The Association for Molecular Pathology (AMP), along with University of Texas pathologist Michael Laposata, has initiated a lawsuit against the Food and Drug Administration (FDA). This legal action is a response to the FDA’s decision to regulate lab-developed tests (LDTs), which the AMP argues exceeds the agency’s regulatory authority. This suit, filed in Texas, marks the second challenge against the FDA’s rule, following a similar lawsuit by the American Clinical Laboratory Association in May.
The core issue at stake is the FDA’s role in the oversight of LDTs, which are tests developed and performed within individual laboratories. These tests have historically operated under a framework of regulation distinct from that of commercially distributed diagnostic tests. The FDA argues that more comprehensive oversight is necessary to ensure the safety and efficacy of LDTs, given their critical role in patient care and diagnosis.
AMP president Maria Arcila has articulated that the lawsuit aims to compel the court to invalidate the FDA’s rule on the grounds of exceeding its regulatory jurisdiction. According to Arcila, the enforcement of this rule could lead to significant disruptions within the field of laboratory medicine, potentially affecting the delivery of health care services reliant on these tests.
This legal battle underscores a broader debate over the appropriate scope of regulatory oversight in health care, balancing between ensuring patient safety and fostering innovation in medical testing. The outcome of this lawsuit could have significant implications for the regulation of laboratory-developed tests moving forward.
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