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- LDT Lawsuits Against FDA Consolidated in US District Court
Lawsuits over the federal oversight of laboratory-developed tests (LDTs) filed by the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) will be consolidated by the courts, according to a motion filed in the US District Court Eastern District of Texas on September 9. As the two entities challenge and seek to stop the Food and Drug Administration’s (FDA’s) regulation on the oversight of LDTs, the FDA proposed combining the cases, and ACLA and AMP agreed to consolidate.
The groups similarly argue the FDA’s LDT oversight final rule exceeded the agency’s authority and violated the Administrative Procedure Act, which establishes the federal rulemaking process for federal agencies to follow.
The CAP has also opposed the FDA regulation and is drafting an amicus brief that urges the court to also vacate the FDA regulation. The CAP believes the FDA acted arbitrarily and capriciously in violation of the Administrative Procedure Act. The CAP will provide additional updates on this issue as new information emerges.
Under a timeline in the September 9 motion, amicus briefs in support of the plaintiffs will be due by October 7. ACLA’s and AMP’s closing briefs would be due by November 25 and the FDA’s closing brief would be due by December 23. A final decision may not be made until Summer 2025.
Learn more about the CAP’s laboratory-developed test oversight advocacy.