Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business

The second installment of Ropes & Gray’s new podcast series, Non-binding Guidance, addresses the departure of former FDA Commissioner Scott Gottlieb, who resigned from his position last month. During his time at FDA, Commissioner Gottlieb employed an ambitious policy agenda, taking significant steps to combat the opioid crisis, improve access to generic drugs and biosimilars, confront the use of e-cigarettes by minors, and more. In this episode, Ropes & Gray lawyers Greg Levine, Kellie Combs, and Beth Weinman explore several areas of uncertainty that remain in the wake of Dr. Gottlieb’s resignation: the regulation of laboratory developed tests, dietary supplements, and off-label communications. Tune in to this discussion to learn more about the unfinished business of the Gottlieb administration, the impact of his resignation, and how the agency will move forward under Acting Commissioner Ned Sharpless.