NEW YORK – The US District Court for the Eastern District of Texas ruled on Monday to vacate the US Food and Drug Administration's final rule on laboratory-developed tests (LDTs).
The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical laboratory industry and many segments of the broader healthcare industry, from going into effect. Enforcement of the initial requirements under the rule had been scheduled to begin in May.
The ruling also provides some clarity on what for decades has been the unresolved question of whether the FDA has the legal authority to regulate LDTs. While the agency long insisted it did have this authority and that it had largely declined to exert it due to a policy of "enforcement discretion," most lab industry stakeholders maintained that LDTs fell outside the agency's authority.
In its ruling, the court sided with these stakeholders, writing that the "text, structure, and history" of the Federal Food, Drug, and Cosmetic Act and CLIA "make clear that FDA lacks the authority to regulate" LDTs.
The FDA issued its rule on LDTs on May 6, 2024, following years of agency efforts to assert control of these tests through routes including guidance and support for legislative action. Several weeks later, the American Clinical Laboratory Association (ACLA) and its member organization HealthTrackRx filed a lawsuit against the agency, requesting that the court vacate the rule and enjoin the agency from enforcing it. In August, the Association for Molecular Pathology (AMP) filed its own lawsuit against the FDA over the rule. The two suits were later consolidated into one.
The court said that with its ruling today, it is vacating and setting aside the LDT rule in its entirety and remanding the matter to the US Department of Health and Human Services "for further consideration."
"AMP is extremely pleased with the court’s clear and decisive ruling in our favor, and we hope this will finally end the FDA’s attempts to exert an unwarranted overreach of authority of LDTs," AMP President Jane Gibson said in a statement. "This judgment is a significant victory for our members and for patients across the country. The decision to vacate the FDA rule will avoid adding billions of dollars to healthcare costs and protect access to high-quality care for hundreds of millions of Americans."