As China Surges in Biopharma, Ex-FDA Chief Urges U.S. to Act Fast

Former FDA commissioner Scott Gottlieb recently appeared on an Endpoints News video series to share insight into China's rapid ascent in the biotechnology innovation race. His assessment included a call-to-action for American policymakers and industry leaders, describing China’s life sciences industry as not only a sector that is surging but here to stay.

To maintain U.S. leadership, Gottlieb emphasized the need to support America’s industry through regulatory reform, including processes around early-stage clinical trials.

China's innovation pace accelerated so dramatically over the past five years that what was once merely a manufacturing advantage has become a fundamental shift in the competitive landscape itself.

"What's really been jarring is ...they're not just matching U.S technology but in many ways eclipsing it," Gottlieb said.

The game-changer is China's newfound ability to produce high-quality innovative biologics, traditionally an American stronghold. Rather than simply manufacture drugs discovered in the U.S., China is now registering more clinical trials than America and developing its own cutting-edge treatments.

Chinese-based biotech companies are raising capital at higher rates, creating a robust ecosystem that extends far beyond manufacturing.

"What you're going to see,” Gottlieb said, “is more Chinese tech companies fully developing compounds, running global clinical trials, maintaining rights to those compounds globally or at least in China, and then just licensing away the U.S. rights now that they have capital markets where they're able to raise that capital there."

This speed advantage stems partly from having fewer patient protections in early-stage studies. It also reflects a more streamlined regulatory system overall.

"We're still better at discovery here, I think, but they're better at early-stage execution in China,” Gottlieb said.

Meanwhile, American companies face delays and uncertainty, factors that Gottlieb identified as the primary drivers pushing clinical trials overseas. Combined with significantly lower base prices in China, this creates a powerful incentive for companies to conduct research abroad.

Perhaps most concerning is Gottlieb's assessment that this shift represents a permanent disruption rather than a temporary phase.

"If they're able to evolve their own discovery engine as quickly as they seem to be able to do it, they're going to be an innovation powerhouse in their own right from soup to nuts,” Gottlieb said. “And then, they become much more of a competitor for the U.S.-based biotech ecosystem, which has really led the world for decades."

While China has yet to develop a robust domestic market for their drugs, Gottlieb warned that once they do, the competitive threat will become exponentially more serious, hence the need for regulatory reform now.

The stakes couldn't be higher.

This is about maintaining American leadership in an industry fundamental to both economic prosperity and public health. The question isn't whether China will continue advancing, it's whether the U.S. will adapt quickly enough to protect innovation and safeguard its national security.