Dive Brief:

简报：

The Food and Drug Administration has cleared the first medicine under its new National Priority Voucher program, approving a U.S.-manufactured version of a decades-old antibiotic.

美国食品药品监督管理局根据其新的国家优先凭证计划批准了首款药物，这是一种在美国制造的、已有数十年历史的抗生素。

GSK originally developed the drug, Augmentin XR, and

GSK 最初开发了这种药物，Augmentin XR，而且

won FDA approval

获得了FDA的批准

for it in 2002. The British company then

因为它在2002年。然后这家英国公司

struck a deal

达成了协议

in 2010 to sell its U.S. penicillin business, including its Augmentin franchise, to the generic drugmaker Dr. Reddy’s Laboratories. A Bristol, Tennessee, plant that was part of that deal is now operated by

2010年，该公司将其美国青霉素业务，包括其奥格门汀特许经营权，出售给了仿制药制造商Dr. Reddy’s Laboratories。作为该交易的一部分，位于田纳西州布里斯托尔的一家工厂现在由

USAntibiotics

美国抗生素

, which won the priority voucher.

，赢得了优先券。

FDA Commissioner Martin Makary trumpeted the approval as a boon for crucial supply chains of medications that often

FDA专员马丁·马卡里宣布这项批准对常常关键的药物供应链是一大福音

end up in shortages

最终导致短缺

. The move “will strengthen domestic manufacturing and increase our national security,” Makary said in a

“此举将‘加强国内制造业并增强我们的国家安全’，马卡里在一份声明中说道。

statement

声明

Tuesday.

星期二。

Dive Insight:

深度洞察：

The Trump administration forged the

特朗普政府达成了

National Priority Voucher

国家优先凭证

system for medicines that address U.S. “national interests,” promising it would allow the FDA to evaluate new therapies in as little as one to two months, instead of the usual 10 months under the Prescription Drug User Fee Act.

针对符合美国“国家利益”的药品的系统，承诺将使FDA能够在短短一到两个月内评估新疗法，而不是根据《处方药使用者费用法案》通常所需的10个月。

The idea has

这个想法已经

drawn controversy

引发争议

, with

，与

Congressional Democrats

国会民主党人

arguing it has the potential to create “a new, lucrative gift for drugmakers and allies politically favored by President Trump.” Concerns about the initiative

认为此举有潜力创造“一个对特朗普总统政治上青睐的制药商及其盟友来说新的、丰厚的礼物。” 对此倡议的担忧

reportedly factored into the decision

据报道，这是决策的一个因素。

by Richard Pazdur, the FDA’s top drug reviewer, to

由 FDA 首席药物评审员 Richard Pazdur

retire from the agency

从机构退休

just weeks after taking the job.

就在接手这份工作几周后。

FDA officials issued the

FDA官员发布了

first round of vouchers

第一轮代金券

in October to nine drugmakers, including USAntibiotics. The company is the only U.S. producer of amoxicillin and Augmentin and, like other manufacturers, has

10月，美国抗生素公司等九家制药商收到了通知。该公司是美国唯一的阿莫西林和奥格门汀生产商，和其他制造商一样，具有相同的情况。

struggled in a market

在市场中挣扎

that desperately needs a steady supply of generic antibiotics yet pays very little for them.

急需稳定供应的通用抗生素，但对其支付的费用却很少。

In its

在其

press release

新闻稿

touting the voucher win in October, USAntibiotics offered a dire warning. “If our doors close, it would take half a decade and hundreds of millions of dollars to rebuild this capability,” Patrick Cashman, the company’s president, said in the statement. “That’s five years in which America would be completely reliant on adversarial nations for the most prescribed antibiotic in the country.”.

今年10月，美国抗生素公司在宣传其代金券的胜利时，发出了一个严峻的警告。该公司总裁帕特里克·卡什曼在声明中表示：“如果我们的大门关闭，那么重建这一能力将需要花费五年的时间和数亿美元的资金。这意味着美国在五年内将完全依赖敌对国家来获取该国最常用的抗生素。”

USAntibiotics

美国抗生素

rescued

救援

the Bristol facility in 2021 after it had been owned by

2021年布里斯托尔工厂在被

Neopharma

新药

, which took it over from Dr. Reddy’s. As of 2024, Augmentin XR was listed on the FDA’s discontinued drug products list, but the agency that year cleared the way for another approval by

，该药物从Dr. Reddy's接手而来。截至2024年，Augmentin XR被列入FDA的停产药品清单，但该机构同年为另一种批准扫清了道路。

making note

做笔记

that the medicine wasn’t withdrawn because of concerns about safety or effectiveness.

这种药并没有因为安全或有效性问题而被撤回。

The FDA issued a

FDA发布了

second round of vouchers

第二轮代金券

last month, a list that included two weight loss drugs. Novo Nordisk is using its voucher to seek approval of a higher-dose version of

上个月，一张包含两种减肥药的名单。诺和诺德正在使用其券来寻求更高剂量版本的批准。

Wegovy

韦哥维

, while Lilly is advancing an experimental pill called orforglipron. The vouchers were part of a

，而礼来公司正在推进一种名为orforglipron的实验性药物。这些券是其中的一部分

larger deal

更大的交易

on obesity drug pricing with the White House.

与白宫就肥胖药物定价问题。