By Stephanie Murg, Managing Director, G2 Intelligence
With the Food and Drug Administration poised to reverse its “enforcement discretion” and begin regulating laboratory-developed tests (LDTs) in the near future, industry groups are on the offensive. On August 4, the Association for Molecular Pathology (AMP; Bethesda, Md.) issued its own proposal for “modernization of CLIA regulations for laboratory-developed testing procedures (LDPs).” Representatives from AMP presented the recommendations to the Senate Health, Education, Labor, and Pensions (HELP) Committee, which is now drafting legislation that would provide opportunities for enhanced support for medical innovation and patient access to new medicines and technologies.
“While we maintain that there is no evidence of systemic problems with laboratory testing or LDPs that would necessitate an increase in what is already rigorous oversight, the CLIA statute and regulations are over twenty years old. Given the advances in technology and laboratory science, these regulations can be modernized to better fit with contemporary practice,” says AMP Professional Relations Chair Roger D. Klein, M.D., J.D. “Our proposal is a streamlined, cost-effective approach that enhances transparency, ensures quality, and preserves innovation.”
The proposal reaffirms AMP’s position that FDA regulations are not appropriate for professional services, calling instead for updates to selected existing CLIA regulations and a tiered, risk-based structure that avoids duplication of activities within and between federal agencies. Low-risk LDTs would be validated by the laboratory, put into service, and subject to inspection in the normal course of laboratory inspection, while for those considered to be of moderate risk, information would have to be submitted for third party review at least 30 days before the LDT is offered to the public: there is a time limit on the review process as well as a grandfathering provision to LDTs in this category.
For those LDTs that fall in the high-risk tier, information would have to be submitted for third party review at least 90 days before the LDT is offered to the public, with a time limit also imposed on this review process. However, AMP’s recommendations don’t shut out FDA entirely: multianalyte assays with algorithmic analyses (MAAAs) with proprietary algorithms must be submitted to FDA unless the laboratory reveals its proprietary algorithm to third party review and inspection, according to the proposal.
For further discussion of the potential regulation of LDTs, see the July issue of G2 Compliance Advisor.