ACLA Praises Letter to OMB From Nation’s Leading Academic Medical Center Labs Opposing FDA Regulation of Laboratory Developed Tests

WASHINGTON, DC – The American Clinical Laboratory Association (ACLA) today lauded a letter sent from twenty three laboratory directors of the nation’s most prestigious academic medical centers to Brian Deese, Acting Director of the Office of Management and Budget (OMB), urging him to refrain from releasing draft guidance from the Food and Drug and Administration (FDA) that would impose an additional cumbersome regulatory approval process on laboratory developed tests (LDTs). The OMB Office of Information and Regulatory Affairs (OIRA) is charged with conducting reviews of regulatory policies. “Clinical laboratories within the nation’s most esteemed academic medical centers have voiced unified opposition to FDA guidance overseeing LDTs. FDA intervention would add another layer of unnecessary and duplicative regulation to the LDT approval process, impose a stranglehold on diagnostic innovation and reduce patient access to the latest groundbreaking diagnostic advancements,” said Alan Mertz, President of ACLA. “This letter represents a strong signal to the OMB and the FDA that an illustrious non-profit lab community with worldwide credibility objects to subjecting LDTs to the FDA regulatory process.” Currently, LDTs are regulated under a three part framework consisting of federal regulations under the Clinical Laboratory Improvement Amendments (CLIA), state laws, and accreditation by deemed authorities such as the College of American Pathologists. The FDA proposal would assign regulation of LDTs as medical devices under the Food, Drug, and Cosmetic Act (FDCA). “The letter from the academic laboratory community states that diagnostic lab services are just that – services – and not medical devices,” said Mertz. “The letter also rightly points out that most scientific diagnostic discoveries have emerged from the laboratory research environment and have opened the door for health agencies to control worldwide disease crises..” Signers of the letter to OMB are licensed, board-certified physicians and non-physician doctoral level laboratory directors practicing academic anatomic and clinical pathology. Their letter characterizes their mission as one that is in the best interest of the patient, patient care, the public health and health care innovation. “It is our hope that the OMB will refrain from releasing the FDA guidance and respect the efficiency, depth of oversight and strict review process already in place that is allowing our nation’s academic medical centers to provide safe and effective state of the art research and testing,” said Mertz.

Print page / Save as PDF