Court Will Hear Oral Arguments in Lawsuit Against FDA Final Rule on LDTs

Oral arguments will be heard on Feb. 19 in the lawsuit concerning federal oversight of laboratory-developed tests (LDTs).

On Jan. 23, the U.S. District Court in Eastern Texas granted a motion for oral arguments to be heard. The plaintiffs -- the American Clinical Laboratory Association and Association for Molecular Pathology -- along with the defendant, the U.S. Food and Drug Administration, submitted a request on Jan. 17 for an oral hearing on their cross-motions for summary judgment.

In the written request, the plaintiffs explained they are seeking an oral hearing “because this case is being decided on dispositive cross-motions and involves important legal issues arising from a major new FDA rule,” while the defendants intend to begin enforcing the rule at issue on May 6, 2025.

The final rule would regulate LDTs as medical devices under the Food, Drug, and Cosmetics Act. The plaintiffs’ lawsuits were consolidated on Sept. 9, 2024, with the shared objective to challenge the statutory validity and ultimately achieve vacatur of the final rule. The FDA filed its closing brief in the case on Dec. 23, reasserting its “unambiguous statutory authority” to regulate LDTs as “diagnostic ‘apparatuses’ or ‘contrivances’ made up of physical components that work together to produce a test result.”

Sources:

https://www.cap.org/advocacy/latest-news-and-practice-data/january-28-2025#story1

https://documents.cap.org/documents/oral-argument-request.pdf

https://www.amp.org/AMP/assets/File/advocacy/DOJ_ClosingBrief_12_23_2024.pdf?pass=71