Scott Gottlieb, the head of the US Food and Drug Administration (FDA), resigned on 5 March and will depart the agency in one month.
Gottlieb, who has led the FDA since May 2017, did not offer a reason for his departure in his resignation letter. “Over the past 23 months, I’ve been privileged to work with an outstanding team,” he wrote. “We were strong in moments of crisis.”
The outgoing FDA chief also won public praise from US President Donald Trump, after news of the resignation broke. “Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month,” Trump tweeted. “Scott has helped us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. He and his talents will be greatly missed!”
Others were less enthusiastic about Gottlieb’s tenure at the FDA. “We’re not unhappy to see him leave,” says Michael Carome, director of the health-research group at Public Citizen, a consumer-activist group in Washington DC. Gottlieb’s tenure as FDA commissioner included decisions that seemed to favour industry rather than public health, he says. For example, the FDA approved an opioid that can be 1,000 times more potent than morphine, leading to concerns that the drug could be misused amid the current opioid epidemic in the United States.
Some agency watchers worry that Gottlieb’s resignation will leave a dangerous void at the FDA, which oversees the safety of drugs, vaccines, medical devices and a large chunk of the country’s food supply.
The FDA commissioner’s departure couldn’t come at a worse time, says Tony Corbo, a senior lobbyist at Food & Water Watch, an environmental non-profit group in Washington DC. “This administration is having a hard time keeping people in key positions to actually run the government,” he says, and Gottlieb’s departure could leave the agency vulnerable during upcoming budget negotiations. Trump is scheduled to release his annual budget request to Congress next week.
Gottlieb, a physician and venture capitalist who has served on the boards of several pharmaceutical companies, became known at the FDA for his aggressive plan to crack down on the sale of flavoured e-cigarettes to curb underage vaping.
On his watch, the Department of Health and Human Services, which oversees the FDA, initiated a review in September 2018 of “all research involving fetal tissue” and “all acquisitions involving human fetal tissue”. The department also cancelled a government contract with a company that supplied fetal tissue to FDA researchers.