A Texas judge has ruled against the US Food and Drug Administration (FDA) in a court case that challenged the agency’s plans to regulate laboratory-developed tests (LDTs) – defined as in vitro diagnostics (IVD) products – as medical devices under the Federal Food, Drug, and Cosmetic Act (FDCA).
Filed by the American Clinical Laboratory Association (ACLA), member company HealthTrackRx, and the Association for Molecular Pathology (AMP) at the US District Court for the Eastern District of Texas in 2024, the lawsuit asserted that the use of the medical device framework as mooted in the FDA’s Final Rule was “inappropriate and ill-suited” for regulating LDTs.
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Consequently, the plaintiffs’ lawsuit expressed that the FDA’s Final Rule must be vacated under the Administrative Procedure Act (APA) due to it being “in excess of [the FDA’s] statutory jurisdiction, authority, or limitations” and amounted to an “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law”.
US district judge Sean Jordan agreed. Ruling in favour of the laboratory representatives, Jordan set aside the case “in its entirety”, remanding the matter to the secretary of Health and Human Services (HHS), RFK Jr, for further consideration.
In the case’s accompanying memorandum, Jordan noted that existing Clinical Laboratory Improvement Amendments (CLIA) under which LDTs have long been regulated, were already sufficient and that the “text, structure, and history” of the FDCA and CLIA make clear that the “FDA lacks the authority” to regulate laboratory-developed test services.
Upon the Final Rule’s release last year, the FDA’s plans for LDTs were met with opprobrium from across the healthcare sector.
The American Hospital Association (AHA) expressed concerns that regulating LDTs under the FDA’s medical device framework could result in patients losing access to “many critical tests and stifle innovative advances” in hospital and health system laboratory medicine.
In paediatric care, discontent was expressed over how the rule may affect the access to many tests required for children. “[Tests] with rare, uncommon, and often life-threatening, diseases will no longer be available with significant negative implications for their overall health and wellbeing,” the Children’s Hospital Association wrote in a letter to the FDA.
Commenting on the court ruling, ACLA president Susan Van Meter said: “The court’s ruling ensures that clinical laboratories can continue to focus on their primary mission – offering innovative and reliable diagnostics that save and improve the lives of millions of patients every day.
“This is a victory that protects patient access to critically needed testing services and removes burdensome regulations that would have undermined the clinical laboratory system in this country.”
The outcome of the court case is likely to be a significant relief to those in the diagnostic industry, with some in the space “bracing for uncertainty”, according to GlobalData analysts who observed that the discord and uncertainty sown by the FDA’s Final Rule had left the diagnostics industry at a ‘practical standstill’.
