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FDA Workshop Continues the Debate About LDT Regulation

By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence The debate regarding FDA regulation of laboratory developed tests (LDTs) continues to swirl as the FDA held a two-day workshop providing a forum for public comment from more than 80 presenters. The conversation outside the forum was robust as well with two JAMA editorials, one for and one against regulation, published on the heels of the American Clinical Laboratory Association’s issuance of a white paper challenging the FDA’s authority to regulate LDTs via its guidance document (See National Intelligence Report, 1/8/15, p. 1). JAMA published two opposing Viewpoints just prior to the FDA workshops, highlighting arguments for and against FDA regulation. The Viewpoint supporting regulation noted the “profound changes in the nature of these products” since the 1970s and the advent of device regulation, changes in technology and resulting “new concerns for patients.” The opposition cited the risk of laboratory closures, limited patient choice and hampered innovation. It criticized a lack of evidence of “any consistent or systemic harm” from LDTs and suggested that an alternate solution might be “an expansion of oversight standards in CLIA to more robustly address genomic testing.” The FDA workshop organized public comment and panel discussions […]

By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence

The debate regarding FDA regulation of laboratory developed tests (LDTs) continues to swirl as the FDA held a two-day workshop providing a forum for public comment from more than 80 presenters. The conversation outside the forum was robust as well with two JAMA editorials, one for and one against regulation, published on the heels of the American Clinical Laboratory Association’s issuance of a white paper challenging the FDA’s authority to regulate LDTs via its guidance document (See National Intelligence Report, 1/8/15, p. 1).

JAMA published two opposing Viewpoints just prior to the FDA workshops, highlighting arguments for and against FDA regulation. The Viewpoint supporting regulation noted the “profound changes in the nature of these products” since the 1970s and the advent of device regulation, changes in technology and resulting “new concerns for patients.” The opposition cited the risk of laboratory closures, limited patient choice and hampered innovation. It criticized a lack of evidence of “any consistent or systemic harm” from LDTs and suggested that an alternate solution might be “an expansion of oversight standards in CLIA to more robustly address genomic testing.”

The FDA workshop organized public comment and panel discussions around six topics focusing on components and labeling, clinical validity and intended use, test categories for continued enforcement discretion, adverse event reporting, classification, and quality system regulation. Presenters included representatives of various laboratories including reference, molecular pathology and public health laboratories; laboratory associations including the American Clinical Laboratory Association, the Association for Molecular Pathology and College of American Pathologists as well as non-laboratory specific organizations such as the American Medical Association, American Heart Association, National Library of Medicine, and organizations representing diseases and illnesses uniquely affected by LDTs such as Lyme disease, infectious disease, transplantation and cancer. The medical device manufacturing industry and academic institutions also weighed in on the issues.

There was some consensus among the presenters concerning the desire to ensure quality patient care but divisions arose with regard to how FDA regulation would positively or negatively affect patient care. Proponents cited the need for regulation to ensure patient safety and avoid disincentives for manufacturers who undertake the cost of FDA approval processes for their test kits only to compete with LDTs that weren’t subject to that process. Opponents noted the proposal’s potential adverse impact on availability of rare tests or tests for rare diseases that wouldn’t be profitable if subjected to costly approval processes, the potential threat to innovation and financial impact on laboratories providing significant numbers of LDTs.

For more detailed analysis of the public debate surrounding proposed LDT regulation, see the next issue of National Intelligence Report.