FDA Commissioner Warns US Falling Behind China in Early-Stage Drug Development
FDA Commissioner Marty Makary identified hospital contracting, IRB processes, and IND application timelines as key bottlenecks slowing US early-phase trials. China now conducts more clinical trials than the US and accounts for nearly a third of new global drug 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.
Makary identified hospital contracting, institutional review board (IRB) processes, and Investigational New Drug (IND) application review timelines as key bottlenecks that may be slowing first-in-human and early-phase studies in the US. He called hospital contracting as well as ethical reviews and approvals "clunky processes that take too long and are leaving us non-competitive with the countries that are moving a lot faster." He also pointed to the process for submitting and receiving approvals for Investigational New Drug 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 one 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.
Under current US law, sponsors must submit an IND application to the FDA before initiating clinical trials in humans. The agency has 30 days to review the application and may impose a clinical hold if safety or protocol concerns arise. While the statutory timeline is fixed, pre-IND preparation, sponsor–FDA interactions, and post-submission queries can extend development timelines. Additionally, multicenter trials often require negotiation of site-specific clinical trial agreements and budget terms, as well as IRB approval, processes that may vary widely across institutions.
China, by contrast, has implemented regulatory reforms in recent years aimed at accelerating drug development. In 2017, China's National Medical Products Administration joined the International Council for Harmonization, committing to align technical requirements with global standards. Subsequent reforms have included implied approval mechanisms for INDs if no objection is raised within a specified period and prioritization pathways for innovative therapies.
Data from Global Data and Morgan Stanley show 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. Several analyses have documented a substantial increase in China-originated first-in-human trials and oncology innovation programs over the past decade.
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," he added. "And we're going to get it done in this administration."
The US continues to lead globally in total biopharmaceutical R&D spending and in the number of new molecular entities approved annually. Additionally, the FDA's 30-day IND review window is relatively short compared with some international counterparts. The more salient issue may be system-level fragmentation rather than statutory review times.