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In his almost two years as FDA Commissioner, Scott Gottlieb has overseen a crackdown on the tobacco industry and on electronic cigarettes. It's an effort he hopes the agency will continue after he steps down in April.

. If that continues, he tells NPR's Steve Inskeep, the FDA should consider banning them. 


Manufacturers of e-cigarettes have promoted them as a way to help smokers taper off and quit cigarettes, but there's no conclusive scientific evidence that they work for long-term smoking cessation. The FDA had once hoped e-cigarettes would give adults a safer way to get nicotine while they tried to quit, and as such, decided to allow companies to sell those products without first proving a net public health benefit.

"We set out on that at a time when youth use of these cigarettes wasn't at epidemic levels," he tells NPR. "Now that we're seeing epidemic growth in the use of these products by kids, that changes the equation."

As he prepares to leave the agency, Gottlieb told Inskeep about his efforts to regulate the tobacco and pharmaceutical industries.

On e-cigarettes and that kids are vaping in large numbers

That bothers me an awful lot. Even if you're able to help a portion of currently addicted adult smokers migrate off combustible tobacco, when you look at that against all the youth use that's being created by these e-cigarettes, I think you're getting to a point where you have to ask yourself whether or not the availability of these e-cigarettes has redeeming public health value.


I think if we see the numbers of kids using these e-cigarettes go up again in 2019 in the 

 [due this summer] ... but if we see a big increase again, year over year, like we saw last year, I think the FDA is going to have to contemplate whether they ban the pod-based products [like JUUL] as a category. And the ban would be to require the companies to come in with applications to get these products on the market. 





Remember, these products are on the market out of an exercise of enforcement discretion by the FDA. They don't have those applications in. They haven't even submitted them. No company has submitted an application for an e-cigarette.

We've set out on a lot of efforts to try to bring more product competition into the market to try to lower costs. I see as my role in FDA and FDA's role in the drug cost debate – trying to create more product competition so that hopefully if you have a viable marketplace you can have price competition. 

We've opened up vehicles for more generic competition in places where I think branded companies were gaming the system to block generic competition. We've also looked at the issue of branded competition where over time what you've seen is new drugs have monopolies for longer periods of time before the second drug comes to market in that category. 

We have a very careful balancing in our market right now where we allow branded companies to have limited monopolies to earn returns on the risk-taking and the investment they make, but once those monopolies, once those patents are up, we expect there to be vigorous competition. And if that vigorous competition can't enter the market once that patent term has expired, that delicate compromise that we engage in as a society falls apart.

On the industry pressure an FDA head can feel

I think you just have to take it. I knew coming into this job that I was going to get a lot of criticism for certain decisions. I knew I was going to be the subject of negative campaigns. And what I told myself was I can't allow outside pressure of my own ideology to affect how I execute that mission. 

I didn't take meetings with individual sponsors in the role I was in. I made a conscious decision not to do that. I felt those meetings should be happening at the level of the professional staff – people who are in a better position to adjudicate ... what they're being told. I didn't think it was the job of the commissioner to be directly lobbied ... or take direct meetings with regulated entities when the decision-making really has to happen at the professional staff level. 

Heidi Glenn adapted this interview for the Web.

Health

Steve Inskeep

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Food and Drug Administration Commissioner Scott Gottlieb talks about his efforts to regulate the tobacco and pharmaceutical industries. He's set to leave his post next month.

FDA's Gottlieb: More kids vaping 'changes the equation' for e-cig regulation

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