In Scott Gottlieb's Final Weeks as FDA Commissioner, Tying Up Loose Ends

In one of his final interviews in his last few weeks at the FDA, Commissioner Scott Gottlieb, MD, discussed where the food and drug regulator stands on its continued push against the tobacco industry as well as what we can expect next from Gottlieb.

The interview, held at the Hutchins Center on Fiscal & Monetary Policy and the USC-Brookings Schaeffer Initiative for Health Policy at the Brookings Institution, was conducted by Anna Edney, health policy and FDA reporter at Bloomberg News. Gottlieb was asked when he believes the FDA will be able to publish a proposed rule around lowering nicotine levels in tobacco products to where they’re no longer addictive.

Gottlieb spoke in generalities, saying that the FDA “may be able to move it out later this summer—to review by HHS.” Though he told the crowd not to hold tight to that timeline, as things could be subject to change. According to Gottlieb, “big” rules such as this typically undergo long review processes. After the proposed rule is sent to HHS, he said it would be hard to predict how long HHS would review it for, but after that, the FDA would have to allow for at least a 90-day comment period. “The average time for a rule from proposed to final is 2-3 years. Highly complex rules that are also highly novel, the process is even longer,” he said.

Gottlieb was more forthcoming about the current state of the vaping epidemic amongst today’s youth. In December 2018, Altria Group Inc announced that it was taking a $12.8 billion stake in Juul, maker of arguably the most popular pod-based vaping device, at the same time that both companies had notified FDA that they intended to increase efforts to keep kids from getting hooked on e-cigarettes.

The FDA chief called a meeting with the companies just last week to provide answers.

“It was a difficult meeting as far as meetings have gone. I’ve had less than 10 meetings [throughout my tenure at FDA] with manufacturers. I can’t remember a meeting with a single manufacturer that wasn’t with a tobacco company…I continue to have concerns that some of the activities they’re partaking in the market aren’t necessarily consistent with what they’re telling us and the existential threat of this category [e-cigarettes],” he said.

Gottlieb went so far as to say that he’s in debates currently around whether flavored e-cigarette products, or any e-cigarettes at all, should be sold in convenience stores. The FDA will be anxiously awaiting data from the youth tobacco survey that is presently being conducted before deciding, in Gottlieb’s words, whether to take action against the entire category of products. “If you see youth cigarette use go up 40%—which isn’t out of the question—if you see levels of overall tobacco use of 40% to 45%... FDA will have to carefully contemplate action against the category. I went back looking at data to the 1950s and we haven’t seen this level of addiction since then. All dramatic gains we’ve made in decreasing tobacco usage will be reversed from these products,” said Gottlieb.

Switching gears, he also explained that his last day at FDA will be April 5, leaving time for him to testify before the House and the Senate on the budget prior to his departure. Edney questioned Gottlieb on his reasons for resigning, citing a January 3 tweet in which Gottlieb wrote that he wants “to be very clear— I’m not leaving,” prior to resigning just 2 months later.

Gottlieb deflected by saying that comment was in response to an article that had ventured that he was leaving during the government shutdown that lasted from December 22, 2018, to January 25, 2019, the longest shutdown in history. “People have been speculating on this because you can’t possibly leave because you just miss your family…this was an incredibly hard decision to make. But I did this [job] for 2 years and it was hard on my family. I wouldn’t leave if the agency wasn’t in a good place. We’ve had a lot of policy laid out and rolled out and I feel good about where the agency is right now. We’ll finalize things later this month before I leave that are highly meaningful.”

When asked if he believes that the FDA will have another permanent commissioner under the Trump administration, Gottlieb was hopeful, though he said it really depends on the Senate calendar. “I’ve been quite vocal that I’m a big fan of Ned Sharpless (recently named acting FDA commissioner). He’s met with a lot of folks at FDA already, he’s met with me a few times as well. The decision is up to the [HHS] secretary and ultimately the president.”

Finally, when asked what the public can expect next from the soon-to-be former FDA commissioner, Gottlieb said he hasn’t given a lot of thought to his next professional venture, but he did have some plans for how he’d spend his time immediately following his last day. “I have the week off after I leave the job and then it’s my girls’ spring break. We asked what they wanted to do—and not many people can say this—but of course, they wanted to go to Disney World, so I’m going to Disney World.”