FDA chief warns U.S. is losing ground to China in early drug trials
Food and Drug Administration Commissioner Marty Makary warned that the United States is lagging behind China in early-stage drug development and called for reforms that could make it easier to launch trials on new treatments.
In an interview with CNBC on Wednesday, Makary specifically highlighted three bottlenecks that he said caused the U.S. to fall behind in early drug trials.
These include hospital contracts as well as ethical reviews and approvals; He called both of these “cumbersome processes that take too long and leave us unable to compete with countries that move much faster.” He also noted the process of submitting and receiving approvals for Investigational New Drug, or IND, applications in which companies submit a product to test it in humans.
“We’re in a mess,” Makary said, referring to how far the United States is behind China in terms of Phase 1 clinical trials conducted in 2024.
Food and Drug Administration Commissioner Marty Makary 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 partner with health systems and academic medical centers in the pre-IND process. This means companies must consult with the FDA before formally applying.
Makary said the Trump administration “needs to partner with industry to help them deliver more treatments and meaningful treatments to the American people, because that’s the bipartisan goal that we all want. And we’ll get that done in this administration.”
China’s biotech ecosystem has flourished in the past few years thanks to major government investments, a large talent pool and accelerated regulatory reforms. Once known as a low-cost manufacturing base that pumped out imitators, China is rapidly transforming into a global innovation hub.
Data: Global Data And Morgan Stanley It shows that China now conducts more clinical trials than the United States, accounts for nearly a third of new global drug approvals, and is on track to reach 35% of FDA approvals by 2040.
U.S. policymakers are under pressure to take steps to increase innovation at home.
