AMP celebrates U.S. District Court’s decision to vacate FDA rule on laboratory-developed test procedure regulation
The Association for Molecular Pathology and pathologist Michael Laposata, M.D., Ph.D., announced a favorable ruling in their lawsuit against the U.S. Food and Drug Administration over the regulation of laboratory-developed test procedures.
The ruling by Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas granted AMP’s motion for summary judgment and vacated the FDA rule that would have regulated LDTs as medical devices under the Federal Food, Drug and Cosmetic Act.
AMP President Jane S. Gibson, Ph.D., is a Pegasus-awarded professor of pathology, chair of the Department of Clinical Sciences and director of molecular diagnostics at the University of Central Florida College of Medicine. “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,” said Gibson. “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.”
Eric Konnick, M.D., is AMP’s Professional Relations Committee chair and an associate professor and the associate director of the Genetics and Solid Tumor Laboratory at the University of Washington Department of Laboratory Medicine and Pathology. “The FDA LDT rule would have created an undue burden on laboratories tasked with keeping patients healthy and safe, and would have led to extensive additional requirements in addition to the existing CLIA regulations,” said Konnick. “AMP members continue to work with key stakeholders to develop a more effective and efficient legislative framework that clarifies oversight, enhances transparency, preserves innovation, avoids escalating costs and ensures widespread patient access for these essential medical services.”
To read the full ruling, please visit the AMP website.
