Dr Scott GottliebScott Gottlieb, MD
The FDA’s commissioner Scott Gottlieb, MD, has resigned, tendering his resignation to Health and Human Services Secretary Alex Azar in a letter.

According to a report from The Washington Post, the reason given for his resignation, according to an unnamed administration official, was his desire to spend more time with his Connecticut-based family. Gottlieb’s tenure as commissioner lasted less than 2 years, since May 9, 2017, when the Senate confirmed his appointment with a 57–42 vote.

The news of his resignation comes as a relative surprise, as he was considered a popular commissioner by many. Just 2 months ago, the former commissioner noted on his Twitter account that he wanted to be very clear that he was not going to leave the FDA. “We’ve got a lot of important policy we’ll advance this year," he wrote. Gottlieb had advanced a number of programs to address youth cigarette use, improve generic drug approval pathways, and restructure the approval of advanced medicines, among others.

Prior to his time as the head of the agency, he served as a deputy FDA commissioner under former President George W. Bush. He left the FDA in 2007 to serve on the boards of a number of pharmaceutical companies, in addition to working as a resident fellow at the American Enterprise Institute and as a venture capitalist. 

In a statement regarding his resignation, Azar said, “All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA. I will personally miss working with Scott on the important goals we share, and I know that is true for so many other members of the HHS family. The public health of our country is better off for the work Scott and the entire FDA team have done over the last 2 years.”

Gottlieb confirmed his resignation in a statement, in which he noted his desire to spend more time with his wife and 3 young children. He declared his intention to further advance new policies in the coming weeks as he transitions away from the position, in addition to his plans to secure the 2020 administration budget and aid the FDA in moving to new leadership.

"I'll depart knowing the FDA is strong, its people outstanding, and its mission well recognized and deeply respected across the government, and indeed, across the world. I hope to have the opportunity to continue work with you to advance our goals in the weeks before I depart," he stated.

“I’m immensely grateful for the opportunity to help lead this wonderful agency, for the support of my colleagues, for the public health goals we advanced together, and the strong support of Azar and Donald Trump. This has been a wonderful journey and parting is very hard,” he said.

Prior to his role with the FDA, Gottlieb worked as a clinical assistant professor at the New York University School of Medicine, FDA Deputy Commissioner for Medical and Scientific Affairs, and as a venture partner with New Enterprise Associates.

United States President Donald Trump noted in a pair of tweets that Gottlieb had "done an absolutely terrific job as Commissioner of the FDA," adding that he "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!"

Gottlieb sought to tackle various public health issues as FDA commissioner, from youth vaping to opioid addiction and advocated for an improved regulatory process between administration and drug makers. In January, Gottlieb and Jeff Shuren, MD, Director of the Center for Devices and Radiological Health, announced that a record 106 novel devices were approved for the market in 2018. In 2017, the FDA reported a record rate of novel therapy applications filed under priority review (63).

Azar called Gottlieb an “exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”

Gottlieb’s immediate predecessor, Robert Califf, MD, served the Obama administration for less than 1 year after taking office in February 2016, and Califf’s predecessor, Margaret Hamburg, MD, was commissioner May 2009–April 2015.

Note: This is a developing story.
REFERENCE
FDA Commissioner Gottlieb, who raised alarms about teen vaping, resigns. The Washington Post website. https://www.washingtonpost.com/health/2019/03/05/fda-commissioner-gottlieb-who-raised-alarms-about-teen-vaping-resigns/?utm_term=.90e6c4960f47. Published March 5, 2019. Accessed March 5, 2019.