FDA chief warns US is losing ground to China in early drug trials
Food and Drug Administration Commissioner Marty Makary warned that the U.S. is falling behind China in early drug development and called for reforms that could streamline the process for starting trials of new treatments.
In an interview with CNBC on Wednesday, Makary pointed to three bottlenecks in particular that he said are causing the U.S. to fall behind in these early drug trials.
These include hospital contracts and ethical reviews and approvals, both of which he described as “cumbersome processes” that take too long and make us uncompetitive with countries that are moving much faster. He also referred to the process for submitting and obtaining approvals for Investigational New Drug (IND) applications, which companies submit to test a product on humans.
“We’ve gotten into a mess,” Makary said, pointing to how far the U.S. has lagged behind China in Phase 1 clinical trials conducted in 2024.
Marty Makary, Commissioner of the Food and Drug Administration, speaks in the Oval Office at the White House on January 29, 2026.
Samuel Corum | Getty Images
He said the FDA is looking at “everything,” such as whether it can work with health systems and academic medical centers on the pre-IND process. This means when companies consult the FDA before officially submitting an application.
Makary said the Trump administration should “work with industry to help them bring more cures and meaningful treatments to the American public, because that is a shared bipartisan goal that we all want. And we will achieve it in this administration.”
China’s biotech ecosystem has flourished in recent years, fueled by massive government investment, a huge talent pool and accelerated regulatory reforms. Once known as a low-cost manufacturing hub that eliminates imitators, China is quickly becoming a global innovation hub.
Data from Global Data and Morgan Stanley show that China now conducts more clinical trials than the US, accounts for nearly a third of all new global drug approvals and is on track to reach 35% of FDA approvals by 2040.
U.S. policymakers have been under pressure to take action to boost innovation at home.
