FDA Commissioner Scott Gottlieb Announces Resignation

Posted March 6, 2019

Scott Gottlieb, the commissioner of the Food and Drug Administration (FDA), has announced that he will resign from the agency effective next month. During his nearly two years of service, the FDA worked to streamline the regulation of medical devices, partnering with industry to help advance new technologies while maintaining patient safety.

Gottlieb also presided over this year’s protracted government shutdown, which strained the agency’s resources and its workforce. During that time, he used Twitter prolifically to keep the public—and his own employees—informed about FDA operations.

In his resignation letter, Gottlieb cited “historic” approvals of novel medical devices in addition to efforts to “modernize the development process for novel medical technologies.”

"We forged a new breakthrough pathway for novel devices that promote safety and undertook historic modernizations of the 510(k) process,” Gottlieb wrote, while also taking enforcement actions against “bad actors.”

According to a Washington Post report, Gottlieb, 46, decided to leave the FDA to spend more time with his family, including his three young daughters. As commissioner, he commuted to the FDA’s White Oak, MD, campus from his home in Connecticut.

“It was a very hard decision … this is the best job I will ever have,” Gottlieb told the Washington Post. “I get home late Friday, work on weekends, and come back to Washington on Sunday. I did the job 100 percent."

Alex Azar, secretary of the Department of Health and Human Services, praised Gottlieb’s “remarkable work” as commissioner.

“He has been an exemplary public health leader, aggressive advocate for American patients, and a passionate promoter of innovation,” said Azar in a statement. “Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of … innovative treatments.”

In addition to Gottlieb’s work with medical devices, he also advanced policies to reduce generic drug prices, as well as curb opioid addiction and tobacco use.