FDA Commissioner Scott Gottlieb Steps Down in Surprising Move

SILVER SPRING, Md. — Changes are coming to the Food and Drug Administration (FDA) following the resignation of Commissioner Scott Gottlieb. 

Health and Human Services (HSS) Secretary Alex Azar announced the surprise resignation, which came nearly two years after Gottlieb's appointment to the post, on March 5. His resignation is effective in one month. 

"All of us at HHS are proud of the remarkable work Commissioner Gottlieb has done at the FDA. He has been an exemplary public health leader, aggressive advocate American patients, and passionate promotor of innovation," he said. 

"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. 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," Azar added.

In a tweet, President Donald Trump said Gottlieb did "an absolutely terrific job" and said his talents would be missed.

In response to a twitter posts from Azar and Trump, Gottlieb tweeted, "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 @SecAzar and @realDonaldTrump - This has been a wonderful journey and parting is very hard."

In relation to the overall convenience channel, Geoff Freeman, president and CEO of the Grocery Manufacturers Association, said the consumer packaged goods industry believes in smart, uniform regulation and explained a strong FDA is a critical partner in building consumer trust in products. 

"Under the leadership of Commissioner Scott Gottlieb, the Food and Drug Administration was a strong and effective champion of public health. His candor, transparency and willingness to work together was a welcomed approach in the regulatory environment," Freeman said.

The Commissioner & Tobacco 

Since taking the top position at the FDA, Gottlieb has been focused on reshaping tobacco policy at the federal level. 

In June 2017, the agency unveiled a comprehensive plan for tobacco and nicotine regulation to serve "as a multi-year road map to better protect kids and significantly reduce tobacco-related disease and death," as Convenience Store News previously reported. 

The Comprehensive Plan for Tobacco and Nicotine Regulation placed nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts.

In April 2018, FDA announced several new actions and efforts as part of its new Youth Tobacco Prevention Plan. The actions centered on the increase rise of electronic cigarette use by underage consumers. 

Youth access to e-cigarette and vapor products became a key focal point for Gottlieb and the FDA over the past 11 months leading to several developments, including:

• A "nationwide, undercover blitz" of retail stores and online sites over the summer that resulted in more than 1,300 warning letters and fines to retailers who illegally sold e-cigarette and vapor products to minors.
• A proposal to only allow the sale of flavored tobacco products in age-restricted, in-person locations and, if sold online, under heightened practices for age verification — effectively removing the products from convenience stores.
• A Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.

However, Gottlieb's resignation could hit the pause button on several tobacco proposals, if not add a question mark to them.

"While we share the surprise by the announced resignation of FDA Commissioner Gottlieb … we think this major development will be broadly viewed as a positive for the tobacco industry, although this introduces some uncertainty," said Bonnie Herzog, managing director of tobacco, beverage and convenience store research at Wells Fargo Securities LLC.

"We believe his resignation calls into question whether or not the FDA will in fact enforce harsher regulations around youth e-cigarette usage/access, cigarette nicotine limits and a cigarette menthol ban given he was the champion behind these initiatives," she said

In addition to uncertainty around tobacco regulations, a change in leadership at the agency could affect the future of products trying to come to market, Herzog noted.

"We also believe his resignation could have implications (positive, we hope) for the FDA's approvals of the premarket and modified risk applications for iQOS — long overdue, in our view (and with no clear explanation from the FDA)," according to Herzog. 

With is final day still a month away, Gottlieb still has time to move some of his proposals forwarded, including a plan to remove flavored e-cigarette sales from c-stores — which he reportedly presented to the White House in the past few days, according to NACS, the Association for Convenience & Fuel Retailing.

"At this time, we believe there is no reason to believe that the FDA will back off the as yet, unseen proposal they presented to the White House," said Lyle Beckwith, senior vice president, government relations at NACS. "If anything, we expect the commissioner to spend his final month pushing even harder for it as his legacy achievement."