The College of American Pathologists (CAP) filed an amicus brief in the U.S. District Court on Oct. 7, challenging the U.S. Food and Drug Administration regulation of laboratory-developed tests (LDTs).
The CAP now joins the American Clinical Laboratory Association and the Association for Molecular Pathology in legally challenging the LDT rulemaking, which the plaintiffs argue violates the Administrative Procedure Act.
“The CAP’s amicus brief agrees that the court should vacate the regulation because the FDA acted arbitrarily and capriciously in violation of federal rulemaking statute,” CAP President Donald Karcher, M.D., said in a video statement.
The introduction to the amicus brief states that the FDA attempted “to downplay the Final Rule’s impact through a dizzying labyrinth of exceptions currently set forth in the rule’s preamble” and will come to incur high compliance costs on clinical laboratories’ use and development of LDTs.
The CAP urges the court to limit its ruling simply to vacating the FDA action. In the instance that the court addresses broader questions of FDA statutory authority, the CAP advises it to “avoid ruling in a way that could have unintended consequences for LDT regulation going forward.” For example, the court should be careful not to imply that LDTs constitute “the practice of medicine,” as states, rather than the federal government, are responsible for regulating medical practice.
Additionally, the CAP states that the court should not imply that the existing Clinical Laboratory Improvement Amendments (CLIA) framework renders additional FDA involvement to be unnecessary. The CAP does not endorse CLIA expansion as an alternative to the final rule, but instead advocates for a framework in which both the FDA (with its expertise authorizing highly complex tests) and the Centers for Medicare & Medicaid Services (with its expertise overseeing laboratory operations more generally) play a role in test regulation.
Sources:
https://www.cap.org/advocacy/latest-news-and-practice-data/october-7-2024
https://documents.cap.org/documents/cap-amicus-brief-20241007.pdf
https://players.brightcove.net/6092019297001/xAHQ3X1Ot_default/index.html?videoId=6362954834112
