CMS And FDA Stand Together Behind FDA Oversight Of LDTs At House Hearing
This article was originally published in The Gray Sheet
CMS Deputy Administrator for Innovation and Quality Patrick Conway and FDA Device Center Director Jeffrey Shuren told a House subcommittee that legislators’ efforts to replace FDA’s proposed laboratory-developed test framework would lead to duplicative, time-consuming, expensive regulation, and could only result in ineffective and delayed diagnostics that might harm patients.
You may also be interested in...
Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.
FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.
Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.