The Association for Molecular Pathology (AMP) and world-renowned 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.
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.
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. The FDA rule threatens the ability of professionals in clinical laboratories, 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.
To read the full complaint, please visit https://www.amp.org/AMP/assets/File/advocacy/AMPvFDA_Complaint_8.19.2024.pdf.
