US Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month, a sudden resignation that calls into question how the agency will handle issues such as surging e-cigarette use among teens and efforts to increase competition in prescription drugs. Gottlieb has been commuting weekly to Washington from his home in CT and is leaving to spend more time with his family, the official said.
"This has been a wonderful journey and parting is very hard", he said in a tweet of his own, adding that he was "immensely grateful for the opportunity to help lead this wonderful agency". "He and his talents will be greatly missed". On Twitter, the American Vaping Association faulted Gottlieb for not doing more to help "small- and medium-sized businesses" stay open - presumably meaning those selling e-cigarettes, which Gottlieb blamed for hooking a new generation of youth on nicotine.
"Commissioner Gottlieb has laid the groundwork to move forward on these initiatives, but we are concerned because FDA doesn't tend take bold actions without a Commissioner".
"It's my belief that we've been successful in this country at stigmatizing tobacco products among kids", Gottlieb said in April.
While many have praised Gottlieb for his time at the FDA, consumer advocacy group Public Citizen has a differing opinion.
Gottlieb's pet projects at the FDA included expediting generic drug approvals in an effort to fight higher costs, creating new frameworks for getting digital health technologies and cellular and genetic therapies to market, and cracking down on the e-cigarette and tobacco industries. He also held positions with two venture capital firms, T.R. Winston and New Enterprise Associates, after ending his first stint at the FDA, where he served as a deputy commissioner during the administration of George W. Bush.
In a note, analysts at Deutsche Bank said Gottlieb's departure was "rather abrupt and surprising", given that he had denied intentions to leave the FDA two months ago.
FDA leaders have usually centered a lot of their consideration on a handful of medical subjects, however, Gottlieb has been energetic and aggressive on many points as commissioner without hewing to a strictly conservative or liberal ideology.
But Gottlieb's proponents say he was willing to propose ambitious, practical new ideas in an era of political stasis.
Shehan said that Gottlieb's tenure at the FDA compared with those of previous commissioners has been "a pretty stark contrast" in terms of "what he's done and been willing to do to make the drug market more competitive".