FDA Chief to Resign Next Month After Successful Tenure

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Gottlieb leaves in the midst of the teen vaping battle and the opioid crises.

During Gottlieb's tenure, the FDA began cracking down on e-cigarette sellers and manufacturers after surveys showed sharp increases in teen use of vaping products.

Previously, he was a Resident Fellow at the American Enterprise Institute, and a Clinical Assistant Professor at the New York University School of Medicine in Manhattan, where he also practiced medicine as a hospitalist physician.

He noted that "a record number of generic medicines, novel drugs, and novel devices" had been approved in 2017 - and that FDA beat that record in 2018.

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"One of the barriers to competition that concerns me the most is when companies game the system by taking advantage of certain rules and laws", Gottlieb said in early May. "Not surprisingly, his tenure as commissioner 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".

Gottlieb said these protests had no role in his departure.

Analysts also highlighted that the tobacco products division of the FDA was "clearly moving down a path toward greater restrictions", particularly in regard to combustible products (i.e. normal cigarettes) and flavoured e-cigarettes. "But they were just proposals".

As it relates to the USA tobacco industry, the change in FDA leadership "puts up for debate what the agency has been discussing and exploring as Commissioner Gottlieb has become synonymous with the actions of the FDA", but it was not clear if its was controversy over any aspect of the multifaceted FDA controversies had led to his departure. "As such, for CBD to be legally marketed as an ingredient in a food or dietary supplement, the law requires that the FDA first would need to issue a regulation to permit such marketing", he said.

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"We think this major development will be broadly viewed as a positive for the tobacco industry, although this introduces some uncertainty", Bonnie Herzog, a managing director of equity research at Wells Fargo Securities, wrote in an email to clients. "We haven't been effective stigmatizing e-cigarette use".

In January, Gottlieb said in a tweet that he did not plan to leave the agency after speculation that he planned to step down.

On food safety, Gottlieb's record was mixed.

The commissioner didn't provide a specific reason for leaving in his letter, though The Associated Press reported he cited "the challenge of being apart from my family" in a note to staffers. "We've got a lot important policy we'll advance this year".

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Health and Human Services Secretary Alex Azar praised Gottlieb as "an exemplary public health leader, aggressive advocate for American patients, and passionate promoter of innovation" in an emailed statement.