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Scott Gottlieb Resigns from FDA

FDA Commissioner, Scott Gottlieb, Resigns from Post

March 8th, 2019

Wanting More Time to Spend with Family Cited as Main Reason

On Tuesday, March 5, Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration, submitted his resignation to the Trump Administration. Stating that he wants to spend more time with his family, Gottlieb, who has headed the FDA since May of 2017, will be leaving his post sometime in April. During his short tenure, Dr. Gottlieb has focused his efforts on what he calls a nicotine “epidemic” among U.S. teenagers through the use of vaping devices and e-cigarettes.

In a recent interview Gottlieb stated that the weekly commute between his Connecticut home and Washington, D.C. has left him little quality time for his wife and children.

“I’m leaving because I need to spend time with my family,” said Dr. Gottlieb. “I get home late Friday, work on weekends, and come back to Washington on Sunday,” the Commissioner added. “I did the job one-hundred percent.”

Upon reading Gottlieb’s announcement, President Donald Trump tweeted: “. . . 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 addition to his work on fighting teenage nicotine addiction, Gottlieb found himself at the center of regulation controversy between the tobacco industry and the FDA. His aggressive stance on flavored tobacco products includes a proposal to ban menthol and other flavorings from being used in all tobacco products. Should that become a reality, it would have a detrimental impact on many manufacturers. Many state and local governments are now introducing legislation that would restrict availability and sale of any flavored tobacco product, while some have already passed such measures. As to re-evaluating the regulation of imported premium handmade cigars and separating them from other tobacco products, Mr. Gottlieb has re-opened the possibility of doing so, but that decision is still way too uncertain.

Prior to Dr. Gottlieb’s appointment, the FDA said that the lack of a director kept them from properly addressing lawsuits brought by manufacturers after the 2016 Deeming Rule gave the FDA regulatory discretion over the tobacco and vaping industries.

Now that a new FDA Commissioner must be appointed, there’s no reason to believe that Dr. Gottlieb’s replacement will view vaping, tobacco, and for that matter, premium handmade cigars, any differently. It will be even harder to predict the FDA’s policy outcome as it continues its evaluation of the Advanced Notices of Proposed Rulemaking (ANPRM) issued last year with regard to nicotine, flavored and non-flavored tobacco products, and premium cigars. Additionally, the future Commissioner’s impact on the continuing court battle over the Deeming Rule is also unknown.

“All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA,” said of the Department of Health and Human Services Secretary, Alex Azar. “He has been an exemplary public health leader, an aggressive advocate for American patients, and a passionate promoter of innovation. I will personally miss working with Scott on the important goals we share.”