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- CAP Challenges FDA LDT Regulation with Amicus Brief Filing
Today, 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 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 these critically important 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 cases ACLA et al. v. FDA, and AMP et al. v. FDA, US District Court Eastern District of Texas.
Read the press release and view a video statement from CAP President Dr. Donald Karcher.