Leading medical center labs oppose FDA regulation of laboratory developed tests

July 21, 2014

Twenty-three laboratory directors from prestigious academic medical centers recently sent a letter to Brian Deese, Acting Director of the Office of Management and Budget (OMB), urging him to refrain from releasing draft guidance from the Food and Drug Administration (FDA) that would impose an additional cumbersome regulatory approval process on laboratory developed tests (LDTs).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.

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.

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 says their mission is in the best interest of patients, patient care, the public health, and healthcare innovation.

Among laboratory advocates applauding the letter are the American Clinical Laboratory Association and ARUP Laboratories. “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,” says 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.”

“Neither I nor my colleagues running nonprofit clinical laboratories in academic medical centers can stress enough the crippling domino effect the FDA approval process would have on diagnostic laboratory innovation within the laboratory environment,” says Edward R. Ashwood, MD, president and CEO of ARUP Laboratories. “Current regulations allow flourishing laboratory research environments to facilitate sophisticated scientific discoveries. We support the current regulatory structure for LDTs.” Read the letter.

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