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FDA Commissioner Marty McCurry warned that the United States was lagging behind China in the early stages of drug development, and called for reforms that could simplify the process of starting trials on new treatments.
In an interview with CNBC on Wednesday, McCurry specifically pointed to three bottlenecks that he said caused the United States to fall behind in those early drug trials.
This includes contracting with hospitals, as well as ethical reviews and approvals, both of which he described as “complicated processes that take a long time and make us unable to compete with countries that move much faster.” He also pointed to the process of submitting and receiving approvals for so-called investigational new drug applications, which companies submit to test a product in humans.
“We’re in chaos,” McCurry said, referring to how far behind China the United States is in phase 1 clinical trials scheduled for 2024.
Food and Drug Administration (FDA) Commissioner Marty McCurry speaks in the Oval Office of the White House on January 29, 2026 in Washington, DC.
Samuel Corum | Getty Images
The FDA is “looking at everything,” he said, such as whether it can partner with health systems and academic medical centers in the pre-IND process. This refers to the time when companies consult with the Food and Drug Administration (FDA) before officially submitting an application.
He added that the Trump administration should “partner with industry to help them provide more beneficial treatments and cures to the American people because this is a bipartisan goal that we all want.” “And we will get it done in this administration.”
China’s biotech ecosystem has boomed over the past several years, driven by massive state investment, a massive talent pool and accelerating regulatory reforms. China, once known as a low-cost manufacturing base churning out imitators, is rapidly developing into a global powerhouse of innovation.
Data from GlobalData and Morgan Stanley show that China now conducts more clinical trials than the United States, accounts for nearly a third of global new drug approvals, and is on track to reach 35% of FDA approvals by 2040.
US policymakers are under pressure to take steps to boost innovation domestically.
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