FDA 法规75%-80%将会被废除

Trump to Pharma CEOs: 75% to 80% of FDA Regulations Will be Eliminated

唐纳德∙特朗普总统周二告诉制药公司的CEO们，他的管理团队会以前所未有的方式裁撤制药行业的法规，这也预示着美国FDA(食品药品管理局)将要发生的事情。

In a sign of what’s to come for the US Food and Drug Administration (FDA), President Donald Trump told pharmaceutical company CEOs Tuesday that his administration will be “cutting regulations at a level no one has ever seen before.”

特朗普与美国药物研发与生产组织（PhRMA）、 Merck、Novartis、Johnson & Johnson, Celgene及其他公司的CEO举行了会面，而在此之前特朗普评论说，我们将优化药品的审批程序，简化流程，当我们有一个新药的时候，我们需要尽快的批准，而不是一等再等好多年。

The comments, which came before the meeting with CEOs from industry group PhRMA ( Pharmaceutical Research and Manufacturers of America), Merck, Novartis, Johnson & Johnson, Celgene and others, Trump said in terms of the drug approval process: “We’re also going to be streamlining the process, so that from your standpoint, when you have a drug you can actually get it approved, instead of waiting for many, many years."

同时他要求大幅降低药品价格，要求联邦医疗保险就药品价格与制药公司要有更好的谈判。

He also called for significantly lower drug prices and again for better negotiations on drug prices between Medicare and companies.

FDA法规裁减

特朗普说，关于FDA的规则、指导意见、法规等，有可能不是现在的9000页，而应当是100页。同时特朗普补充说道，大概75%-80%的FDA法规会被裁撤。

“Instead of it being 9,000 pages, it’ll be 100 pages,” Trump said, perhaps in reference to FDA’s rulemakings, guidance and other regulations.  Between 75% and 80% of all FDA regulations will be eliminated, he added,

但是如其他人所注意到的，不管药物在哪里生产，这些制药公司必须符合美国的法律法规，从而可以进入美国市场，因为这是全世界最大的药品市场。

But as others have noted, no matter where a drug is manufactured, companies have to follow US laws and regulations in order for that drug to enter the US market, which is still the biggest market for pharmaceuticals in the world.

关于FDA 长官的人选，特朗普说很快就会宣布。

As far as his choice for FDA commissioner, Trump said an announcement is coming soon. 

美国药物研发与生产组织 CEO Stephen Ubl对此次会议的评价是非常积极的也是非常有建设性的，同时也说，特朗普政府对于税收、贸易及法规层面的变革会在生物制药领域未来10年里增加35万个工作岗位。

PhRMA CEO Stephen Ubl called the meeting positive and productive and said Trump's agenda on taxes, trade and regulation could create 350,000 US jobs over 10 years for the biopharmaceutical industry.

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RAPS: The Regulatory Affairs Professionals Society