Scott Gottlieb, who served as FDA commissioner during the first Trump administration, wrote in a JAMA editorial that China is speeding drugs to market and could potentially surpass the U.S. in the innovation game.
Former FDA commissioner Scott Gottlieb is concerned that the U.S. is losing its pole position in the global biopharmaceutical race, writing in an editorial that the nation is falling behind China and the rest of the world.
Specifically, Gottlieb warned in an editorial published last week in the Journal of the American Medical Association (JAMA) that NIH budget cuts threaten American innovation while other nations, particularly China, speed their ability to get new drugs to market.
“Even as US policymakers fixate on geopolitical rivalry with China,” Gottlieb wrote, “remarkably little attention is being paid to the risk that the US might surrender its strategic edge in biomedicine, a loss every bit as damaging as falling behind in semiconductors, rare earth minerals, or military hardware.”
Gottlieb’s concerns were echoed by analysts. “Dr. Gottlieb points to a critical disconnect in American policy,” Steven Grossman, a policy analyst and expert who writes the FDA Matters blog, said in an email to BioSpace. “On the one hand, we are determined to stay ahead of China economically and militarily. On the other hand, we are not supporting biomedical innovation, an area where the US is dominant and China our chief rival.”
Gottlieb coaxed the U.S. to implement artificial intelligence technology in clinical testing, with the hope that AI can be used for “predictive value” in finding adverse effects in preclinical studies and to help rely less on animal testing—efforts that the FDA is already pursuing.
The ability to get through early clinical trials is China’s strength, Gottlieb writes, but the U.S. still has an advantage. Where China can get new drugs through the pipeline more quickly, clinical datasets from the U.S. are still broadly viewed as more reliable by the broader pharma industry and its regulators than those derived from Chinese trials.
“While Chinese regulators allow new compounds to advance into early-stage clinical trials with greater ease, the data from their later-stage, human trials are still viewed skeptically by US regulators and drug companies,” Gottlieb wrote.
The U.S. keeping its edge in pharmaceutical innovation will keep control of technology that shapes “the health and security of U.S. citizens” in the U.S.’s hands, he added. The connection between the pharma sector and national security has been front-of-mind for the Trump administration. In April, the U.S. Department of Commerce launched an investigation into the national security implications of importing pharmaceutical products, the outcome of which could support pharma-specific tariffs. And in August, President Donald Trump issued an executive order aimed at making the supply chain more resilient.
“In the long run, maintaining a decisive edge in [medicine and pharmaceuticals] ensures US autonomy, preventing other nations from controlling the technologies that shape the health and security of US citizens in such key goals of reducing the burden of chronic disease and addressing unmet medical needs.”
This is the second time Gottlieb has spoken up this year to support the use and regulation of AI at the FDA. In February, he wrote an op-ed, also in JAMA, exhorting the introduction of AI technology, like ChatGPT4, into FDA decision-making and electronic medical records, while also advocating for new legislative regulation from Congress.
For the most part, Gottlieb stayed away from directly criticizing the Trump administration in his new article, only mentioning that the administration, which in recent months has introduced mass layoffs across the Department of Health and Human Services and canceled research grants in large blocks, is “fraying the partnership between government and academia that made US biomedicine the envy of the world.”
“Recent efforts to chip away at institutions like the FDA and National Institutes of Health,” he concluded, “have undercut some of the very offices responsible for driving these kinds of policy innovations, making thoughtful reform harder to achieve.”
