Scott Gottlieb is leaving the FDA. He was the most aggressive anti-tobacco leader in years. – Vox.com


Tobacco stocks jumped on Tuesday when news broke that Scott Gottlieb, head of the Food and Drug Administration, would resign at the end of the month.

Gottlieb, a doctor and former venture capitalist, came into the Trump administration in 2017, with strong ties to the industries he was supposed to steer and a history of writing anti-regulatory screeds in conservative journals. Critics wondered if he was right for the job.

But the 46-year-old cancer survivor quickly proved himself to be an outspoken advocate of public health, making tobacco and teen vaping his signature issues during his 23-month run. “He embraced science and embraced the goals of the agency,” said Peter Lurie, the president of the Center for Science in the Public Interest. “That can’t be said for many of the other [Trump] appointees.”

Gottlieb railed against smoking as the leading cause of preventable death in the US, and proposed innovative policy solutions to reduce the health harms of tobacco (such as nicotine limits and a menthol ban). As new dataemerged that showed America was in the midst of a teen vaping epidemic, fueled in part by the vape device Juul, he went after the company and proposed ways to curb the problem through his Youth Tobacco Prevention Plan.

These efforts are a big part of why his resignation has been met with disappointment and concern from the medical and public health communities.

More reason to wonder about Gottlieb’s departure: “Tobacco stocks immediately jumped on the news. Shares of Altria Group rose 1.2% while shares of British American Tobacco traded in the U.S. were up by almost 2%.”

— Hank Greely (@HankGreelyLSJU) March 5, 2019

“Gottlieb was as aggressive in taking on tobacco as any FDA leader of the last 20 or 25 years,” Andrew Hyland, chair of the department of health behavior at Roswell Park Comprehensive Cancer Center, told Vox.

“[The] resignation throws into question how the FDA will continue to chart a path forward on smoking harm reduction,” said Amy Fairchild, a tobacco control expert at Texas A&M University.

Terrible news for public [email protected] is resigning as head of @US_FDA

Scott has been a ray of sunshine — advocating for vaccines, smarter drug policy, more generics, tackling vaping and tobacco

Let’s hope the next Commissioner is half as goodhttps://t.co/w91BhOvf45

— Ashish K. Jha (@ashishkjha) March 5, 2019

Industry watchers are betting that big tobacco will benefit from Gottlieb’s exit. Here’s the note Bonnie Herzog, managing director and senior analyst of the tobacco, beverage, and convenience store industries at Wells Fargo Securities, sent out yesterday, about why she expects “tobacco stocks to react favorably to this news”:


Scott Gottlieb is leaving the FDA. He was the most aggressive anti-tobacco leader in years. - Vox.com

Bonnie Herzog/Wells Fargo

The reason Gottlieb gave for stepping down is that he wanted to spend more time with family, and commuting between Washington, DC, and the Connecticut home he shares with his wife and three children was proving difficult. So far, White House officials are denying that he was asked to leave, and there are rumors that he might even be asked to take another post in the administration, according to the Washington Post.

As Michael Eriksen, a former director of the Centers for Disease Control and Prevention’s Office on Smoking and Health, told Vox, Gottlieb was “widely recognized as a star in the current administration,” the Trump official everybody seemed to like.

Scott Gottlieb, who has done an absolutely terrific job as Commissioner of the FDA, plans to leave government service sometime next month….

— Donald J. Trump (@realDonaldTrump) March 5, 2019

But there’s the lingering question of what Gottlieb’s resignation will mean for the range of vaping and tobacco regulations he was pursuing. “Commissioner Gottlieb has made several bold proposals that, if implemented, have the potential to save more lives from tobacco use than the actions of any previous administration,” said Matt Myers, president of the Campaign for Tobacco-Free Kids, in a statement. But, he continued, “to date, none of his proposals have been adopted.” Here are the top three smoking and vaping initiatives that are now in peril.

1) Gottlieb wanted to make America the first country to limit nicotine in cigarettes

In March 2018, Gottlieb announced a bold move — he wanted the US to go where no other country had gone before and put in a place a regulation that would set a maximum amount of nicotine cigarettes can have. That means America could become the first country in the world to force tobacco companies to reengineer their products to be less addictive.

Gottlieb first announced the measure as part of his comprehensive plan for tobacco and nicotine regulation. And the March notice of proposed rulemaking was the first real step in initiating the long, bureaucratic process that could make the regulation a reality.

“We believe the public health benefits and the potential to save millions of lives, both in the near and long term, support this effort,” Gottlieb said in a statement at the time.

In fact, researchers who modeled the health impact of nicotine limits for a new paper in theNew England Journal of Medicineshowed the policy could help some 5 million adult smokers quit smoking within one year, and by 2100 prevent more than 33 million people from becoming regular smokers at all.

According to the model, smoking rates could drop from 15 percent to as low as 1.4 percent, Gottlieb said then. “All told, this framework could result in more than 8 million fewer tobacco-caused deaths through the end of the century — an undeniable public health benefit.”

Cigarette use has been on a downward trajectory for decades in the US thanks to tobacco taxes, smoking bans, and public awareness campaigns. But smoking is the leading cause of preventable disease and death in America, contributing to nearly half a million early deaths and more than $300 billion in health care expenditures and productivity losses every year. The nicotine limit could change that trajectory.

The proposal was expected to take years to get enacted: There were nine steps in the regulatory process — and that’s without any litigation. But, said Eriksen, “while always an uphill battle, [Gottlieb] was committed to it.” Now, he added, it’s “doubtful that a new commissioner will be as committed.”

2) He pushed a ban on menthol cigarettes and other flavors

In another public health power move, Gottlieb announced several crackdowns on cigarette and vaping flavors.

Researchers have long known menthol cigarettes are more attractive to youth and harder to quit than regular cigarettes. They’ve also been heavily marketed to — and are especially popular among — black smokers.

With the rise of vaping, flavors in e-cigarettes have attracted scrutiny: From mango cucumber and creme brûlée, they’re widely viewed as appealing to teens, not adult smokers who were looking to quit.

In November, Gottlieb said the FDA would be moving on the flavor problem, to ban menthol cigarettes and flavored cigars from the market, and sharply restrict the sales of flavored e-cigarettes in stores and online.

“I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes,” he said in a statement at the time. “Moreover, I believe that menthol products disproportionately and adversely affect underserved communities.”

The e-cigarette restrictions FDA was pursuing will allow retailers to continue selling flavored vape products, but in age-restricted, zoned-off areas. For products sold online, the agency wanted to heighten age verification requirements.

While these moves fell short of the all-out ban on flavored cartridge-based e-cigarettes in thousands of convenience stores and gas stations across the US that many anticipated, they were applauded because they came at a pivotal moment: Vaping seemed to be going viral in teens, who were quickly adopting products like Juul, a device that burns flavored pods.

Now it’s unclear what’ll happen with the flavor restrictions. “Those that stand to benefit most from Gottlieb’s resignation are cigarette manufacturers who have been lobbying Congress to stop FDA’s plan to ban menthol cigarettes,”said Cristine Delnevo, the director of Rutgers’s Center for Tobacco Studies, “a move that could save hundreds of thousands lives, and millions of health care expenditures.”

3) He shined a light on the youth vaping epidemic and the harms of nicotine

In a candid September 2018 letter, Gottlieb announced that the FDA would intensify its crackdown on e-cigarettes in the face of what he called an “epidemic” of teen use. “I use the word epidemic with great care,” he wrote. “E-cigs have become an almost ubiquitous — and dangerous — trend among teens.”

The letter came out ahead of new data from the National Institutes of Health survey, which tracked substance use among American adolescents. It found that the number of high school seniors who say they vaped nicotine in the past 30 days had doubled since 2017 — from 11 percent to nearly 21 percent. That was the largest increase ever recorded in any substance in the survey’s 43-year history. And it meant a quarter of 12th-grade students are now, at least occasionally, using a nicotine device that’s so new we have no idea what the long-term health impacts of using it could be.

Gottlieb also gave voice to the worry among doctors and health officials about the immediate harmful side effects of nicotine on young people’s developing brains and bodies. The “nicotine in these products can rewire an adolescent’s brain, leading to years of addiction,” he said. He also pointed out that there’s strong evidence that vaping may encourage young people to try cigarettes.

“Gottlieb has been one of the most vocal and able proponents of public health, especially among kids,” said Roswell Park’s Hyland. “His leadership in informing the country about the youth vaping epidemic and its consequences has been especially clear and impactful.”

A dark spot on Gottlieb’s track record

But Gottlieb’s track record on vaping wasn’t flawless. Before tackling it, early on in his tenure, he delayed the compliance deadline for the regulation of e-cigarettes until 2022. This gave e-cigarette manufacturers that had products on the market before 2016five more years to file public health applications that showed their products were safe alternatives to conventional cigarettes and that they weren’t unduly targeting minors. It also meant companies like Juul got a free pass.

Gottlieb positioned the delay as a way to give manufacturers time to get in step with the new laws while ensuring smokers had access to cigarette alternatives that could save their lives — and won over the harm reduction community that felt e-cigarettes play an important role in curbing smoking.

But some public health advocates viewed the move as a chance for e-cigarette makers to further expand their market share among kids at a time when e-cigarette in teens has eclipsed conventional cigarette use.

For these reasons, health groups sued the FDA over the delay and sent a letter to Gottlieb asking the FDA to begin to regulate e-cigarette products like other cigarettes immediately and outlaw the marketing of flavored products to youth — both of which never happened.

Still, Richard Miech, a public health professor at the University of Michigan who’s been tracking the teen vaping epidemic, worried the picture could look even worse after Gottlieb leaves.“Vaping is now a multibillion-dollar industry, and companies that are willing to addict children to nicotine stand to make a lot of money,” he said. “Unless people like Gottlieb stand up for our youth, the alarming increases in teen vaping we have seen in recent years will continue unabated.”

What happens next?


President Trump Delivers Remarks On Lowering Drug Prices In Rose Garden

Scott Gottleib wears socks with skulls to an announcement.
Chip Somodevilla/Getty Images

Well, we don’t really know. The FDA did not respond to Vox’s request for comment on what’ll happen to the anti-smoking and anti-vaping strategies now that Gottlieb is leaving. Gottlieb told the New York Times that he’ll continue to move the needle on these policies over the next few weeks, including the restrictions on flavored e-cigarettes.

It’s important to remember he wasn’t acting alone. The FDA has a solid foundation of leadership at FDA’s Center for Tobacco Products, starting with its director, Mitch Zeller, and other agencies — including the CDC and the NIH — are also taking up anti-tobacco and anti-youth vaping efforts.

But a vacuum of leadership at FDA could mean these issues fall by the wayside there. “[FDA’s] ability to make significant strides in reducing tobacco use is dependent on the continued leadership of the new commissioner and [Health] Secretary [Alex] Azar,” said Gregg Haifley, associate director of federal relations at the American Cancer Society Cancer Action Network. “Any successive commissioner who fails to acknowledge the public health crisis that is resulting from teen use of e-cigarettes and doesn’t continue to advance initiatives to curb use would represent a step backward for the public health of our nation.”

“If the change in leadership was politically motivated, it could signal a lack of support on this issue from above,” said Cheryl Healton, dean of the college of global public health at New York University, “and potentially lack of support for other important issues under FDA jurisdiction.”

Before Gottlieb, Trump was rumored to be considering Silicon Valley insiders with no medical background for the director position, including the super-libertarian PayPal founder Peter Thiel and Balaji Srinivasan, who argued we’d be better off if the agency operated more like a “Yelp for drugs.”

“The likelihood of finding somebody to pick up the reins on [the nicotine limits],” CSPI’s Peter Lurie pointed out, “is small in the current administration.”

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