Lab Trade Group Urges Court to Vacate FDA Test Regulation

The FDA can’t justify its regulation classifying laboratory-developed tests as medical devices because Congress never granted them that authority, a leading lab industry group told a federal court.

The Food and Drug Administration’s new regulation over laboratory-developed tests (LDTs) is arbitrary and capricious and in violation of the Administrative Procedure Act, the American Clinical Laboratory Association and HealthTrackRx wrote Tuesday in a motion for summary judgment in the US District Court for the Eastern District of Texas.

The motion comes after ACLA in May filed a lawsuit against the agency’s May 6 final rule, which seeks to regulate LDTs as medical devices under the Federal Food, Drug, and Cosmetic Act.

The plaintiffs wrote the FDA “faces a heavy burden to justify its extraordinary position,” because “Congress has never granted FDA authority to regulate professional laboratory services as manufactured medical devices,” and “the agency’s attempts to mitigate the effects of its sweeping power grab only confirm that its position is untenable.”

“FDA’s new rule is no run-of-the-mill regulation,” the ACLA wrote.

The plaintiffs for the first time in the case use a recent US Supreme Court June ruling that rolled back agency deference to support their lawsuit. The high court in Loper Bright Enters. v. Raimondo overturned the Chevron doctrine, which previously allowed courts to accept a federal agency’s reasonable interpretation of ambiguous statutes.

“Under fundamental principles of statutory interpretation and administrative law, courts must interpret the FDCA using their ‘independent judgment,’ without deference to FDA’s views,” the ACLA wrote, pointing to Loper Bright.

The court must also “exercise independent judgment” and “’use every tool at their disposal to determine the best reading of the statute,’ without deference to the agency’s views,” the ACLA added.

Plaintiffs say they have standing to challenge the FDA’s final rule because ACLA’s members include laboratory services providers such as HealthTrackRx, Quest Diagnostics, Labcorp, Mayo Clinic Laboratories, and ARUP Laboratories.

ACLA also has associational standing “because at least one of its members has standing, this case is germane to ACLA’s organizational mission, and ACLA seeks only ‘prospective or injunctive relief,’ which does not require individualized proof.”

A pending lawsuit filed by a group representing molecular pathologists is also seeking to block the FDA’s authority to regulate LDTs.

King & Spalding LLP and Covington & Burling LLP represent the ACLA.

The case is Am. Clinical Lab. Ass’n v. FDA, E.D. Tex., No. 4:24-cv-479, motion for summary judgment filed 9/3/24.