A federal court in Texas has invalidated the Food and Drug
Administration’s recent regulation of laboratory developed tests (LDTs), delivering a significant win for clinical laboratories that opposed the measure. The ruling, issued by U.S. District Court Judge Sean Jordan in the Eastern District of Texas, completely vacated the FDA’s final rule and directed the matter back to Health and Human Services Secretary Robert F. Kennedy Jr.
The laboratory industry had strongly contested the FDA’s regulation, contending that it would impede the development of essential diagnostic tests and force laboratories to reduce their testing capabilities, thereby limiting patient access to necessary medical services. Industry representatives have maintained that LDTs are adequately regulated under existing oversight from the Centers for Medicare and Medicaid Services through the Clinical Laboratory Improvement Amendments framework.
Following the court’s decision, the American Clinical Laboratory Association (ACLA), which initiated the legal challenge against the FDA, confirmed that the rule and its associated compliance deadlines are no longer valid. ACLA President Susan Van Meter celebrated the ruling as a triumph for protecting patient access to vital testing services and eliminating burdensome regulations that could have undermined the nation’s clinical laboratory system.
The FDA’s rule had been scheduled to begin implementation on May 6, initially requiring laboratories to comply with medical device reporting requirements, correction and removal procedures, and complaint file maintenance. The regulation would have continued to phase in additional requirements over a four-year period.
In his opinion, Judge Jordan identified two fundamental flaws in the FDA’s approach. First, he determined that the agency’s attempt to expand its jurisdiction under the Federal Food, Drug, and Cosmetic Act of 1938 exceeded its statutory authority, emphasizing that only Congress has the power to modify the law’s text. Second, he rejected the FDA’s broad interpretation of the term “device,” noting that such an expansive definition would inappropriately extend the agency’s oversight to all surgical procedures and physical examinations utilizing medical devices.
The Association for Molecular Pathology, another plaintiff in the case, praised the court’s decisive ruling. The organization’s president, Jane Gibson, emphasized that overturning the FDA rule would prevent billions in additional healthcare costs and preserve access to high-quality care for hundreds of millions of Americans.
The trade association advocated for clarifying existing CLIA regulations as the most effective approach to ensuring the continued development of accurate LDT procedures and proper interpretation of molecular test results.
AdvaMedDx Executive Director Zach Rothstein, while still reviewing the decision, expressed concern about maintaining separate oversight systems for tests serving identical clinical purposes, arguing that this approach neither serves public health interests nor represents efficient resource utilization. He suggested that the court’s decision underscores the need for Congressional action.
The ruling comes after years of unsuccessful attempts by Congress to pass the Verifying Accurate, Leading-edge IVCT Development (VALID) Act. The absence of legislative action to amend the FDCA and clarify the regulatory framework for LDTs had prompted the FDA’s attempt to extend its authority over ensuring the safety and effectiveness of new diagnostic tests.
The decision marks a significant shift in the regulatory landscape for laboratory developed tests and highlights the ongoing debate over appropriate oversight of diagnostic testing in the United States.
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