Scott Gottlieb, FDA Commissioner, is resigning

Gottlieb, one of the best-regarded appointments in President Trump’s administration, will be leaving the agency in a month, according to numerous press reports. The nominal reason is to spend more time with his family, which is often Washington-speak for disenchantment with one’s role. The Washington Post reported that White House sources said Gottlieb “could even be invited back” in some other capacity.

In two years in office, Gottlieb racked up an impressive list of accomplishments: nearly 1,000 generic drug approvals and 46 new drug approvals in 2018; significant actions on genetic therapies (besides approving the first three in 2017); and expanding adverse-event reporting. Non-pharma activities were also significant, especially in efforts to regulate tobacco and nicotine products more rigorously. FDA’s budget—budgeting being a hotly contested part of Washington bureaucracy—was up around 8% for FY 2019, on par with defense spending increases and roughly double what the rest of HHS is seeing.

Gottlieb was also quite vocal about a topic near and dear to readers of Pharmaceutical Commerce: the implementation of the Drug Supply Chain and Security Act, now just past the midpoint of its 10-year rollout.

The resignation comes just as Congress is cranking up a raft of new measures to address drug policy and the cost of drugs specifically, with efforts ranging from enabling drug importation to changing patent-exclusivity policies. Gottlieb’s voice will be missed as these efforts progress.