WASHINGTON, D.C. (2/24/2025) – Following the direction and intent of executive orders signed by President Donald J. Trump, the College of American Pathologists (CAP) is calling on the Department of Health and Human Services (HHS) to terminate the laboratory-developed test (LDT) oversight regulation by the Food and Drug Administration (FDA).
The CAP has opposed the FDA rulemaking and advocated for the administration to rescind the rulemaking by citing significant concerns over extraordinary costs and regulatory burdens on laboratories.
“After the FDA proposed and finalized its rulemaking on the oversight of LDTs, pathologists and their laboratories objected to the arbitrariness and significant costs the new rule imposed on the development of these lifesaving tests,” said CAP President Donald Karcher, MD, FCAP. “Now is the time for the FDA to pull back a regulation that adversely impacts laboratories and their ability to develop and provide these innovative tests for our patients. We urge the administration to act before the first stage of the rulemaking takes effect on May 6.”
President Trump signed the executive order Unleashing Prosperity Through Deregulation on January 31 to eliminate unnecessary regulatory burdens. The FDA LDT oversight rulemaking continues to cause laboratories to reevaluate the LDTs they can offer to patients. The CAP has urged the administration to rescind the rulemaking in a February 14 letter to new HHS Secretary Robert Kennedy and a January 21 communication to President Trump’s transition team.
On February 21, Reps. Brad Finstad (R-MN) and Dan Crenshaw (R-TX) introduced the Freedom for Laboratory Innovation and Testing Act to withhold funding for the FDA to implement the LDT oversight rule. The CAP supports this legislation.
A lawsuit over the LDT regulation is also currently pending in the US District Court of Eastern Texas. The CAP has stood with the plaintiffs in this case seeking to nullify the LDT regulation. The CAP detailed its reasons to vacate the rule in an amicus brief filed in October 2024.
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About the College of American Pathologists (CAP)
As the world’s largest organization of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programs, the College of American Pathologists (CAP) serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. For more information, visit the CAP Newsroom, CAP.org and yourpathologist.org to watch pathologists at work and see the stories of the patients who trust them with their care.