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Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests

 
• By Sue Darcey

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.

Scientist

Sen. Lamar Alexander, D-Tenn., said at a Sept. 20 Health, Education, Labor and Pensions Panel hearing that perhaps Congress should create “an entirely new regulatory agency” to handle regulation of laboratory-developed tests (LDTs), in part because US FDA regulation of the tests would be too slow and expensive.

“Sometimes I think starting from scratch is a good idea,” he told Medtech Insight following the hearing. “Actually starting from scratch … would be preferable to the situation we have...

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