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- College of American Pathologists Challenges FDA LDT Regulation with Amicus Brief Filing
The College of American Pathologists (CAP) filed an amicus brief on October 7 in a U.S. 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 urges 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. Those costs will significantly burden laboratories, making it unacceptably expensive for them to continue to develop essential and innovative LDTs, resulting in depriving patients of these life-saving tests. The following are some examples:
- Epidermal growth factor receptor (EGFR) tests used to determine whether a patient with non-small cell lung cancer could benefit from targeted tyrosine kinase inhibitor (TKI) therapy
- Immunohistochemical stains used by pathologists in diagnosing and classifying most cancers
“The College of American Pathologists filed this amicus brief because our members fear these regulatory restrictions from the FDA will delay the diagnosis of disease and treatment of patients,” said CAP President Donald Karcher, MD, FCAP. “The CAP had communicated its concerns to the FDA prior to the release of the final rule and urged the agency to take a different tact. However, the FDA moved forward and now pathologists and their laboratories are having conversations about which LDTs will no longer be available to patients in their communities. The FDA’s failure to come to grips with the obvious ramifications on patients of the LDT regulation clearly renders the rulemaking arbitrary and capricious.”
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.
Click here to read frequently asked questions and answers about the CAP's amicus brief.
