FDA Commissioner Dr. Robert Califf [Photo courtesy of FDA]FDA Commissioner Dr. Robert Califf said industry support will be the biggest factor in keeping talented employees at his agency under President-elect Donald Trump’s administration.

美国食品和药物管理局局长罗伯特·卡里夫博士（照片由美国食品和药物管理局提供）美国食品和药物管理局局长罗伯特·卡里夫博士表示，在当选总统唐纳德·特朗普（DonaldTrump）的管理下，行业支持将是留住其机构优秀员工的最大因素。

In an interview today at the Friends of Cancer Research Annual Meeting, Califf said he was personally disappointed by the election results but wouldn’t engage in hypotheticals about potential changes to the U.S. Department of Health and Human Services and its agencies, including the FDA, CDC and NIH..

在今天举行的癌症研究之友年会上接受采访时，Califf表示，他个人对选举结果感到失望，但不会对美国卫生与公众服务部及其机构（包括FDA、CDC和NIH）的潜在变化进行假设。。

“From the FDA perspective, we have got all engines on go right now. We’ve done a massive reorganization, we’ve got very significant plans. There’s a meeting going on today that I just left going over hiring. We’re hiring pretty well, not having trouble getting very talented people. I think we just don’t know what’s going to happen now.

“从FDA的角度来看，我们现在所有的引擎都在运行。我们已经进行了大规模的重组，我们有非常重要的计划。今天有一个会议，我刚刚离开了招聘。我们招聘得很好，没有很好的人才。我想我们只是不知道现在会发生什么。

It’s not correct of me to make any specific comments about what exactly will happen, but I do think it’s pretty clear that the gist of this administration from everything that’s been said is to change a lot of things, and how it gets changed depends on who gets appointed to key positions and how the various policies play out — and also, I think as FDA is concerned, how the broader regulated industries see things and play into this.”.

我对确切发生的事情发表任何具体评论都是不正确的，但我确实认为，从所说的一切来看，本届政府的主旨是要改变很多事情，而改变的方式取决于谁被任命为关键职位以及各种政策如何发挥作用，而且，我认为就FDA而言，更广泛的监管行业如何看待事情并在其中发挥作用。”。

“In times of change and chaos, there’s also opportunity,” he continued. “I will just comment, there’s a lot of things that I bet almost everyone in leadership positions in the health agencies would have liked to have changed but couldn’t because of the gridlock of various interests that made it difficult to change things.”.

“在变革和混乱的时代，也有机会，”他继续说道。“我只想评论一下，我敢打赌，几乎所有在卫生机构担任领导职务的人都希望改变很多事情，但由于各种利益的僵局，很难改变。”。

Callif said he believes the FDA is at “peak performance right now — and we’ll see what happens as the new team comes in.”

卡利夫说，他相信美国食品药品监督管理局“目前正处于巅峰状态，我们将拭目以待新团队的到来。”

He defended FDA personnel working on nutrition after attacks by Trump surrogate Robert F. Kennedy Jr.

在特朗普的代理人罗伯特·肯尼迪（RobertF.Kennedy Jr.）袭击后，他为从事营养工作的FDA人员辩护。

“I’ve gotten to know them very well,” Califf said. “They are really hard-working people. And they’re limited in what they can change by the laws that Congress passes.”

“我已经非常了解他们了，”卡里夫说。“他们真的是勤劳的人。国会通过的法律限制了他们可以改变的东西。”

“I want to stand by the people who work at FDA,” he later continued. “They’re good people, they’re hard-working and they want what’s best for the American public. I have no question about that.”

“我想支持FDA的工作人员，”他后来继续说道。“他们是好人，他们工作努力，他们想要的是对美国公众最好的东西。对此我毫不怀疑。”

Asked whether FDA employees are eying the exits, Califf said “people are waiting to see.”

当被问及美国食品和药物管理局（FDA）员工是否在关注出口时，Califf表示“人们正在观望”

“From things that have been said, the change could happen internally or from external decisions made by the administration,” he said. “I just think we have to wait and see and have some faith that hard-working, high-quality people are still going to be in place and have support from — I hope — the external regulated community, which given the dynamics is likely to be the most important factor.

他说：“从已经说过的话来看，变化可能发生在内部，也可能发生在政府做出的外部决定上。”。“我只是认为我们必须拭目以待，并相信勤劳、高素质的人才仍将到位，并得到外部监管机构的支持，鉴于这种动态可能是最重要的因素。

I don’t think there’s a lot the people inside the FDA can say, and what I’ve seen already is they’re putting their heads down and doing the work.”.

我认为FDA内部的人不能说太多，我已经看到他们正在低头做这项工作。”。

While Califf hasn’t officially announced his departure from the FDA, he said today that “this is not the first time I’ve ridden out of town after an election.”

虽然Califf尚未正式宣布退出FDA，但他今天表示，“这不是我在大选后第一次骑马出城。”

Given support from Republicans for his previous confirmations as FDA commissioner, Cardiff offered traits he hopes the agency’s next leader will have: “Executive function, a commitment to using evidence to make decisions and believing there is such a thing as expertise.”

鉴于共和党人对他之前担任FDA专员的确认表示支持，加的夫提出了他希望该机构下一任领导人将具备的特质：“执行职能，致力于利用证据做出决策，并相信存在专业知识。”

“I’m not saying experts are always right,” he said. ” … But not having experts, I think historically in every society, has been a cause for demise of that society.”

他说：“我并不是说专家总是正确的。”…但我认为，从历史上看，每个社会都没有专家，这是该社会消亡的原因。”

He warned that politics and science are not separate, saying that the law allows the president or HHS secretary to make decisions counter to the will of FDA personnel, including its commissioner.

他警告说，政治和科学不是分开的，法律允许总统或卫生和公众服务部部长做出违背FDA人员意愿的决定，包括其专员。

“In more than 99.95% of FDA decisions about individual products, those decisions are made by career civil servants,” he said. “The commissioner actually has no role in that unless there’s an internal dissent and an appeal or in some cases an external appeal that makes it all the way up to the commissioner level.

他说：“在超过99.95%的FDA关于个别产品的决定中，这些决定是由职业公务员做出的。”。“专员实际上在这方面没有任何作用，除非有内部异议和上诉，或者在某些情况下是外部上诉，使其一直上升到专员级别。

But it’s totally within the law for the president or the HHS secretary to overrule the entire FDA. So that could happen. Did it happen to me? No.”.

但是，总统或卫生和公众服务部部长否决整个食品和药物管理局是完全合法的。所以这可能会发生。这发生在我身上了吗？编号”。

“But I also want to say that I think the view that there’s a sharp line between political and scientific, we’ve got to speak truthfully about that,” he continued. “It’s not a sharp line in many cases. I feel like for individual product decisions where you have high quality evidence, where the criteria is survive, feel or function — the standard criteria for medical products — there is no role for politics there.

“但我还想说的是，我认为政治和科学之间存在着尖锐的界限，我们必须诚实地谈论这一点，”他继续说道。“在许多情况下，这并不是一条尖锐的线。我觉得对于个人产品决策，如果你有高质量的证据，标准是生存、感觉或功能-医疗产品的标准-那里没有政治作用。

If a drug enables to live longer and the benefit-risk equation is positive, by law the FDA should approve it. But there are so many aspects of this that are integrated in various ways with politics and there’s just no way around it. … To argue that there’s no integration of politics and science is a mistake, and we’re going to need to talk bluntly about this.”.

如果一种药物能够延长寿命，并且利益-风险方程是积极的，根据法律，FDA应该批准它。但这其中有许多方面与政治以各种方式结合在一起，没有办法避免……认为政治和科学不结合是错误的，我们需要坦率地谈论这一点。”。

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