美国国家公共电台 NPR FDA's Gottlieb: More Kids Vaping 'Changes The Equation' For E-Cig Regulation（在线收听）

RACHEL MARTIN, HOST:

Scott Gottlieb has been commissioner of the Food and Drug Administration for less than two years. When he announced he was stepping down next month, it came as a surprise to many people. He's popular with Democrats and Republicans alike, also with the pharmaceutical industry. He is less popular with the makers of e-cigarettes. He spoke with Steve Inskeep last week about his efforts to crack down on those companies.

STEVE INSKEEP, HOST:

One of the things that we've learned as laymen is that e-cigarettes were promoted as a somewhat healthier alternative to traditional cigarettes, but it seems that what has happened instead is that kids who were not smoking anything are now vaping in huge numbers. Does that bother you?

SCOTT GOTTLIEB: That bothers me an awful lot, and what you said is exactly right. 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 the e-cigarettes has redeeming public health value.

INSKEEP: Should they be banned?

GOTTLIEB: I think if we see the numbers of kids using these e-cigarettes go up again in 2019, in the National Youth Tobacco Survey - which we're in the field doing right now, and we'll have the results in July or August - 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 as a category. And, you know, 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 and have an exercise of enforcement discretion by the FDA. They don't have those applications in. They haven't even submitted them. No company submitted an application for an e-cigarette.

INSKEEP: This is not just a matter of paperwork, right? This means they have not proven to the government's satisfaction that they have a safe and effective product.

GOTTLIEB: Under the law, they haven't proven yet that they provide a net public health benefit. Now, we've exercised enforcement discretion because, remember, we were seeking - and we still are - to regulate nicotine and combustible cigarettes, to render them minimally and non-addictive to try to migrate adult smokers off of combustible tobacco. But we set out on that at a time when youth use of the e-cigarettes wasn't at epidemic levels. Now that we're seeing epidemic growth in the use of these products by kids, that changes the equation.

INSKEEP: What did you think about last year, as you were at the head of the FDA, you're working away, and of course there's a political campaign going on, and again and again and again, voters said their No. 1 concern was health care costs and particularly prescription drug costs?

GOTTLIEB: Well, 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 this - 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.

INSKEEP: Which is hard, right? Because a drug gets patented, and one company dominates that drug for many, many years.

GOTTLIEB: Well, we've opened up vehicles for more generic competition in places where I think the 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, you know, 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.

INSKEEP: When you're the administrator of the FDA, in what ways do you feel the pressure of that industry when you try to get them to change, and who defends you, if anyone, when that pressure is felt?

GOTTLIEB: You know, 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, you know, negative campaigns. And what I told myself was, I can't allow outside pressure and my own ideology to affect how I execute that mission. I have to execute that mission...

INSKEEP: How did somebody do a negative campaign? Was it an outside game of yelling? Was it an inside game of people quietly asking you to dinner? What would happen?

GOTTLIEB: Well, you go on Twitter, and you can see some of the negative campaigns that have been run that sometimes are quite personal. I mean, people invest a lot of money in trying to lobby the agency. But I knew that, you know, the most important thing was to make sure that I follow the professional advice from the career staff at the agency, and that I have direct relationships with the center directors, the real scientific leaders in the agency. And so the first thing I did when I got there was have them report directly to me and schedule weekly meetings with them, where I meet with them every week.

INSKEEP: The professionals?

GOTTLIEB: The heads of the centers. So the head of the drug center, the device center, the tobacco center - I meet with them on a weekly basis. I talk to them almost every day. That doesn't mean that we don't have dialogue with regulated industry; the professional staff do. They ask questions. They collect information. The industry is obligated to do certain studies.

I personally don't have a lot of interactions in my job. 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 happening at the level of the professional staff people who are in a better position to adjudicate those - you know, what they're being told. I didn't think it was the job of the commissioner to be directly, you know, lobbied, if you will, or take direct meetings with regulated entities, when the decision-making really has to happen at the professional staff level.

MARTIN: That was Steve talking with outgoing FDA commissioner Scott Gottlieb.