经济学家托马斯·菲利普森警告：中国更快的临床试验体系可能会将投资从美国引走
2026年6月1日 美国东部时间早上8:00 / 福克斯新闻
作者：阿曼达·马西亚斯
“繁荣解放”智库经济学家托马斯·菲利普森认为，FDA漫长的审批流程正在延误救命疗法的上市，并呼吁效仿新冠疫情时期的“曲速行动”模式，加快患者获取新药的速度。
NEW 您现在可以收听福克斯新闻的文章了！
一份新报告指出，加快美国食品药品监督管理局的审评速度，能够解锁数万亿美元的经济价值，并更快地将救命疗法送到患者手中。
“一款新药从研发到最终通过FDA审批，全程大约需要十年时间，”曾任白宫经济顾问委员会代理主席的经济学家托马斯·菲利普森在接受福克斯新闻数字频道采访时表示，“其中大部分时间并没有花在安全性验证上，绝大多数时间都耗费在有效性试验上。”
这份题为《改革FDA的数万亿美元机遇》的报告估算，如果将FDA的有效性审评时长缩短一年，就能通过更早地将新疗法推向患者、激励更多医疗创新，创造超过10万亿美元的经济价值。
据Goodrx统计，2024年有19款药物展现“重大临床影响”
报告认为，加快药物审批速度能够通过提升制药厂商间的竞争，帮助降低处方药成本。(iStock)
菲利普森指出，药物审批流程中的大部分延误，都源于有效性验证环节，而非安全性测试。
“国会赋予FDA的职责是保障新药的安全性和有效性，”菲利普森表示，“民众认可政府在保障安全和消费者保护方面的作用，但FDA肩负的验证药品有效性的职责是独一无二的。”
他还认为，加快审批速度能够通过增加制药厂商间的竞争，帮助降低处方药成本。
“改革FDA将对患者的药物可负担性产生巨大影响，因为这将让更多药物更快上市，大幅提升行业竞争程度，”他说。
“曲速行动”堪称奇迹，特朗普政府不应放弃造就这一成果的技术
报告还对联邦政府是否应该继续在药品上市前验证其有效性方面扮演如此重要的角色提出了质疑。(伊萨姆·艾哈迈德/法新社)
报告估算，如果将审批速度加快1至6年，就能通过让患者更早用上药物、生物制剂和医疗器械，以及强化创新激励，创造数万亿美元的经济价值。
报告作者同时警告，中国更快、成本更低的临床试验体系，可能会将药物研发投资和相关活动从美国引走。
菲利普森表示，来自中国的竞争压力凸显了政策制定者重新审视FDA审批节奏的必要性。
点击此处下载福克斯新闻APP
报告作者提出了多项改革建议，包括在药物审评中更多地应用人工智能。(iStock)
“我认为总统可以发挥巨大作用，推动一场类似新冠疫情期间曲速行动的努力，”菲利普森说，“对于那些没有感染新冠，但患有其他疾病的患者群体来说，这同样刻不容缓。”
报告作者提出的改革方案包括：在药物审评中更多地应用人工智能、加快临床试验设计速度，以及扩大“尝试权”项目的覆盖范围。
阿曼达负责为福克斯新闻数字频道报道商业与政治的交叉领域。
https://www.foxnews.com/video/6397215771112
FDA delays cost Americans trillions and slow lifesaving drugs, new report says
Economist Tomas Philipson warns China’s faster clinical trial system could lure investment away from the US
June 1, 2026 8:00am EDT / Fox News
By Amanda Macias
Unleash Prosperity economist Tomas Philipson argues lengthy FDA approval timelines are delaying lifesaving treatments and calls for a COVID-era “Operation Warp Speed” model to accelerate patient access to new medicines.
NEW You can now listen to Fox News articles!
A new report argues that speeding up Food and Drug Administration reviews could unlock trillions of dollars in economic value and get lifesaving treatments to patients faster.
“It takes about a decade from start to finish to come through FDA,” economist and former acting chairman of the White House Council of Economic Advisers Tomas Philipson told Fox News Digital in an interview. “Most of that time is not spent on safety. Most of it time is spent on effectiveness trials.”
The paper, titled “The Multi-Trillion Dollar Opportunity in Reforming the FDA,” estimates that cutting FDA effectiveness-review timelines by one year could generate more than $10 trillion in economic value by getting new treatments to patients sooner and encouraging additional medical innovation.
19 DRUG APPROVALS IN 2024 THAT HAD ‘BIG CLINICAL IMPACT,’ ACCORDING TO GOODRX
The report argues that speeding up drug approvals could help reduce prescription costs by boosting competition among manufacturers.(iStock)
Philipson argued that most delays in the drug approval process stem from determining effectiveness rather than safety.
“FDA is charged by Congress to enhance both safety and effectiveness of new drugs,” Philipson said. “People recognize the role of the government potentially ensuring safety and consumer protection, but it’s a unique role that FDA has of ensuring effectiveness.”
He also argued that faster approvals could help lower prescription drug costs by increasing competition among manufacturers.
“Reforming FDA would have a big impact on drug affordability for patients because it would allow for far more competition between drugs that come out faster,” he said.
OPERATION WARP SPEED WAS MIRACULOUS. TRUMP ADMIN SHOULD NOT ABANDON TECHNOLOGY THAT MADE IT POSSIBLE
The report also questions whether the federal government should continue playing such a large role in determining a drug’s effectiveness before it reaches the market.(Issam Ahmed/AFP)
The report estimates that accelerating approvals by one to six years could generate trillions in economic value through earlier access to drugs, biologics and medical devices, as well as stronger incentives for innovation.
The authors also warn that China’s faster, lower-cost clinical trial system could lure investment and drug development activity away from the United States.
Philipson said the competitive challenge from China underscores the need for policymakers to rethink the pace of FDA approvals.
CLICK HERE TO DOWNLOAD THE FOX NEWS APP
The authors propose reforms including greater use of artificial intelligence in drug reviews.(iStock)
“I think there’s a huge role for the president here to push an analogous effort to what he did with Operation Warp Speed during COVID,” Philipson said. “It’s equally urgent for other patient groups who don’t have COVID but other diseases.”
The authors propose reforms including greater use of artificial intelligence in drug reviews, faster clinical trial designs and broader access to “right to try” programs.
Amanda covers the intersection of business and politics for Fox News Digital.
https://www.foxnews.com/video/6397215771112
发表回复