ACLA President Testifies in Opposition to FDA Intent to Regulate LDTs – Questions Statutory Authority, Cautions Against Duplicative Regulation that Could Stifle Innovation and Compromise Patient Access to Critical Diagnostic Tests
WASHINGTON, DC – Testifying before the House Energy and Commerce Subcommittee on Health today, Alan Mertz, President of the American Clinical Laboratory Association (ACLA), expressed concern to lawmakers that additional, duplicative regulation imposed by the Food and Drug Administration (FDA) on laboratory-developed tests (LDTs) would cause a harmful ripple effect throughout the laboratory industry that could hamper diagnostic discoveries and preclude patients from timely access to life saving treatments.
“We are deeply concerned by the FDA’s intent to add another layer of unnecessary regulatory oversight on laboratory-developed tests already subject to strict and thorough regulation,” said Mertz. “Laboratories have been regulated for decades by the Centers for Medicare and Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and by state law. There simply is no need for an additional layer of duplicative regulation that initiates more questions yet provides few answers.”
Mertz’ testimony at the hearing on 21st Century Cures: Examining the Regulation of Laboratory-Developed Tests, noted that LDTs are a vital part of laboratory medicine and the backbone of clinical care in the United States. “The diagnostic information that LDTs yield empowers patients and their doctors with the tools they need to best manage patient care,” testified Mertz. “A large proportion of the clinical laboratory tests performed in this country are performed as LDTs. These are tests developed by physicians, scientists and other highly-trained personnel working in a single laboratory, according to its own processes, to furnish a diagnostic result for use by a clinician.”
Mertz further noted, “America is the world leader in diagnostic medicine, and a reasonable and flexible framework is essential in preserving this vital role. We look forward to continuing to work with Congress, CMS, FDA, and other stakeholders on policies that encourage innovation, ensure safety, and maintain patient access to diagnostic services.”
To view the full text of ACLA’s testimony, please click here.