Federal Judge Vacates FDA’s LDT Rule

ASCP celebrates huge advocacy victory for patients, labs, and our community

U.S. District Court Judge Sean D. Jordon has ruled that the U.S. Food and Drug Administration (FDA) lacks the statutory authority to regulate laboratory developed tests (LDTs), finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others.  ASCP submitted an amicus brief supporting the plaintiffs.  The court stated that the "proper remedy is vacatur of the final rule" and remanded the case to the FDA for further consideration in light of the opinion.

The court held that the statutory language unambiguously confirms that a "device" is a tangible, manufactured product, not a professional service. Accordingly, the FDA "may regulate manufacturers of only commercially distributed medical 'devices.'" In contrast, said the court, "laboratory services are professional medical services that are qualitatively and categorically different from the tangible goods that FDA may regulate as 'devices.'"

The court further held that the broader context of the statutory scheme as whole, and the history of the Federal Food, Drug, and Cosmetic Act (FDCA) and the Clinical Laboratories Improvement Act (CLIA), support the court's conclusion.  The court stated it would be "peculiar" to conclude that the FDCA reaches into a professional field — clinical laboratory-developed test services — for which Congress has established a separate, comprehensive, specialized regulatory framework - CLIA.  "Congress has already considered the distinct issues raised by laboratory-developed test services in CLIA" and "chose to address those issues by vesting regulatory authority in CMS, not in FDA. Through the final rule, it appears that FDA is attempting to circumvent that legislative decision.  It has no authority to do so." 

ASCP, which is opposed to the excessive bureaucratic and monetary requirements, delays, and burdens that are inherent in FDA’s oversight scheme, is extremely pleased with Judge Jordon’s decision.  ASCP President Gregory Sossaman, MD, MASCP said, “this is a clear victory for quality patient care.  Under FDA’s oversight plan, it would be virtually impossible for most laboratories to continue providing these critical services, and patients would suffer from a lack of access to these services."

Judge Jordon’s order to vacate the rule means that the Final Rule issued by FDA is no longer legally binding.  As a result, clinical laboratories with LDTs are not required to comply with FDA’s implementation requirements for LDT oversight.  It is unclear whether the Trump Administration will seek to appeal the ruling.  However, ASCP has urged the Trump Administration to rescind the rule and will urge the Administration not to appeal the ruling.