FDA Commissioner Scott Gottlieb has resigned

WASHINGTON – Food and Drug Administration Commissioner Scott Gottlieb has resigned.

“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 President Donald Trump and Health Secretary Alex Azar, Gottlieb tweeted Tuesday. “This has been a wonderful journey and parting is very hard.”

Gottlieb, 46, plans to leave the watchdog agency in a month.

Trump tweeted that Gottlieb had “done an absolutely terrific job” as commissioner: “He and his talents will be greatly missed!”

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

“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,” Azar said in a statement. “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.”

Gottlieb, a physician and venture capitalist, was sworn in as FDA commissioner in May 2017. He previously served as the agency’s deputy commissioner for medical and scientific affairs.

As commissioner, Gottlieb took aggressive steps to curb youth vaping, which he declared an “epidemic” last year, and opioid addiction.

In November, citing a rise in youth vaping that he called “discouraging,” he unveiled plans to sharply restrict sales of sweet-flavored electronic cigarette liquid at convenience stores. The proposed regulatory changes have not yet been implemented.

Gottlieb’s efforts drew praise from consumer watchdog groups that had called for aggressive steps to stem the unfavorable youth vaping trends.

Matthew Myers, president of the Campaign for Tobacco-Free Kids, said Gottlieb’s work is unfinished.

“He initiated a number of potential actions that would have made an extraordinary impact, but he leaves with those actions unfinished,” Myers said. “On e-cigarettes, he deserves credit for shining a spotlight on the crisis of youth e-cigarette use. It will be impossible to reverse that crisis unless the FDA adopts industry-wide rules before he leaves.”

Free-market groups and vaping industry interests have been critical of the FDA efforts under Gottlieb.

“We’ve been complaining and pointing out how the administration’s approach to e cigarettes is not consistent with what president promised on limited regulation,” said Jeff Stier, a senior fellow at the free-market think tank Consumer Choice Center. “What Gottlieb was threatening was over-regulation.”

Stier said Gottlieb’s efforts against e-cigarettes “diverged and diverged dramatically” from the Trump administration’s pledges to limit regulations.

When Stier and others realized that Gottlieb had Azar’s support on vaping, Stier says, they shifted their attention to the White House.

A coalition of more than one dozen conservative groups, including Americans for Tax Reform and FreedomWorks, appealed to the White House this week to intervene to halt Gottlieb’s e-cigarette vaping product restrictions.

In a letter Monday, the groups argued that escalating teen vaping rates had led to “regulatory panic and significant government overreach.” They urged Trump to “pump the brakes” on the FDA’s proposed regulations.

This breaking story will be updated.

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