Lexology: Lawmakers To Introduce Diagnostic Test Regulation Bill
Bipartisan legislation to comprehensively address regulation of diagnostic tests will likely be introduced in the House and Senate this month.
Reps. Diana DeGette, D-Colo., and Larry Bucshon, R-Ind., and Sens. Richard Burr, R-N.C., and Michael Bennet, D-Colo., will introduce the bills, which would build on a discussion draft circulated in late 2018.
The issue has for years been a subject of intense debate among clinical labs, diagnostic test manufacturers, and the Food and Drug Administration (FDA). Current law gives the Centers for Medicare and Medicaid Services some authority over lab-developed tests, while FDA regulates diagnostic tests as medical devices. The overhaul would create a new category called “in vitro clinical tests” that would capture both diagnostic tests and lab-developed tests and provide a regulatory framework through the FDA – a move then-Commissioner Scott Gottlieb called for in 2018.
The legislative sponsors have gathered input from stakeholders since the introduction of the discussion draft in late 2018, and also needed to bring Burr onboard to replace retired Sen. Orrin Hatch, R-Utah, the former chairman of the Senate Finance Committee.
Indeed, the Trump administration is now facing increasing scrutiny over the botched rollout and possible contamination of coronavirus test kits from the Centers for Disease Control and Prevention.