The Trump administration is considering putting “severe restrictions” on the increasing flow of investigational drugs from China, according to reporting by The New York Times.
A draft executive order is being circulated to Big Pharmas, billionaire stakeholders and biotech VC investors that accuses China “and other hostile actors” of having “exploited gaps in our open scientific and regulatory systems,” the NYT reported Sept. 10.
The draft order includes a suggested policy that would see heavier scrutiny on U.S. pharmas’ attempts to license drugs from Chinese biotechs, including ensuring that these licensing deals are assessed by a U.S. national security committee, according to the NYT.
These sorts of deals have become an increasingly regular occurrence, with recent months alone seeing Pfizer pay China’s 3SBio $1.25 billion upfront for a PD-1xVEGF bispecific, while AstraZeneca handed over $110 million to existing Chinese partner CSPC Pharmaceutical to collaborate on chronic disease drugs.
Another proposed policy referenced in the NYT’s reporting would require a more rigorous review of Chinese clinical trial data by the FDA, along with higher regulatory fees for companies that submit China trial data.
Meanwhile, the document also calls for boosting U.S. production of medicines like antibiotics and the pain relief drug acetaminophen, with products produced stateside given preference by the government for purchasing, the NYT said.
According to the NYT, the White House pushed back on the reporting and said it is not “actively considering” the draft order.
In the same article, the NYT referred to discussions in the Trump administration about looking to speed up the FDA review process to allow drugmakers to launch clinical studies sooner. The suggestion mirrors a push at China’s medicines regulator to find ways to speed up its own review process.
The various proposals reported by the NYT are being backed by billionaires and other investors with significant stakes in the U.S. biotech sector who are concerned about the rise of China’s influence, according to the newspaper.
China has been cementing its newfound position as a major source of medicine innovation in recent years. In the first three months of 2025, 32% of outlicensing biotech deal value occurred in China, versus 21% reported in both 2024 and 2023, according to a Jefferies equity research report published in July.
At the time, analysts at Jefferies described how “China biotechs are reshaping the U.S. biopharma landscape, as in-licensing assets from China could offer multinational corporations a remedy to alleviate pressure affordably and within a manageable time frame.”
In June, PwC analysts were offering a warning that the speedy evolution of the Chinese biotech sector was creating “heightened risks related to IP security, regulatory compliance and strategic alignment.”
These issues have been on the radar of the Trump administration for some time. In February, the administration issued a memorandum titled the “America First Investment Policy” for several federal leaders. Emphasizing national and economic security, the policy aimed to restrict both inbound and outbound investments related to “foreign adversaries” in certain strategic industries.
The document put China front and center and mentioned both healthcare and biotech among the sectors it would regulate.
https://www.fiercepharma.com/biotech/trump-admin-mulls-severe-restrictions-us-pharmas-securing-chinese-meds-nyt
