Scott Gottlieb to step down as FDA commissioner


Scott Gottlieb, MD, will be stepping down from his post as commissioner of the Food and Drug Administration in about a month, according to a statement from the Department of Health & Human Services.

Dr. Scott Gottlieb, commissioner of the Food and Drug Administration

Dr. Scott Gottlieb

According to reports, he is stepping down to spend more time with his family, who live in Westport, Conn. He splits time between there and Washington. He was confirmed by the Senate in May 2017 with five Democrats and one independent joining Republicans in voting him in.

President Trump confirmed Dr. Gottlieb’s resignation, praising him in a tweet for the “terrific job” he has done in this role and commending his efforts to help “us to lower drug prices, get a record number of generic drugs approved and onto the market, and so many other things. ”

Dr. Gottlieb’s legacy may be his work on regulating e-cigarettes, although that work is unfinished. His passion for this subject can be found in a statement made in Nov. 2018, announcing an advanced notice of proposed rule making to regulate e-cigarettes.

“Today, I’m pursuing actions aimed at addressing the disturbing trend of youth nicotine use and continuing to advance the historic declines we’ve achieved in recent years in the rates of combustible cigarette use among kids,” Dr. Gottlieb said in the statement.

More recently, the agency announced March 4 enforcement actions aimed at both retailers and manufacturers, including requesting a meeting with Walgreens to discuss the nearly 1,800 violations the chain has amassed across the country for selling tobacco products to minors.

“Because tobacco use is almost always initiated and established during adolescence, early intervention ‒ including making sure tobacco products aren’t being marketed to, sold to, or used by kids ‒ is critical,” he said in announcing the enforcement actions. He added that the FDA will “continue vigorous enforcement activities, with a sustained campaign to monitor, penalize, and help prevent e-cigarette sales to minors in retail locations, including manufacturers’ Internet storefronts, as well as take additional steps to tackle other concerns related to the youth access and appeal of these products. The FDA is also exploring additional enforcement avenues to target violative sales and marketing practices by manufacturers and retailers.”

The American Heart Association praised Dr. Gottlieb’s work.

“Commissioner Gottlieb departs the FDA having established himself as a tireless champion of tobacco control,” the organization said in a statement. “He elevated the war on tobacco use – and particularly the epidemic of electronic cigarette use among youth – to unprecedented levels. Because of his efforts, millions more people nationwide are aware of the grave threats posed by e-cigarettes and other tobacco products that are addicting a new generation of youth. We urge the FDA in the strongest possible terms to move forward with effective regulation of an industry that continues to prioritize profits over the lives of consumers.”

Department of Health & Human Services Secretary Alex Azar acknowledged Dr. Gottlieb’s work in combating youth e-cigarette use among a number of areas that the outgoing official has had a positive impact on.

“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,” Secretary 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.”

Under his leadership, FDA has approved a record number of generic drugs, although many still are not on the market yet.

In the area of opioids, his tenure could be a mixed bag as the FDA on the one hand removed an opioid product from the market, but on the other, controversially approved a new, powerful one.

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