Food and Drug Administration Commissioner Marty McCulley warned that the United States is lagging behind China in early-stage drug development and called for reforms that could streamline the process of starting trials of new treatments.
In an interview with CNBC on Wednesday, McCurry specifically identified three bottlenecks as reasons why the U.S. is lagging behind in early drug trials.
This includes hospital contracts and ethics reviews and approvals, both of which are “too slow and clunky processes, making us uncompetitive with countries that are moving faster,” he said. He also pointed to the process of filing and approving so-called investigational new drug applications, which companies submit to test their products on humans.
“We’re in a mess,” McCurry said, noting how far behind China the U.S. was in terms of Phase 1 clinical trials, which are due to take place in 2024.
Food and Drug Administration (FDA) Commissioner Marty McCulley speaks in the Oval Office of the White House on January 29, 2026, in Washington, DC.
Samuel Corum | Getty Images
He said the FDA is “looking at everything,” including whether it can partner with health systems or academic medical centers in the pre-IND process. This refers to companies consulting with the FDA before formally submitting an application.
He added that the Trump administration should “work with industry to bring more treatments and more meaningful treatments to the American people, because that’s a shared bipartisan goal that we all want.” “And we’re going to get it done with this administration.”
China’s biotech ecosystem has flourished in recent years due to large-scale state investment, vast talent pool, and accelerating regulatory reform. Once known as a low-cost manufacturing hub that spawned counterfeit goods, China is rapidly evolving into a global innovation powerhouse.
China currently conducts more clinical trials than the United States, accounts for nearly a third of global new drug approvals, and is on pace to reach 35% of FDA approvals by 2040, according to GlobalData and Morgan Stanley data.
U.S. policymakers are under pressure to take steps to foster innovation at home.
