Dive Brief:

摘要：

The Food and Drug Administration should look for ways to streamline regulations on new U.S. drug manufacturing facilities to speed their completion and boost domestic supply, under an executive order

根据一项行政命令，美国食品药品监督管理局应该寻找简化美国新药生产设施监管规定的方法，以加快其完工并增加国内供应。

signed Monday

周一签署

by President Donald Trump.

由唐纳德·特朗普总统。

The order also seeks to increase inspections of overseas manufacturing plants supplying the U.S. market funded by increased fees “to the extent consistent with applicable law.” The FDA will disclose the annual number of overseas inspections by country and by manufacturer.

该命令还寻求增加对供应美国市场的海外生产工厂的检查，资金来源是提高收费，“在符合适用法律的范围内”。美国食品和药物管理局将按国家和制造商披露每年在海外进行检查的次数。

Big pharma companies this year have announced investment of more than

大型制药公司今年已宣布投资超过

$170 billion in new manufacturing facilities

1700亿美元的新制造设施

in the U.S. as they seek to consolidate their supply chains and avoid potential new tariffs. Public comments are due Wednesday on a

在美国，他们试图巩固自己的供应链，避免潜在的新关税。公众意见将于周三截止。

Commerce Department investigation

商务部调查

on the national security risks of drug and ingredient imports, which could set the stage for new sector-wide tariffs.

关于药物和成分进口对国家安全的风险，这可能为新的全行业关税奠定基础。

Dive Insight:

深入洞察：

The pharmaceutical industry finds itself pressured by the Trump administration along three different channels: taxes, trade and drug pricing. Company executives have credited the Tax Cut and Jobs Act — passed in 2017 during Trump’s first administration and due to expire later this year — for sparking investment in domestic manufacturing, including the billions of dollars announced so far in 2025..

制药行业发现自己在三个不同方面受到特朗普政府的压力：税收、贸易和药品定价。公司高管们认为，《减税与就业法案》——于2017年在特朗普第一届政府期间通过，并将于今年晚些时候到期——推动了国内制造业的投资，包括目前已宣布的数十亿美元投资计划在2025年实施。

Meanwhile, the threat of tariffs to drugs and ingredients manufactured overseas poses a risk to their profit outlook, one that can’t be easily resolved by raising prices established through negotiations with insurers. Finally, the White House is looking at ways to restrain drug prices that could go beyond what was enacted in the Inflation Reduction Act..

同时，对海外生产的药品和成分征收关税的威胁对其利润前景构成了风险，这一风险无法通过提高与保险公司谈判确定的价格轻松解决。最后，白宫正在寻找限制药品价格的方法，这些方法可能超出《通胀削减法案》中所规定的范围。

Alongside Monday’s executive order, Trump said an announcement on tariffs and drug pricing rules could come in the next two weeks.

特朗普表示，除了周一的行政命令外，有关关税和药品定价规则的公告可能会在未来两周内发布。

The push from Johnson & Johnson, Eli Lilly, Merck & Co., Novartis and Roche is one part an effort to reshore the U.S. drug supply chain and one part public relations trying to persuade Trump to reverse course on any plans to set new tariffs or new drug price controls.

强生、礼来、默克、诺华和罗氏的推动一方面是为了重塑美国药品供应链，另一方面则是公关努力，试图说服特朗普放弃任何设定新关税或新药价控制的计划。

Building new drug factories takes time — the executive order claims it now takes five to 10 years — which means the billions of dollars spent on new manufacturing capacity this year will have a negligible effect on securing the supply chain. To get them built faster, the executive order instructs FDA to reduce “duplicative or unnecessary requirements” review steps and maximize “timeliness and predictability.”.

建造新的药物工厂需要时间——行政命令声称现在需要五到十年——这意味着今年花费在新生产能力上的数十亿美元对确保供应链的安全影响甚微。为了加快它们的建设速度，行政命令指示FDA减少“重复或不必要的要求”审查步骤，并最大限度地提高“及时性和可预测性”。

On licensure inspections, the order tells FDA to “ensure all required inspections are prompt, efficient, and limited to what is necessary to ensure compliance,” as well as evaluate whether all scheduled inspections are necessary. Meanwhile, the new inspection requirements on overseas plans supplying the U.S.

在许可检查方面，该命令要求 FDA“确保所有必要的检查都及时、高效，并且仅限于确保合规性所必需的范围”，同时评估是否所有计划中的检查都是必要的。与此同时，针对向美国供应产品的海外计划，提出了新的检查要求。

could provide a further incentive to move production stateside..

可能为进一步将生产转移至美国提供激励。

Alex Schriver, senior vice president of public affairs at the industry lobbying group the Pharmaceutical Research and Manufacturers of America said in a statement that the order was a “welcome step toward supporting the hundreds of billions of dollars in new U.S. investments.”

美国制药研究与制造商协会行业游说团体的公共事务高级副总裁亚历克斯·施里弗在一份声明中表示，该命令是“支持数千亿美元美国新投资的可喜一步”。

But he added, “Imposing tariffs on medicines or adopting foreign price setting policies would result in less U.S. investment and weaken U.S. leadership at a time when we are facing growing competition from China.”

但他补充说：“对药品征收关税或采取外国价格设定政策，会导致美国投资减少，并削弱美国在我们面临来自中国日益激烈的竞争时的领导地位。”