AMP Offers Senate Committee Proposal for Regulation of Laboratory-Developed Tests

With the FDA 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. 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.