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.
That includes hospital contracting as well as ethical reviews and approvals, both of which he called “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 so-called 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.
