Gottlieb to Resign as FDA Commissioner

Regulatory NewsRegulatory News
| 05 March 2019 | By Zachary Brennan 

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb unexpectedly announced Tuesday that he will resign in one month.

In his resignation letter (read it in full below) to Department of Health and Human Services (HHS) Secretary Alex Azar, Gottlieb praised the work that has been accomplished at the agency over the past 23 months, calling himself fortunate to “lead this outstanding team, at this time, in this period of wonderful scientific advances.”

He also noted the agency’s historic modernization of the Office of New Drugs and the Office of the Commissioner.

“We were strong in moments of crisis,” he added, noting the recovery in Puerto Rico and his work during the partial government shutdown. “We’ve taken notable enforcement actions to confront bad actors that put Americans at risk. 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 added.

But his decision to resign was an unexpected one, particularly as he tweeted recently that he was not leaving the agency. And the resignation letter did not offer any explanation as to why he decided to resign. A senior White House official told the Washington Post that Gottlieb had spoken to President Donald Trump, who liked him and did not want him to leave his post.

“Commissioners come, and commissioners go, but Scott Gottlieb hands down has been the best,” Richard Pazdur, director of the FDA’s oncology center of excellence, told the Wall Street Journal.

Azar, meanwhile, praised Gottlieb’s work in a statement: “Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs."

Trump said in a tweet: “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!”



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