US Food and Drug Administration Commissioner Scott Gottlieb, a well-liked figure who helmed the country’s top food and drug regulator for just under two years, is resigning.
The surprise announcement was made on Tuesday. Gottlieb, who is reportedly resigning to spend more time with his family, will step down from the office in about a month. The Washington Post first reported the news.
It has been difficult for Gottlieb, who has three young children, to commute back and forth weekly between Washington, DC and his home in Connecticut, according to the Post.
Gottlieb had been a vocal critic of popular e-cigarette startups like Juul, which he has repeatedly slammed for its popularity among teens.
Gottlieb has also won both praise and criticism for the FDA’s speedy approval of many new drugs, including low-cost generic medicines.
In a resignation letter dated Tuesday, Gottlieb named taking action against “bad actors that put Americans at risk” as among the FDA’s accomplishments while under his leadership.
“We cracked down on bogus stem cell therapies, on sham homeopathy, on unsafe medical device products, on tobacco sales to minors, on unsafe dietary supplements, and on kratom,” he said in the letter.
Gottlieb also thanked FDA staffers in the letter, and his family “for their support in enabling me to take on the privilege of serving in this role.”
Both President Donald Trump and Alex Azar, secretary of the US Department of Health and Human Services, have praised Gottlieb and his work since the announcement.
Azar called him “an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation” on Tuesday.
“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” Azar said in a statement. “The public health of our country is better off for the work Scott and the entire FDA team have done over the last two years.”
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Gottlieb’s resignation could endanger some of the FDA’s work on e-cigarettes and tobacco, which “was a personal priority for him,” Raymond James analyst Chris Meekins said.
“Other initiatives Gottlieb has undertaken will continue because his staff is still running the agency, but progress will likely slow,” he said. “The unexpected nature of this should not lead to overreaction. FDA has operated without a permanent commissioner before and can do so again.”
Under Gottlieb’s leadership, the FDA asked a pharma company to take its opioid medication off the market, after the regulator found that its benefits did not outweigh the risks. The regulator has also taken a number of other actions targeting the opioid crisis, including cracking down on online websites selling illegal products.
The FDA did, however, approve a new opioid product over the objections of health advocates, who worried about putting a potent and addictive medication on the market in the midst of the US’s opioid crisis.
Gottlieb, who is 46, had a long career in the healthcare industry before starting at the FDA. A physician, he also was a venture partner at venture capital firm New Enterprise Associates. Gottlieb had also previously served at the FDA, as deputy commissioner during George W. Bush’s presidency.
Lydia Ramsey contributed reporting.
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