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Legislation for LDTs

Scott Gottlieb, the commissioner of the US Food and Drug Administration, says that laboratory-developed tests need some rules, MedCity News reports. Speaking at the AdvaMed conference, Gottlieb said Congress should develop legislation concerning the LDT industry.

"[W]e are at a point where we need some kind of legislation," Gottlieb said, according to MedCity News. "I think there's a better consensus among the various camps around this issue that we could potentially get legislative consensus and I think that the time is right to do that."

He added that the LDTs are no longer a "mom-and-pop industry" where FDA can exercise enforcement discretion, and that the tests are increasingly complex and carry more risk, MedCity News says.

It notes that this means the agency would be moving away from the regulatory approach it described in 2014 for LDTs. The FDA had been leaving LDT regulation to the Centers for Medicare & Medicaid Services under CLIA, but as GenomeWeb reported in 2014, the agency outlined a risk-based approach to bring LDTs under FDA's regulatory eye within a decade or so. FDA, though, delayed finalizing its draft guidance on regulating LDTs in 2016 after the US election.

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