The Association for Molecular Pathology (AMP) has initiated a legal battle against the Food and Drug Administration (FDA) by filing a lawsuit in the U.S. District Court for the Southern District of Texas. The suit challenges a newly finalized rule by the FDA that extends its regulatory oversight over laboratory developed tests (LDTs). AMP, which represents a wide range of professionals including pathologists and laboratory scientists, asserts that the FDA oversteps its legal authority with this rule, which should consequently be invalidated.
AMP’s primary concern is that this increased regulation will significantly disrupt the innovation of new tests and restrict patient access to essential medical services. The association suggests that the enforcement of this rule might lead to the shutdown of many smaller laboratories, potentially elevating healthcare costs significantly. They fear that the repercussions of this rule will be severe enough to warrant urgent court intervention to prevent potential widespread negative impacts on the healthcare system.
The stance taken by AMP is shared by another prominent laboratory group, the American Clinical Laboratory Association (ACLA), which also filed a similar lawsuit shortly after the rule was announced on May 6. Both organizations argue that the jurisdiction to regulate LDTs should remain with the Centers for Medicare and Medicaid Services (CMS), under the Clinical Laboratory Improvement Amendments (CLIA), rather than the FDA. They contend that Congress did not intend for the FDA to regulate these tests as medical devices but rather as laboratory services, which historically falls under the purview of CMS.
Furthermore, AMP’s lawsuit points out that the FDA’s rule seems to infringe upon a clear demarcation in the federal Food, Drug, and Cosmetic Act, which traditionally exempts the agency from interfering in the practice of medicine. AMP and other critics of the rule express concerns that it jeopardizes the ability of clinical laboratories to develop and tailor LDTs according to specific patient needs, particularly in academic, reference, and community health settings across the nation.
The FDA defends the new rule by stating that the complexity and usage of LDTs have grown substantially, leading to elevated risks that necessitate stricter oversight to ensure patient safety. The agency plans to gradually phase out its previous policy of relaxed enforcement over four years, increasing requirements for laboratories to comply with various regulatory standards over this period.
AMP argues that a more effective approach would be to modernize the existing CLIA framework to improve reliability and appropriate application of test results, rather than impose burdensome FDA regulations. They warn that the rule could force laboratories to discontinue providing innovative and critical medical services to vulnerable patients, halt the development of new LDTs essential for addressing fast-evolving diseases like cancers, and diminish preparedness for future public health emergencies.
As the implementation of the FDA’s rule unfolds in stages, it will require laboratories to start adhering to various standards such as medical device reporting and quality system requirements by May 6, 2025. Subsequent stages will introduce compliance with registration, labeling, and investigational use requirements by May 6, 2026, and will finally require premarket review for high-risk diagnostic tests by November 6, 2027.
The lawsuit also includes FDA Commissioner Robert Califf and Health and Human Services Secretary Xavier Becerra as defendants, illustrating the gravity and breadth of the challenge against the FDA’s expanded regulatory approach towards LDTs.
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