
一粒过敏药上的红色斑点可能是美国患者与潜在致命药物反应之间唯一的屏障。7月,由于在印度制造过程中被另一种药物污染,西替利嗪(即Zyrtec的仿制药)的若干批次被召回。污染在工厂未被发现。FDA进口筛查也未发现。正是因为一名药房技术员恰好注意到有东西看起来不对劲,才被发现。目前的系统未能充分保障药品纯度和安全,这令人担忧。
A red speck on an allergy pill may have been the only thing standing between American patients and potentially deadly medication reactions. In July, batches of cetirizine, the generic version of Zyrtec, were recalled after being contaminated with another drug during manufacturing in India. The contamination was not caught at the factory. It was not caught by FDA import screening. It was caught because a pharmacy technician happened to notice something looked wrong. It is alarming that systems currently in place were not adequate to ensure drug purity and safety.
在成为国会议员之前,我作为医生工作了30多年,无数次开具过Zyrtec等药物的处方。父母带着患有季节性过敏、哮喘、湿疹及其他疾病的孩子来到我的诊室,我开具这些处方时,从未怀疑患者是否能相信瓶子里的药物正是标签上所写的那样。如今,这种信任越来越依赖于数千英里之外、隔着海洋的工厂。美国已将更多药品供应链转移海外,使我们高度依赖中国和印度等国家。
Before I became a member of Congress, I worked for more than 30 years as a physician, and I prescribed medications like Zyrtec countless times. Parents brought their children into my office with seasonal allergies, asthma, eczema, and other conditions, and I wrote those prescriptions without wondering whether patients could trust that the medicine inside the bottle was exactly what the label said it was. Today, that trust is increasingly dependent on factories thousands of miles and an ocean away. America has pushed more of its pharmaceutical supply chain overseas, leaving us heavily dependent on countries like China and India.
用于生产基本药物的成分中,超过80%是在海外生产的,其中用于生产关键药物(如青霉素和阿莫西林等抗生素)的原材料有90%来自海外。中国主导着这些原材料的生产,而印度则利用中国的输入来生产仿制药。我们是否能信任这一供应链,存在严重问题。美国药品制造商面临严格且无预告的FDA检查。尽管外国设施供应了美国人依赖的大部分药物,但它们历来会提前收到通知,且检查频率较低。即使有这种预警,外国工厂因严重质量问题被指出的比率仍显著高于美国工厂。
More than 80 percent of the ingredients used to make essential medicines are produced overseas, including 90 percent of the raw materials used to produce critical drugs, like the antibiotics penicillin and amoxicillin. China dominates the production of many of those raw materials, while India uses Chinese inputs to manufacture generic medicine. There are serious questions about whether we can trust this supply chain. American drug manufacturers face strict, unannounced FDA inspections. Foreign facilities have historically received advance notice and are inspected less frequently, despite supplying a large share of the medicines Americans rely on. Even with that warning, foreign plants are still cited for serious quality problems at significantly higher rates than American facilities.
当我们的孩子服用的药物、住院患者依赖的抗生素以及数百万美国人用于管理慢性病的药物是在国外生产时,我们面临的不再仅仅是一个医疗保健问题。我们面临着国家安全漏洞。我们应该担心任何外国国家都可能对美国人民的健康和安全拥有这种杠杆作用。更不用说像共产主义中国这样的对手了。对手甚至不需要开一枪就能伤害数百万美国人。
When the medicine our children take, the antibiotics hospitalized patients depend on, and the drugs that millions of Americans use to manage chronic conditions are manufactured abroad, we no longer have just a health care issue. We have a national security vulnerability. We should be concerned that any foreign nation should have that kind of leverage over the health and safety of the American people. Much more so an adversary like Communist China. An adversary would not need to fire a single shot to harm millions of Americans.
它只需切断我们的救命药物供应,或在药物到达我们海岸之前对其进行污染。美国人有权知道他们的健康和安全有多少掌握在他人之手。这就是为什么我和我的同事一直在与特朗普总统合作,采取重要步骤来应对这一漏洞。在国内生产更多药物不仅能加强我们的药品供应链,还能创造美国就业岗位,改善监督,并确保患者能够安全、可靠地获得他们所依赖的药物。
It could simply cut off our supply of life-saving medicines or contaminate them before reaching our shores. Americans deserve to know just how much of their health and safety rests in the hands of other countries. That is why my colleagues and I have been working with President Trump to take important steps to confront this vulnerability. Making more medicine here at home would not only strengthen our pharmaceutical supply chain but create American jobs, improve oversight, and ensure patients have safe, reliable access to the medicines they depend on.
特朗普政府已终止对海外FDA检查的提前通知,这有助于确保外国制药厂遵守与国内制造商相同的严格标准。特朗普总统签署了行政命令《促进关键药物国内生产的监管减负》,指示FDA改进其基于风险的检查模式,加强对外国制药设施的监督,并消除阻碍本国生产关键药物的不必要的障碍。然而,仅加强对进口药物的监督只是解决方案的一部分。
The Trump administration has put an end to advance notice for overseas FDA inspections, helping ensure that foreign pharmaceutical plants are held to the same rigorous standards as manufacturers here at home. President Trump signed the executive order, “Regulatory Relief to Promote Domestic Production of Critical Medicines,” directing the FDA to improve its risk-based inspection models, strengthen oversight of foreign pharmaceutical facilities, and remove unnecessary barriers standing in the way of producing critical medicine in this country. However, strengthening oversight of the drugs we import is only part of the solution.
我们还需要重建在美国本土生产关键药物的能力,我很自豪密苏里州是这一解决方案的一部分。马里兰高地的Sentio BioSciences公司已与St.路易斯API创新中心获得了1400万美元的《国防生产法》奖项,以帮助重建我们国家的国内药品制造能力。Sentio BioSciences正致力于在美国境内利用国内供应链生产关键药物成分。
We also need to rebuild our capacity to manufacture critical medicines here in the U.S., and I am proud that Missouri is part of the solution. Sentio BioSciences, based in Maryland Heights, has partnered with the St. Louis API Innovation Center, which received a $14 million Defense Production Act award, to help rebuild our nation’s domestic drug manufacturing capacity. Sentio BioSciences is working to produce key drug ingredients here in the United States using domestic supply chains.
通过先进技术,该公司找到了一种以可负担成本制造这些成分的方法,同时保持在需要时快速转换生产以应对全国性药物短缺的灵活性。将该生产转回美国,尤其是密苏里州,将使创新者能够帮助保障我们的药品供应,保护患者,并恢复我们国家本不该放弃的国内制造能力。美国人不应依赖外国来获取他们所依赖的药物。
Through advanced technology, the company has found a way to manufacture those ingredients affordably while maintaining the flexibility to quickly shift production when needed to respond to national drug shortages. Bringing that production back to the United States, and especially to Missouri, will allow innovators to help secure our drug supply, protect patients, and restore the domestic manufacturing capacity our country should never have surrendered. Americans should not be at the mercy of foreign countries for the medicines they rely on.
我们应该在国内生产更多,在那里我们可以监督其生产过程并让制造商承担责任。归根结底,每个美国人都应该能够打开他们的药柜,相信里面的药物是安全的。鲍勃·安德尔代表密苏里州第3选区进入国会。他是GOP医生党团的成员。
We should be making more here at home, where we can oversee how they are made and hold manufacturers accountable. At the end of the day, every American should be able to open their medicine cabinet and trust that what is inside is safe. Bob Onder represents Missouri’s 3rd District in Congress. He is a member of the GOP Doctors Caucus.