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ACLA Sues FDA Over Laboratory-Developed Test Final Rule


NEW YORK – The American Clinical Laboratory Association (ACLA) and its member company HealthTrackRx said Wednesday that they have filed a lawsuit against the US Food and Drug Administration challenging the agency's May 6 final rule on laboratory-developed tests (LDTs).

With the suit, which was filed in the US District Court for the Eastern District of Texas, ACLA aims to establish that the recently published final rule giving the FDA oversight of LDTs exceeds the agency's legal authority. It has requested that the court enter a declaratory judgment that the FDA cannot legally regulate LDTs under the Federal Food, Drug, and Cosmetic Act (FDCA) and enter an order vacating the final rule and enjoining the agency from enforcing it.

The FDA has maintained for more than three decades that is has the authority to regulate LDTs under the FDCA. It has historically declined to exercise this supposed authority, instead adopting what it has called a policy of enforcement discretion.

More recently, however, the agency argued that its policy of enforcement discretion was no longer appropriate given the increasing complexity of LDTs and their ubiquity throughout the healthcare system, including for the diagnoses and management of life-threatening conditions. It also noted that a number of vendors had begun offering their tests as LDTs as a way of avoiding FDA regulation, even though these tests were marketed to large and diverse customer bases much like traditional IVDs.

Following the collapse in 2022 of Congress' effort to pass legislation giving the agency explicit oversight of LDTs, the agency began its own efforts to regulate these tests through the rulemaking process. This effort was opposed by much of the clinical lab industry, which has raised concerns that FDA oversight will hamper lab innovation and flexibility, limiting test development and, ultimately, harming patient care. When the FDA published its final rule on LDTs in May, a legal challenge to the rule was widely expected.

During a press call to discuss the lawsuit, ACLA President Susan Van Meter and ACLA Chair and CEO of Mayo Clinic Laboratories William Morice detailed the organization's problems with the final rule. They focused largely on the lab industry's longstanding concerns that FDA oversight will impair access to testing and hurt patients and its belief that the FDA lacks legal authority for the move.

Van Meter also highlighted specific provisions in the final rule, raising in particular the large number of carve-outs, which she said both called into question the need for FDA oversight while creating "enormous regulatory uncertainty."

"Indeed, the fact that the FDA found it necessary to establish a complex regulatory system with multiple carve-outs only serves to emphasize that the [medical] device regime is a terrible fit for laboratory testing services," she said.

Van Meter added that ACLA continues to advocate for a legislative approach to LDT regulation, noting that the organization remains "committed to working with Congress, FDA, and other stakeholders to advance appropriate legislation."