January 28, 2008
The American Clinical Laboratory Association has proposed, in comments to the Food & Drug Administration, a regulatory model addressing the continuing controversy over the FDA’s decision to require premarket review for In Vitro Diagnostic Multivariate Index Assays (IVDMIAs). NIR recently talked with David Mongillo, ACLA’s vice president for policy and medical affairs, about the significance of the proposed model.
The FDA, in draft guidance to the lab industry, describes IVDMIAs as gene- or protein-based tests that combine assays and algorithms to produce results tailored to a specific patient. Examples include tests for breast and prostate cancer, cardiovascular disease, and Alzheimer’s. What makes IVDMIAs different, the FDA contends, is that the algorithms are proprietary, making it difficult for physicians to interpret results and validate them independently. Lab and pathology groups have challenged what they regard as FDA overreach, saying it will stifle innovation and impede patient access to new and valuable tests. The HHS Secretary’s Advisory Committee on Genetics, Health & Safety (SACGHS) has also registered its concern, urging the FDA to take a go-slow, broad-based consultative approach to the issue.
At the heart of ACLA’s model, Mongillo noted, is a Memo of Understanding (MOU) between the FDA and the Centers for Medicare & Medicaid Services that runs the CLIA lab regulatory program. The MOU would maintain CMS/CLIA as the exclusive regulatory authority for lab test services, while defining a major consultative role for the FDA on the clinical validity of specific IVDMIAs and their promotional claims. The MOU also would define an IVDMIA risk prioritization scheme and validation criteria for those deemed high risk.
No single agency has the infrastructure to handle the exploding field of genetic and genomic testing, Mongillo told NIR, and without interagency coordination, clinical labs are subject to duplicative and redundant oversight by both CMS and the FDA, something neither Congress nor the agencies intended. The MOU would clearly sort out and formalize the respective oversight responsibilities of these agencies, Mongillo said. Use of an interagency MOU for this kind of clarification is not unprecedented, he noted, citing the area of CLIA waived test categorization as one example.
For ACLA, as for SACGHS, the development of a risk-based IVDMIA regulatory framework built on industry consensus is crucial. The FDA made its own decision, Mongillo said, that certain IVDMIAs present increased risk, justifying tighter oversight. But on closer examination, ACLA found some well established tests do not merit this ranking, for example, estimated glomerular filtration rate to assess renal function and newborn screening for neural tube defects. In revising its guidance, the FDA agreed, saying it did not intend for all IVDMIAs to fall under premarket review. But this amounts to guidance by exclusion, Mongillo said, and that is not the way to go. "The FDA [focuses on] risk by technology platform," he added. "Why not also look at a test’s intended use, as an adjunct to medical decision making, as part of a process of clinical decision points?"
Mongillo pointed out that the ACLA model envisions premarket review for IVDMIAs deemed high risk, but this would be done as part of CLIA enhancements to check clinical validity and promotional claims. All other IVDMIAs would have post-market review by CMS during CLIA inspections or as required by a CMS-FDA MOU.
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January 28, 2008 - Table of Contents
