Commissioner Scott Gottlieb is scaling up FDA efforts to assert control over laboratory developed tests, saying in a speech that the agency would take a flexible approach — but first needs the power to act. The FDA last month sent 59 pages of recommendations to lawmakers constructing a bill to regulate LDTs, the custom diagnostic tests that hospitals and clinical labs typically develop for their own use. The FDA has tried to regulate the industry before — with draft guidance in 2014, and with language in the 21st Century Cure Act that was later dropped after labs resisted. “Our device program is constrained by a framework that’s existed since 1976, hasn’t been enforced consistently … and isn’t well-suited to the modern challenges,” Gottlieb told a Friends of Cancer Research forum in the Thursday speech that was titled as a precision medicine discussion but largely tackled diagnostic tests. He said the FDA would follow Congress’ lead on the bill, which is likely to struggle for space on the legislative calendar this year.

https://www.politico.com/newsletters/prescription-pulse/2018/09/17/sena…