Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), poses for portrait photographs in front of the old FDA sign at the FDA in White Oak, Md, Nov. 5, 2018.
The Washington Post/Getty Images
By Margaret Talev, Anna Edney, and Bloomberg
Updated: March 5, 2019 3:56 PM ET

U.S. Food and Drug Administration Commissioner Scott Gottlieb is resigning, ending a tenure at the agency where he approved a flood of new drugs and cheaper copycat pills, and pushed for sharp curbs on e-cigarette use to halt what he called an epidemic of youth use.

A senior FDA official said his resignation had been planned for some time, and that he was leaving the Trump administration on amicable terms. Gottlieb, 46, had grown tired from a long commute each week back and forth to Connecticut, according to the person, and he felt like he’d set in motion many of his goals on drug costs and e-cigarettes.

Another person familiar with his thinking said Gottlieb had also been frustrated by the government shutdown that shuttered many of the agency’s activities for about a month.

Under his watch, approvals for totally new drugs soared to 59 in 2018 from just 22 in 2016, the last year of the Obama administration. He was also a key part of the Trump administration’s push to lower pharmaceutical costs. Those efforts focused on approving hundreds of new generic drugs, as well as targeting industry tactics that he and others blamed for keeping prices high.

The departure of the high-profile regulator reverberated in the stock market. Shares of smaller, innovative drug companies, which have benefited from Gottlieb’s efforts to modernize the drug-approval process for novel therapies, slipped on the news, with the Nasdaq Biotechnology Index falling 0.3 percent after earlier trading in positive territory.

Gottlieb also targeted the growing youth use of e-cigarettes. After initially favoring e-cigarettes and vaping devices as a way to help smokers quit, the agency became alarmed by a sudden rise in youth use. That led to proposals for restrictions on e-cigarettes, including limiting access to flavors and places where the devices could be sold.

Tobacco-company stocks briefly jumped higher, a signal that some investors see Gottlieb’s departure as a possible opening for a more relaxed regulatory regime. Altria Group Inc., which has a large stake in vaping company Juul Labs Inc., gained as much as 2.7 percent in afternoon trading in New York.

In his resignation letter, Gottlieb trumpeted the FDA’s recent success in rolling out policies to address youth tobacco use and opioid addiction, and touted the brisk pace of new drug approvals by the agency. He said the FDA had expanded access to lifesaving drugs for patients with terminal illness on his watch.

Gottlieb said the agency had responded well to drug and device shortages in the aftermath of Hurricane Maria, which devastated health-industry operations in Puerto Rico, and that it had kept its most critical operations running smoothly during the government shutdown.

“We’ve taken notable enforcement actions to confront bad actors that put Americans at risk,” Gottlieb wrote, highlighting agency crackdowns on bogus stem-cell therapies as well as unsafe medical devices and dietary supplements.

Health and Human Services Secretary Alex Azar praised Gottlieb as “an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation” in an emailed statement. Azar lauded Gottlieb’s record on drug approvals, opioids and tobacco.

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