More on Policy and Legislation

Scott Gottlieb lauded for tough stance on tobacco and vaping, approval of new drugs at FDA

Policy experts and providers said his charge in the face of the tobacco industry, work to speed drug approvals improved public health.

Beth Jones Sanborn, Managing Editor

Following the surprise announcement of his pending resignation, Scott Gottlieb, the soon-to-be former commissioner of the FDA, is being lauded for his championing of public health, his stance on e-cigarettes and vaping and his service as a physician.

Dr. Gottlieb made the announcement yesterday, saying it was hard for him to leave the position but that it was necessary for his family. He said in a letter tweeted by the FDA that the only thing that could have pulled him away from the job was his family and that he missed his wife and three young children who live in Connecticut. Gottlieb had been commuting to Washington during his tenure at the FDA.

He said he would be working over the next month to ensure the continuance of projects already in progress and to secure the FDA's 2020 budget and that he would be working closely with HHS Secretary Alex Azar.

"This is a very special institution, and the work that binds us in a shared mission is inspiring," he wrote. "I know the opportunity to serve in this role was a privilege and an endeavor that I know I will never be able to replicate in my professional life. … I'll depart knowing that the FDA is strong, its people outstanding and its mission well-recognized and deeply respected across the government, and indeed, across the world."

Previously, Gottlieb served as a senior adviser to CMS and on the Federal Health Information Technology Policy Committee. Before that, he was a clinical assistant professor at the New York University School of Medicine and practiced as a hospitalist physician.

He was sworn in as FDA commissioner in May of 2017 and had previously served as the agency's deputy commissioner for medical and scientific affairs. Initially, his appointment drew some ire over worry about his perceived ties to the pharmaceutical industry, but his hard-hitting stance on public health issues like vaping and use of tobacco products among young people seemed to lend credibility and grit to his image.

Gottlieb's continued pursuit of the issue and his efforts to curb both the access to and the appeal of the devices is one of the stances drawing the most praise for him post-announcement.

Former Acting Administrator for CMS Andy Slavitt praised Gottlieb on Twitter for just that, saying, "Very few have been more boldly willing to take on drug manufacturers and tobacco companies. Tobacco stocks are up on the news that Gottlieb is leaving. Many worries today that his bold agenda against tobacco lacks support."

Bill Barnes, Intermountain Healthcare director of federal government relations, said, "We appreciate the additional focus Scott Gottlieb has brought to drug pricing in the U.S.  His work to further raise awareness about the health issues of smoking and vaping has been very valuable."

Kaiser Permanente Senior Vice President of Government Relations Anthony Barrueta said "Kaiser Permanente commends Dr. Gottlieb for two years of exceptional public service. Dr. Gottlieb's focus on the important influence the FDA has on drug prices was unique among FDA Commissioners. We greatly appreciate his leadership in working to balance the agency's long-standing focus on fostering innovation with policies that help promote access to more affordable medications. We also applaud Dr. Gottlieb's public health leadership in addressing the problem of e-cigarette promotion and use among youth. This is a burgeoning public health threat that demands continued attention."

Secretary Azar joined the chorus for his colleague saying Gottlieb broke new ground for the FDA.

"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," he said. "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."

Group purchasing organization Premier highlighted Gottlieb's efforts to speed drug approvals and address shortages, saying his tenure will have a ripple effect in the pharma space.

"From working to speed approval of generics and biosimilars, to establishing an expedited approval process for shortage drugs, to expediting the approval of new drugs, to cracking down on abuses of Citizen's Petitions and the Risk Evaluation and Mitigation Strategies, to exposing pay-for-delay deals, to undertaking a serious effort to assess and remedy the causes of drug shortages, to advancing real-world evidence, Mr. Gottlieb has left an indelible mark. His work will create greater competition for drugs and reduce their prices," said Blair Childs, senior vice president of public affairs for Premier.

Last month, the American Medical Association honored Gottlieb with the Dr. Nathan Davis Award for Outstanding Government Service. In a statement today, the renowned group praised him for a wide range of efforts, including his work to address the crushing opioid epidemic in the U.S. and the high cost of medications.

"A physician, medical policy expert, and public health advocate, Dr. Gottlieb has been a leader in confronting the challenges our health system faces today," said AMA Board Chair Dr. Jack Resneck Jr. "He has taken decisive action to confront the opioid epidemic, taken on pharmaceutical companies charging high drug prices, and is working to address nicotine addiction and limit youth use of e-cigarettes. As a physician and in public service, Dr. Gottlieb has devoted his career to improving public health and tackling the challenges facing the health system. We hope his successor picks up where he left off."

But advocacy group Public Citizen is among those critical of Gottlieb's tenure at the FDA, saying his decision making was geared more towards the financial interests of the industry rather than safeguarding the public health.

The group specifically cited the approval of an opioid call Dsuvia, which the report said is 10 times more powerful than fentanyl. Gottlieb defended the decision at the time, saying that while the agency was working to combat the opioid crisis, they were also working to help patients and physicians who were trying to manage pain.

Michael Carome, director of the Public Citizen's Health Research Group, said in a statement that, "Scott Gottlieb was entangled in an unprecedented web of Big Pharma ties when he was nominated in 2017 to be FDA commissioner. 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.

"This includes the recent, reckless decision to approve the super-potent opioid, Dsuvia, and the withdrawal of a proposed rule that would have allowed generic drug companies to promptly update their labels with new warnings," he added.

Twitter: @BethJSanborn
Email the writer:

BB9486 adidas Crazy BYW Low AMM Noble Ink