- Scott Gottlieb, the head of the Food and Drug Administration, is stepping down from his office in about a month, after just under two years in the job.
- The announcement, made on Tuesday, came as a surprise to many.
- Gottlieb has been a vocal critic of e-cigarette startups, such as Juul, which he has repeatedly slammed for its popularity among young people.
- He also presided over the speedy approval of many new drugs and is well-liked in the pharmaceutical community.
- In his resignation letter, Gottlieb said taking actions against “bad actors that put Americans at risk” was among the FDA’s accomplishments while under his leadership.
US Food and Drug Administration (FDA) Commissioner Scott Gottlieb, a well-liked figure who helmed the country’s top food and drug regulator for just less than 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, such as 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 his resignation letter on Tuesday, Gottlieb named taking action against “bad actors that put Americans at risk” 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.
In the letter, Gottlieb thanked FDA staffers and expressed gratitude to his family “for their support in enabling me to take on the privilege of serving in this role.”
Here's Gottlieb's resignation letter pic.twitter.com/pMfEhCIURM
— Zach Brennan (@ZacharyBrennan) March 5, 2019
Both President Donald Trump and Alex Azar, the secretary of the Department of Health and Human Services, praised Gottlieb and his work after the announcement.
….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!
— Donald J. Trump (@realDonaldTrump) March 5, 2019
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.”
Gottlieb’s resignation could make some of the FDA’s work on e-cigarettes and tobacco “take a back seat as that was a personal priority for him,” the 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 pharmaceutical 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 despite objections from health advocates, who worried about putting a potent and addictive medication on the market in the midst of the US’s opioid crisis.
Gottlieb, 46, had a long career in the healthcare industry before starting at the FDA. A physician, he also was a venture partner at the 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.