Summary: The Association for Molecular Pathology (AMP) and pathologist Michael Laposata have filed a lawsuit challenging the FDA’s new rule that regulates laboratory-developed tests (LDTs) as medical devices, arguing that the FDA lacks the authority to impose such regulations.
Takeaways:
- Legal Challenge: The lawsuit, filed in the U.S. District Court for the Southern District of Texas, contests the FDA’s authority to regulate LDTs as medical devices, which AMP argues could severely disrupt laboratory medicine.
- Significance of LDTs: Laboratory-developed tests have been critical in advancing diagnostics in various medical fields, including rare diseases, oncology, and genetics, often addressing unmet clinical needs with precise and timely testing.
- Proposed Alternative: AMP advocates for modernizing the existing CLIA regulations overseen by CMS, arguing that this approach would better ensure test quality, innovation, and patient access without the drawbacks of the FDA’s rule.
The Association for Molecular Pathology (AMP) and pathologist Michael Laposata, MD, PhD, announced the filing of a lawsuit challenging the recent U.S. Food and Drug Administration (FDA) Rule that regulates laboratory developed test (LDT) procedures as medical devices under the Federal Food, Drug, and Cosmetic Act.
Lawsuit Challenges FDA LDT Rule
The lawsuit was filed in the U.S. District Court for the Southern District of Texas against the FDA; Robert M. Califf, MD, in his official capacity as Commissioner of Food and Drugs; the U.S. Department of Health and Human Services (HHS); and Xavier Becerra, in his official capacity as Secretary of HHS.
“AMP remains very concerned about the wide-sweeping and long-lasting consequences the FDA rule will have for our members and patients across the country,” says Maria Arcila, MD, President of AMP. “We filed this lawsuit to ask the Court to vacate the FDA rule given the agency’s lack of authority to regulate LDTs and to avert the significant and harmful disruption to laboratory medicine. AMP will continue working with key stakeholders to develop a more effective and efficient legislative framework that ensures high-quality patient care while continuing to foster rapid innovation and the promise of new diagnostic technologies.”
Significance of Laboratory-Developed Tests
For decades, LDTs have led to significant clinical advancements and breakthroughs in rare and infectious diseases, human genetics, oncology biomarker testing, and more. Often created in response to unmet clinical needs, they are instrumental for early and precise diagnosis, disease monitoring, and treatment guidance.
These medical procedures are designed, developed, validated, performed, and interpreted by highly trained medical and scientific experts in regulated clinical laboratories. LDTs are not manufactured, packaged, nor commercially distributed as medical devices. Importantly, Congress has not given FDA the authority to regulate LDTs as manufactured products, but instead delegated authority to the Centers for Medicare & Medicaid Services (CMS) to regulate these procedures as laboratory services under the Public Health Service Act.
Potential Impact of the FDA’s LDT Final Rule
The FDA rule threatens the ability of professionals in clinical laboratories, says AMP, including many academic medical centers, reference laboratories, and community health systems across the country, to create, adapt, and modify LDTs to meet patients’ needs, account for supply chain issues, reflect advances in scientific understanding and practice standards, and improve performance characteristics.
AMP has long maintained that the best approach to ensuring the continued development of accurate and reliable LDT procedures and for correct utilization, precise interpretation, and proper application of molecular test results is through modernizing the current Clinical Laboratory Improvement Amendments (CLIA) regulations promulgated by CMS, according to the association. AMP’s legislative proposal to update CLIA builds on the existing oversight framework and provides enhancements where necessary to provide assurances of test quality.
AMP believes this approach is a far more streamlined and cost-effective regulatory framework that improves oversight, enhances transparency, preserves innovation, avoids escalating healthcare costs, and ensures widespread patient access to vital medical services.
