The US Food and Drug Administration is considering raising review fees for drugs developed using foreign clinical data, a move that could significantly impact Korean pharmaceutical and biotech companies.
According to industry sources on the 28th, the FDA discussed amending the Prescription Drug User Fee Act (PDUFA) to offer fee reductions for companies conducting Phase 1 clinical trials in the United States, according to recently released minutes from its industry operations committee meeting.
The agency is also reportedly considering imposing higher fees or requiring annual payments for companies that rely solely on overseas clinical data without conducting trials in the US. With the current legislation set to expire in 2027, detailed policy directions are likely to be finalized next year.
The changes are expected to present both opportunities and challenges for Korean companies. For contract development and manufacturing organizations (CDMOs) with production and development bases in the US, this could create new opportunities for contract development services including clinical trial materials. However, biotech firms that have pursued technology licensing deals based on domestic Phase 1 clinical data may face increased costs as they would need to conduct early-stage trials in the US.
"This appears to be a policy response to counter China's rapidly growing clinical trial capabilities," said Oh Ki-hwan, director of the Bio-Economy Research Center at the Korea Biotechnology Industry Organization. "For biotech companies targeting the global market, establishing capabilities in the US is becoming essential."
