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

 

RACHEL MARTIN, HOST:

Scott Gottlieb has been commissioner¹ 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 Democrats² and Republicans alike, also with the pharmaceutical³ industry. He is less popular with the makers⁴ of e-cigarettes. He spoke⁵ 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 laymen⁶ 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 addicted⁷ adult smokers⁸ migrate off combustible⁹ 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 redeeming¹⁰ 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 contemplate¹¹ 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 discretion¹² 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 nicotine¹³ and combustible cigarettes, to render them minimally¹⁴ 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 epidemic¹⁵ 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 prescription¹⁶ 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 viable¹⁷ 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 generic¹⁸ 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 administrator¹⁹ 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 ideology²⁰ 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 entities²¹, when the decision-making really has to happen at the professional staff level.

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

1 commissioner   

n.（政府厅、局、处等部门）专员，长官，委员

参考例句：

• The commissioner has issued a warrant for her arrest.专员发出了对她的逮捕令。
• He was tapped for police commissioner.他被任命为警务处长。

2 democrats   

n.民主主义者，民主人士( democrat的名词复数 )

参考例句：

• The Democrats held a pep rally on Capitol Hill yesterday. 民主党昨天在国会山召开了竞选誓师大会。
• The democrats organize a filibuster in the senate. 民主党党员组织了阻挠议事。 来自《简明英汉词典》

3 pharmaceutical   

adj.药学的，药物的；药用的，药剂师的

参考例句：

• She has donated money to establish a pharmaceutical laboratory.她捐款成立了一个药剂实验室。
• We are engaged in a legal tussle with a large pharmaceutical company.我们正同一家大制药公司闹法律纠纷。

4 makers   

n.制造者，制造商（maker的复数形式）

参考例句：

• The makers of the product assured us that there had been no sacrifice of quality. 这一产品的制造商向我们保证说他们没有牺牲质量。
• The makers are about to launch out a new product. 制造商们马上要生产一种新产品。 来自《简明英汉词典》

5 spoke   

n.（车轮的）辐条；轮辐；破坏某人的计划；阻挠某人的行动 v.讲，谈（speak的过去式）；说；演说；从某种观点来说

参考例句：

• They sourced the spoke nuts from our company.他们的轮辐螺帽是从我们公司获得的。
• The spokes of a wheel are the bars that connect the outer ring to the centre.辐条是轮子上连接外圈与中心的条棒。

6 laymen   

门外汉，外行人( layman的名词复数 )； 普通教徒（有别于神职人员）

参考例句：

• a book written for professionals and laymen alike 一本内行外行都可以读的书
• Avoid computer jargon when you write for laymen. 写东西给一般人看时，应避免使用电脑术语。

7 addicted   

adj.沉溺于....的，对...上瘾的

参考例句：

• He was addicted to heroin at the age of 17.他17岁的时候对海洛因上了瘾。
• She's become addicted to love stories.她迷上了爱情小说。

8 smokers   

吸烟者( smoker的名词复数 )

参考例句：

• Many smokers who are chemically addicted to nicotine cannot cut down easily. 许多有尼古丁瘾的抽烟人不容易把烟戒掉。
• Chain smokers don't care about the dangers of smoking. 烟鬼似乎不在乎吸烟带来的种种危害。

9 combustible   

a. 易燃的,可燃的; n. 易燃物,可燃物

参考例句：

• Don't smoke near combustible materials. 别在易燃的材料附近吸烟。
• We mustn't take combustible goods aboard. 我们不可带易燃品上车。

10 redeeming   

补偿的，弥补的

参考例句：

• I found him thoroughly unpleasant, with no redeeming qualities whatsoever. 我觉得他一点也不讨人喜欢，没有任何可取之处。
• The sole redeeming feature of this job is the salary. 这份工作唯其薪水尚可弥补一切之不足。

11 contemplate   

vt.盘算，计议；周密考虑；注视，凝视

参考例句：

• The possibility of war is too horrifying to contemplate.战争的可能性太可怕了，真不堪细想。
• The consequences would be too ghastly to contemplate.后果不堪设想。

12 discretion   

n.谨慎；随意处理

参考例句：

• You must show discretion in choosing your friend.你择友时必须慎重。
• Please use your best discretion to handle the matter.请慎重处理此事。

13 nicotine   

n.(化)尼古丁，烟碱

参考例句：

• Many smokers who are chemically addicted to nicotine cannot cut down easily.许多有尼古丁瘾的抽烟人不容易把烟戒掉。
• Many smokers who are chemically addicted to nicotine cannot cut down easily.许多有尼古丁瘾的抽烟人不容易把烟戒掉。

14 minimally   

最低限度地，最低程度地

参考例句：

• Food spoilage problems occur with minimally processed, concentrated frozen citrus products. 食品的变质也发生在轻微加工的、浓缩冷冻的柑橘制品中。
• So, minimally, they are responsible for such actions and omissions. 所以，至少来说，他们要对这样的行为和忽略负责。

15 epidemic   

n.流行病；盛行；adj.流行性的，流传极广的

参考例句：

• That kind of epidemic disease has long been stamped out.那种传染病早已绝迹。
• The authorities tried to localise the epidemic.当局试图把流行病限制在局部范围。

16 prescription   

n.处方，开药；指示，规定

参考例句：

• The physician made a prescription against sea- sickness for him.医生给他开了个治晕船的药方。
• The drug is available on prescription only.这种药只能凭处方购买。

17 viable   

adj.可行的，切实可行的，能活下去的

参考例句：

• The scheme is economically viable.这个计划从经济效益来看是可行的。
• The economy of the country is not viable.这个国家经济是难以维持的。

18 generic   

adj.一般的，普通的，共有的

参考例句：

• I usually buy generic clothes instead of name brands.我通常买普通的衣服，不买名牌。
• The generic woman appears to have an extraordinary faculty for swallowing the individual.一般妇女在婚后似乎有特别突出的抑制个性的能力。

19 administrator   

n.经营管理者，行政官员

参考例句：

• The role of administrator absorbed much of Ben's energy.行政职务耗掉本很多精力。
• He has proved himself capable as administrator.他表现出管理才能。

20 ideology   

n.意识形态，(政治或社会的)思想意识

参考例句：

• The ideology has great influence in the world.这种思想体系在世界上有很大的影响。
• The ideal is to strike a medium between ideology and inspiration.我的理想是在意识思想和灵感鼓动之间找到一个折衷。

21 entities   

实体对像； 实体，独立存在体，实际存在物( entity的名词复数 )

参考例句：

• Our newspaper and our printing business form separate corporate entities. 我们的报纸和印刷业形成相对独立的企业实体。
• The North American continent is made up of three great structural entities. 北美大陆是由三个构造单元组成的。