[Reporter's Notebook] FDA staff exodus may spark delays, cost burden for Korean drugmakers

“Indeed, the clinical review period has been delayed, and we're considering whether to relocate our production base to the U.S.”

This is what a Korean drugmaker official recently told this reporter. The company is conducting clinical trials in the U.S., and the ongoing exodus of U.S. health officials—including those at the Food and Drug Administration (FDA)—is beginning to ripple through the Korean pharmaceutical industry. The impact is being felt not only by major players like Celltrion and Samsung Biologics but also by small- and medium-sized enterprises.

During the Covid-19 pandemic, the FDA led the global push to commercialize vaccines at record speed. The agency also paved the way for regulating cutting-edge modalities such as antibody-drug conjugates (ADCs) and gene therapies, including mRNA treatments, accelerating the arrival of innovative new medicines. But as regulatory talent continues to leave the agency, the consequences are now reaching Korean shores.

Companies preparing for U.S. clinical trials are likely to face delays in key processes. On top of that, the FDA may raise fees for marketing authorization reviews. Combined with Korea’s own recent hike in regulatory review fees by the Ministry of Food and Drug Safety (MFDS), Korean pharmaceutical companies could face growing cost pressures on both sides of the Pacific.

Analysts warn that in the long term, the FDA’s ability to review truly innovative drugs—especially first-in-class therapies—may be compromised. A reduced pool of expert reviewers could lead the agency to adopt a more conservative stance on breakthrough therapies.

Developing innovative medicines is a critical mission for Korea’s pharmaceutical and biotech sectors. But amid this regulatory uncertainty, there appears to be no unified response. Industry associations have not yet coordinated a collective position, and there is no visible action at the government level. Meanwhile, the global economic downturn and a sluggish domestic investment market are compounding the challenges facing drug developers.

This is not a crisis that individual companies can tackle alone. Institutions like the Korea Health Industry Development Institute (KHIDI), which champions Korea's rise as a global biotech hub, the MFDS, which seeks to lead on global regulatory standards, and key industry bodies such as the Korea Pharmaceutical and Bio-Pharma Manufacturers Association (KPBMA), KoreaBIO, and the Korea Biomedicine Industry Association (KoBIA), must step up. Their coordinated leadership is urgently needed.