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FDA Commissioner Dr. Scott Gottlieb to resign next month

US Food and Drug Administration Commissioner Dr. Scott Gottlieb said in a letter to staff on March 5, 2019, that he will be leaving the agency.

US Food and Drug Administration Commissioner Dr. Scott Gottlieb said in a letter to staff Tuesday that he will be leaving the agency.

“It’s is hard for me to write this note to share with you the news that I’ll be leaving my job as the Commissioner of Food and Drugs in the next month. There’s perhaps nothing that could pull me away from this role other than the challenge of being apart from my family for these past two years and missing my wife and three young children,” says the letter, which the FDA tweeted.

An administration official familiar with the situation said the move has been in the works for several months. Gottlieb has been commuting weekly to Washington from his home in Connecticut and is leaving to spend more time with his family, the official said.

Gottlieb tweeted that he is “grateful for the opportunity to help lead this wonderful agency.”

Gottlieb previously served as the agency’s deputy commissioner for medical and scientific affairs. After he was appointed by President Donald Trump, he was sworn in as the 23rd commissioner on May 11, 2017.

Alex Azar, secretary of the Department of Health and Human Services, the FDA’s parent agency, said in a statement Tuesday that Gottlieb “has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation.”

During his tenure as commissioner, Gottlieb approved a record number of treatments and drugs and advanced policies to confront opioid addiction and prevent youth e-cigarette use. He also faced the longest government shutdown in history.

In April, Gottlieb told CNN Chief Medical Correspondent Dr. Sanjay Gupta that opioids are the biggest crisis facing the FDA. He also said tobacco and e-cigarette use among youths must be curtailed. Since then, he has been on a mission to curb teen vaping, which is now deemed an epidemic.

He has been particularly aggressive on the issue of e-cigarette use, targeting convenience stores that sell vaping products, aiming to limit the access and appeal these products have for children.

“It’s my belief that we’ve been successful in this country at stigmatizing tobacco products among kids,” Gottlieb said in April. “We haven’t been effective stigmatizing e-cigarette use.”

Azar said Tuesday that “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.”

Trump also tweeted about Gottlieb’s planned departure, saying he’s done a “absolutely terrific job.”

“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!”

In his tweet, Gottlieb thanked both Azar and Trump for their support: “This has been a wonderful journey and parting is very hard.”

Gottlieb previously worked as a senior adviser to the Centers for Medicare and Medicaid Services and was appointed by the Senate to serve on the Federal Health Information Technology Policy Committee.

Before these appointments, he served as a clinical assistant professor at the New York University School of Medicine in Manhattan, where he also practiced medicine as a hospitalist physician.

He completed a residency in internal medicine at the Mount Sinai Medical Center in New York and is a graduate of the Mount Sinai School of Medicine and of Wesleyan University in Connecticut, where he studied economics.

Gottlieb is also a cancer survivor, a venture capitalist and a government insider who long said he wanted to tear down the wall of FDA regulations that he believes is holding back innovation.

Not everyone is praising Gottlieb’s tenure.

The advocacy group Public Citizen said in a statement Tuesday that his time as the agency’s head “was marked by regulatory decision making regarding medications and medical devices that tilted further in favor of industry’s financial interests rather than the interests of public health.”

The group cited the controversial approval in April of an opioid called Dsuvia, which is 10 times more powerful than fentanyl.

Gottlieb said at the time that “The agency is taking new steps to more actively confront [the nation’s opioid] crisis, while also paying careful attention to the needs of patients and physicians managing pain.”

Public Citizen called the approval a “reckless decision” along with the “withdrawal of a proposed rule that would have allowed generic drug companies to promptly update their labels with new warnings.”

In the letter to FDA staff, Gottlieb said that “the work that binds us is a shared mission is inspiring” and that “the opportunity to serve in this role was a privilege.” He noted that he’ll continue working on new policies and enforcing laws to protect consumers and “improve the lives of Americans.”

Gottlieb concluded by saying the agency is strong and thanking his family “for their sacrifice over the past two years.”

By Susan Scutti, Jeremy Diamond and Debra Goldschmidt, CNN

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