ACLA to FDA on Issuing Draft Guidance to Regulate LDTs: Duplicative Regulation Will Hamper Diagnostic Discoveries, Delay Patient Access to Life Saving Treatments

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) reiterated its concern today regarding the Food and Drug Administration’s (FDA) decision to issue draft guidance for the regulation of laboratory developed tests (LDTs), cautioning that unnecessary and duplicative regulation could delay patient access to life saving treatments and compromise America’s leadership in diagnostic discovery.

“Clinical laboratories have been in the forefront of discoveries that have resulted in better treatments for cancer and infectious diseases, and better tools for managing other serious diseases like HIV,” said Alan Mertz, President of the ACLA. “Diagnostic innovation has thrived under the current regulatory framework and there is great concern in the lab community that additional and duplicative regulation will hamper the ability of researchers and scientists to continue their groundbreaking work.”

Laboratories have been regulated for decades by the Centers for Medicare & Medicaid Services (CMS) under the Clinical Laboratory Improvement Amendments (CLIA) and by state law. LDTs are 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.

“To the extent that stakeholders have concerns about possible regulatory gaps under CLIA, ACLA has long supported enhancing the CLIA regulatory framework, rather than imposing an additional layer of regulation based upon a different statute designed for manufactured products rather than laboratory testing,” Mertz noted in July, referring to the FDA’s assertion that the definition of “medical devices” in the Food, Drug and Cosmetic Act (FDCA) includes LDTs.

In testimony last month before the House Energy and Commerce Subcommittee on Health, Mertz testified, “The flexibility afforded under the CLIA regulatory framework allows laboratories to develop tests quickly and to update them regularly as research and medicine advances, giving patients access to the most current diagnostic testing available. Such flexibility would be lost under the FDA device regulatory framework.”

ACLA will continue to work with Congress, the Administration and other stakeholders to ensure patient access to innovative, safe and reliable clinical laboratory diagnostics.

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