FDA chief warns U.S. is losing ground to China in early drug development, calls for faster trial approvals

Food and Drug Administration Commissioner Marty Makary warned that the U.S. is falling behind China in early-stage drug development and called for reforms that could streamline the process for starting trials on new treatments. 

In an interview with CNBC on Wednesday, Makary specifically pointed to three bottlenecks that he said cause the U.S. to fall behind on those early drug trials. 

These include hospital contracting as well as ethical reviews and approvals, both of which he called “clunky processes that take too long and are leaving us noncompetitive with the countries that are moving a lot faster.” He also pointed to the process for submitting and receiving approvals for Investigational New Drug, or IND, applications, which companies submit to test a product in humans. 

“We walked into a mess,” Makary said, referring to how behind China the U.S. was in terms of Phase 1 clinical trials conducted in 2024. 

He said the FDA is “looking at everything,” such as whether it can partner with health systems and academic medical centers on the pre-IND process. That refers to when companies consult the FDA before formally filing an application. 

Makary said the Trump administration should “partner with industry to help them deliver more cures and meaningful treatments for the American public because that is a common bipartisan goal that we all want. And we’re going to get it done in this administration.”

China’s biotech ecosystem has flourished over the last several years, driven by massive state investment, a vast talent pool and accelerated regulatory reforms. Once known for being a low-cost manufacturing base that pumps out copycats, China is rapidly evolving into a global innovation powerhouse. 

Data from Global Data and Morgan Stanley shows that China now conducts more clinical trials than the U.S., accounts for nearly a third of new global drug approvals and is on pace to reach 35% of FDA approvals by 2040. 

U.S. policymakers have been under pressure to take steps to boost innovation domestically.