Food and Drug Administration Commissioner Marty Makary warned that the United States was lagging behind China in early drug development and called for reforms that could streamline the process of starting trials of new treatments.
In an interview with CNBC on Wednesday, Makary specifically highlighted three bottlenecks that he says are causing the United States to fall behind in these early drug trials.
These include hospital contracts and ethics reviews and approvals, which he called “clumsy processes that take too long and leave us uncompetitive compared to countries that are moving much more quickly.” He also highlighted the process of submitting and receiving approvals for investigational new drug applications, or INDs, that companies submit to test a product on humans.
“We have fallen into trouble,” Makary said, referring to China’s lag behind the United States in terms of Phase 1 clinical trials being conducted in 2024.
Food and Drug Administration Commissioner Marty Makary speaks in the Oval Office of 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 on the pre-IND process. This refers to when companies consult with the FDA before officially filing an application.
Makary said the Trump administration should “partner with industry to help them deliver more cures and meaningful treatments to the American public, because that’s a shared bipartisan goal that we all want. And we’re going to achieve it in this administration.”
China’s biotech ecosystem has flourished in recent years, driven by massive public investment, a vast talent pool and accelerated regulatory reforms. Once known as a low-cost manufacturing base that churns out copycats, China is rapidly evolving into a global innovation powerhouse.
Data from Global Data and Morgan Stanley show that China now conducts more clinical trials than the United States, accounts for nearly a third of new drug approvals worldwide and is on track to reach 35% of FDA approvals by 2040.
U.S. policymakers are under pressure to take steps to boost innovation domestically.