The Trump administration’s new Food and Drug Administration (FDA) commissioner, Scott Gottlieb, MD, inherits an uncertain path for the agency around laboratory-developed tests (LDT). FDA halted the release of its final guidance regulating LDTs 10 days after the November 8 election. However, some of Gottlieb’s own words about LDTs may offer clues to his approach. In fact, Gottlieb has a long track record of public comments on FDA regulation of LDTs, writing in the Wall Street Journal, USA Today, and other publications.
In most cases, Gottlieb supported a more limited regulatory approach for FDA on LDTs, warning that regulation could stifle innovation and harm the public with higher costs. For example, writing for Forbes in 2016, Gottlieb commented that, “When the proper function of a novel technology is also tied closely to how it’s being used, it argues for a much more comprehensive approach to oversight. It is one more reason why the regulation of lab tests is best left to a more robust CLIA, and not FDA.”
In that article, he defended the distinct roles played by the Centers for Medicare and Medicaid Services (CMS) in regulating lab services and by FDA in regulating devices. “If you’re a hammer—and an agency accustomed to bucketing its regulatory units based on the hardware—then the whole world looks like a collection of nails, or in this case, diagnostic
devices,” he wrote of FDA.
Before his most recent work at the conservative think tank American Enterprise Institute, Gottlieb served during the George W. Bush administration as FDA deputy commissioner for medical and scientific affairs and then as an adviser to the Centers for Medicare and Medicaid Services when the agency launched its prescription drug benefit program