Shock as Scott Gottlieb resigns from FDA

In an unexpected move, Scott Gottlieb has resigned as Commissioner of the FDA and will be leaving office in around a month.

Gottlieb has told The Washington Post that he wants to spend more time with his family, having spent the last few months commuting from his home in Westport, Connecticut.

The resignation wasn’t sought by the President, who tweeted that Gottlieb will be “greatly missed” and has come as a surprise to FDA officials.

In his resignation letter, Gottlieb highlights the progress the FDA has made in his 23 months at the helm, in tackling tobacco-related health problems, opioid addiction, making drugs more affordable, improving access to new therapies and cracking down on food safety issues. He doesn’t however say anything about his reasons for leaving.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” said US Health and Human Services (HHS) Secretary Alex Azar.

“He has been an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation. 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.”

“Scott’s leadership inspired historic results from the FDA team, which delivered record approvals of both innovative treatments and affordable generic drugs, while advancing important policies to confront opioid addiction, tobacco and youth e-cigarette use, chronic disease, and more,” he added. “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.”

API action

The shock news comes as Gottlieb revealed that the FDA had started applying new powers under the SUPPORT Act that are allowing the agency to take more robust action to restrict the entry into the US of illicit goods that contain active pharmaceutical ingredients (APIs).

The SUPPORT Act is viewed as a key part of the agency’s attempts to crack down on the opioid epidemic, but the powers can be extended to include products containing any type of API.

“This new authority allows us to treat illegal imported articles as drugs when they meet certain requirements, and importantly to stop them as needed, even in the absence of certain evidence of intended use,” said Gottlieb in a series of tweets.

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