特朗普：FDA法規80%將會(huì )被廢除

唐納德．特朗普總統周二告訴制藥公司的CEO們，他的管理團隊會(huì )以前所未有的方式裁撤制藥行業(yè)的法規，這也預示著(zhù)美國FDA(食品藥品管理局)將要發(fā)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.”

特朗普與美國藥物研發(fā)與生產(chǎn)組織(PhRMA)、 Merck、Novartis、Johnson & Johnson, Celgene及其他公司的CEO舉行了會(huì )面，而在此之前特朗普評論說(shuō)，我們將優(yōu)化藥品的審批程序，簡(jiǎn)化流程，當我們有一個(gè)新藥的時(shí)候，我們需要盡快的批準，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."

同時(shí)他要求大幅降低藥品價(jià)格，要求聯(lián)邦醫療保險就藥品價(jià)格與制藥公司要有更好的談判。

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

FDA法規裁減

特朗普說(shuō)，關(guān)于FDA的規則、指導意見(jiàn)、法規等，有可能不是現在的9000頁(yè)，而應當是100頁(yè)。同時(shí)特朗普補充說(shuō)道，大概75%-80%的FDA法規會(huì )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，不管藥物在哪里生產(chǎn)，這些制藥公司必須符合美國的法律法規，從而可以進(jìn)入美國市場(chǎng)，因為這是全世界最大的藥品市場(chǎng)。

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.

關(guān)于FDA 長(cháng)官的人選，特朗普說(shuō)很快就會(huì )宣布。

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

美國藥物研發(fā)與生產(chǎn)組織 CEO Stephen Ubl對此次會(huì )議的評價(jià)是非常積極的也是非常有建設性的，同時(shí)也說(shuō)，特朗普政府對于稅收、貿易及法規層面的變革會(huì )在生物制藥領(lǐng)域未來(lái)10年里增加35萬(wàn)個(gè)工作崗位。

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.