains.

Not to be outdone, Congress is also considering the issue of overriding the FDA’s Final Rule on LDTs. Several members of Congress, including Representatives Brad Finstad (R-MN) and Dan Crenshaw (R-TX) and Senator Rand Paul (R-KY), have introduced Congressional Review Act resolutions to repeal FDA’s final rule.

ASCP Town Hall on LDTs

To help ASCP members and the broader laboratory community better understand the rule, ASCP recently hosted a Town Hall. The session, which included members of ASCP’s LDT Task Force as faculty for the session, provided an overview of FDA’s plans for LDT oversight. The ASCP Town Hall was moderated by Chris Tormey, MD, MASCP, with expert panelists Jonathan R. Genzen, MD, PhD, FASCP; William Finn, MD, MASCP; and Michelle Campbell, MS, MLS, (ASCP)^CMMB^CM, SC^CM on May 21. More than 2,000 individuals registered for the webinar. ASCP will continue to diligently monitor developments as they occur.

The FDA requirements for LDTs are extensive, and laboratories planning to continue offering LDTs once the FDA rule goes into effect on May 6, 2025, should familiarize themselves with the FDA’s requirements as soon as possible. For those who did not get a chance to see the ASCP LDT Town Hall, a recording of the session is available here.

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