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- Video Statement: Dr. Karcher Discusses Amicus Brief to Vacate LDT Regulation
On October 7, the CAP filed an amicus brief in a US District Court against the Food and Drug Administration (FDA) and its regulation of laboratory-developed tests (LDTs). The CAP joined the American Clinical Laboratory Association (ACLA) and the Association for Molecular Pathology (AMP) in challenging the LDT rulemaking by the FDA, which acted arbitrarily and capriciously in violation of the Administrative Procedure Act.
In the amicus brief, the CAP urged the court to vacate the FDA regulation for several reasons, including the ultimate impact on patient access to diagnostic tests and the agency failing to adequately justify the rule’s unsustainable costs that will hinder the development of LDTs.
When the court issues its ruling, the CAP further urges the court to avoid suggestions that LDTs constitute the practice of medicine. The CAP has emphasized that the states, not the federal government, are primarily responsible for regulating medical practice.
Read the CAP’s amicus brief to the court case ACLA and HealthTrackRX, Inc. v. FDA, US District Court Eastern District of Texas and watch the video statement released by CAP President Donald Karcher, MD, FCAP here.