ACLA Oral Statement at FDA Workshop on Regulatory Framework for Laboratory Developed Tests: “FDA Proposed Guidance is Without Statutory Basis and Should be Withdrawn”

BETHESDA, MD – Voicing its strong opposition to the Food and Drug Administration’s (FDA) draft guidance documents outlining that agency’s intent to regulate laboratory developed tests (LDTs), the president of the American Clinical Laboratory Association (ACLA) today unequivocally stated the potentially sweeping new regulatory proposals are “unnecessary, without statutory basis and should be withdrawn.”   ACLA President Alan Mertz delivered the oral statement during the first day of a two-day FDA public workshop on the framework for regulatory oversight of LDTs.

“For decades, LDTs have been comprehensively regulated by CMS, which administers the detailed requirements Congress enacted under the Clinical Laboratory Improvements Act (CLIA), as well as by state regulators,” noted Mertz. “Most labs performing LDTs submit to additional regulatory oversight by ‘deemed authorities’ such as the College of American Pathologists, providing further scrutiny of both operations and the clinical validity of tests.”

The ACLA, along with the American Medical Association, American Hospital Association, and others have requested that the FDA withdraw the guidance documents.

Citing the proposed guidance’s dangerous encroachment upon the practice of medicine, Mertz continued, “Laboratories develop LDTs as part and parcel of the practice of medicine.   They operate in a fundamentally different manner than manufacturers which manufacture products that are distributed in interstate commerce. The FDA’s effort to expand its jurisdiction and treat labs as manufacturers will interfere with the practice of medicine, disrupting the ability of doctors to obtain tests they need to provide the best care to patients.”

Mertz also stated that “by promulgating such sweeping regulatory changes through guidance, the FDA bypasses the requirements of the Administrative Procedure Act.   FDA is avoiding assessing the potentially devastating economic impact of its proposal and avoiding determining whether the benefits it would supposedly provide justify the costs it would undoubtedly impose.”

On October 3, 2014, the FDA published notices in the Federal Register formally announcing their release of the guidance and the beginning of a 120-day public comment period. The comment period ends February 2, 2015.

“ACLA has long supported modernizing the current CLIA framework to keep pace with changing technology,” concluded Mertz. “This could be accomplished without duplicative regulation and cost, and without stifling innovation. We look forward to working with all policymakers and stakeholders on policies that encourage this innovation and maintain patient access to these valuable laboratory services.”

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