Former FDA commissioners say China's scientific progress and faster trial start-up speed are driving more Phase 1 trials there than in the U.S.

A count of Phase 1 starts is a count of registrations. It records how many first-in-human studies opened in a jurisdiction. It does not weigh them by size, by quality, or by the chance that the compound behind any one of them reaches a marketing application. The op-ed's own sentence names two causes: the shift is "a reflection of real scientific progress underway in China, but also the country's ability to move new compounds into Phase 1 trials more quickly than the U.S. can," the authors wrote ^[5]. The op-ed gives neither cause a share ^[17].

The cuts they describe land on scheduling work. The April 2025 reductions eliminated entire offices that drafted policy and regulations, and hit the project managers who keep reviews on schedule and the teams that support inspectors ^[8]. The authors put the agency's ability to improve its review functions on the product centers, where those project managers sit ^[18].

The loss figure they give is a headcount: about 3,500 employees in the layoffs, plus more in the voluntary departures that followed ^[7]. The piece does not convert that into review times, missed goal dates, or applications delayed ^[16]. If regulatory capacity is what decides where a drug launches first, the evidence for it is review clocks.

On who does reviews, the two are direct. "The commissioner and a few political advisers can't review applications on their own, and should not be involved in those matters," they wrote ^[10]. The work takes thousands of career physicians and scientists ^[11]. What they ask of the next commissioner is specific: "A commissioner owes them clear priorities, an achievable set of well-defined policy goals, and sufficient qualified staff to do the work," they wrote ^[12].

The products waiting on those centers are the hard ones. Gene therapies are being crafted for individual patients, and cell therapies first used against cancer are being repurposed for autoimmune disease ^[14]. The authors credit Overton with practical policy work, including the initial Covid-19 response, and with close relationships with White House leadership ^[15]. They are plain about the failure they want her to avoid: ideas "for everything from modernizing clinical trials to changing the regulation of testosterone have withered somewhere between the speech or television hit announcing them and any practical, reliable policy change that would see them implemented," they wrote ^[13].