【By Observer News, Zhang Jingjuan】While the United States is still struggling to cope with the aftereffects of industrial hollowing out, another more subtle industry loss has quietly occurred.

Jacob Becraft, co-founder and CEO of American biotechnology company Strand Therapeutics, wrote in an article published on The Washington Post on the 6th that at the end of the last century, the United States outsourced manufacturing to countries with lower labor costs such as China, trying to enjoy the benefits of cheap goods while maintaining its innovation leadership at home. However, behind the short-term economic gains are irreversible long-term losses: domestic industrial hollowing out, a significant weakening of supply chain resilience, the loss of millions of jobs, and the rise of foreign competitors, which have now been able to compete with the United States in many industries, even surpassing it.

"Now, the United States is repeating the same mistake in the biotechnology sector," wrote Becraft. Increasingly, American biopharmaceutical companies are choosing to move their clinical trials to China, where they see high efficiency and low cost in early medical research.

Data shows that between 2010 and 2021, the number of clinical trials conducted by Western companies in China more than doubled, reaching about 50% more in 2023 than in the United States.

Among the voices supporting this trend, the most common argument is: as long as Americans can eventually access new drugs, it doesn't matter where the drug was initially tested.

However, for Becraft, who has worked in gene medicine for more than ten years, this view has serious flaws. He believes that early-stage clinical development is not a replaceable low-value part, and where the trial is conducted determines where expertise is accumulated, where data is generated, and where the next generation of therapies is nurtured. "Handing over this innovative phase to China will threaten America's scientific strength and national security."

Becraft said that outsourcing early innovation is not inevitable. With a targeted adjustment to clinical trial approval policies, the United States can reverse this trend, making new drugs cheaper and more accessible to American people.

In early drug development, speed and cost are crucial. The earlier companies start trials, the faster they can verify whether their scientific ideas are valid. These key milestones attract investors and partners, leading to more investment for early innovators, ultimately offering patients more treatment options.

Clinical trial center staff use a centrifuge to separate blood. IC photo

China has recognized this and taken decisive action. The direct cost of trials in China can be as much as 30% lower than in the United States, patient recruitment is faster, and logistics processes are simpler. All of this is made possible by a decentralized trial approval mechanism.

Notably, China has continuously optimized its clinical trial review and approval mechanism, significantly reducing the related review and approval time. The China National Medical Products Administration previously stated that the average time for reviewing clinical trials of innovative drugs has been reduced from 175 working days in 2017 to 50 working days in 2024.

The article mentions that China has delegated trial approval authority to local ethics review committees at each hospital, greatly shortening the time and effort required to start early clinical trials. Similarly, Australia also uses a similar model, where local ethics committees approve first-in-human trials, while maintaining strict supervision. This model did not affect safety, because no one has more incentive than the hospital's own review committee to ensure patient safety. As a result, China and Australia have become popular destinations for early clinical trials.

However, in the United States, regardless of the stage or scale of the clinical trial, it must go through FDA review before it starts. There is no denying that for later trials aimed at final approval, strict regulation is essential. However, for small first-in-human trials involving only dozens of patients with no other treatment options, this review has become a bottleneck, not only increasing R&D costs but also hindering the innovation process. This delay in approval misleads the entire R&D process, leading to high drug prices and lengthy R&D cycles.

Becraft warned that outsourcing clinical trials may seem harmless at first glance, but it could lead to a dangerous cycle similar to what happened in manufacturing. As early trials move overseas, biotechnology infrastructure will follow. Overseas trial institutions accumulate experience in conducting cutting-edge research, and the local industries formed around them grow rapidly with speed and iteration as their advantages.

At the same time, the number of U.S. domestic trial institutions is decreasing, and they are constrained by complex regulations and long startup cycles. "U.S. companies face a dilemma: either conduct slow and expensive trials domestically; or send trials abroad, helping foreign innovation ecosystems grow into direct competitors, thereby eroding the United States' leading position in biopharmaceutical innovation."

In Becraft's view, the impact of this outsourcing goes beyond the economic level. Giving up early clinical capabilities weakens the United States' ability to protect public health and maintain strategic autonomy, and in the future, it could even make American citizens' lives and health dependent on foreign governments.

Nevertheless, he believes this bleak outlook is not irreversible. The United States can transfer the approval authority for first-in-human trials from the FDA to institutional review boards, making it feasible again to conduct early trials domestically. This reform can also improve the unfairness of trial participation. Currently, many Americans live several hours away from hospitals conducting clinical trials. Allowing regional medical centers to conduct trials can expand accessibility and reduce costs for sponsors, accelerating the R&D process.

Additionally, simplifying such approvals would reshape investor incentives. Lower costs and predictable timelines can reduce resistance to testing new ideas, attracting more capital to U.S. early innovators. At the same time, hospitals and regional medical centers would have the motivation to invest in personnel and facilities needed for trials, expanding trial capacity nationwide.

"Australia is just like that: once the approval cycle becomes predictable, private capital floods in, supporting facilities expand, and early trials surge." Becraft believes that keeping first-in-human trials in the United States is an economic necessity. The U.S. currently holds about half of the global pharmaceutical market. If R&D and early development stages continue to flow overseas, the U.S. will face long-term massive trade imbalances: foreign countries develop drugs, and the U.S. pays for them.

The article concludes by stating that after paying a heavy price, the U.S. has realized that outsourcing manufacturing brings short-term savings but leads to long-term losses. The biotechnology sector is no different. If early trials continue to leave the U.S., Americans will pay the price for decades to come.

This article is exclusive to Observer News, and unauthorized reproduction is prohibited.

Original: toutiao.com/article/7614419844645962250/

Statement: The article represents the views of the author.