FDA Commissioner Marty Makary said the U.S. is losing ground to China in early-stage drug development, particularly in the speed of launching first-in-human clinical trials.
He identified slow hospital contracting, ethics-review processes, and Investigational New Drug (IND) submissions as major U.S. bottlenecks, and said the FDA is considering ways to streamline pre-IND engagement with health systems and academic centers.
China’s biotech expansion has been supported by state investment, scientific talent, and regulatory changes that make trials faster and cheaper. It has moved beyond low-cost manufacturing toward developing and licensing novel medicines.
The shift is already influencing FDA policy:
the agency is trying to speed domestic early-stage research while maintaining scrutiny of trials and supply chains involving China, including concerns about genetic-data security and the transfer of Americans’ living cells for engineering abroad.
The underlying policy tension is competitiveness versus safeguards:
accepting more globally generated evidence can accelerate access to treatments, but reliance on China raises questions about data integrity, patient protection, supply-chain dependency, and national security.
Sources:
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