Oct. 15, 2025 – Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.

“As many know, there has been a huge reduction in force at the FDA earlier this year, which was part of sweeping reorganization that impacted the U.S. Department of Health and Human Services (HHS),” panel moderator Kelly Cho, senior managing associate at Sidley Austin LLP, said in opening remarks. “Between March and April, the HHS terminated 35,000 FDA employees, resulting in a 20% reduction in workforce.”

The major structural, organizational and personnel changes at the FDA come under the helm of President Donald Trump’s administration. The policy changes affected not only the FDA, but also the National Institutes of Health (NIH) and the CD

With talks of a second wave of layoffs following the  U.S. government shutdown Oct. 1, the changes go just beyond “huge” or “sweeping,” Chung Sang-mok, president of Biostar Group, commented: “I would label them as radical, meaning that these are changes that have never occurred before.”

As BioWorld reported, among other developments, the latest shuttering of the U.S. federal government blocked the FDA’s acceptance of 2026 user fees until Congress agrees on a continuing resolution (CR) or a 2026 appropriation bill. For the duration of the funding lapse, the agency has limited “activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.” Chung pointed out that the first wave of layoffs hit agencies like the CDC and NIH harder than the FDA, mostly because the latter is sustained by user fees, making it less dependent on fluctuations of government budgets. And while most of the 20% of employees furloughed pertained to administrative or human resource (HR) personnel, Chung said, the damage was done also to the psyche of the agency, with people “hesitant to … buy a new pen … or a printer/copy machine” and unsupported in administrative tasks.

Importantly, senior decision makers at the agency began leaving “voluntarily,” Chung said.

These officials with “beautiful scientific minds,” he said, had served the industry through their vocation to regulatory science before resigning. Peter Marks’ departure as the director of the FDA’s Center for Biologics Evaluation and Research (CBER) was a poignant example. “Marks was well respected in the industry, internally and externally, and was responsible for reviewing drugs without bias.” His ouster, in hindsight, was almost inevitable after Robert F. Kennedy Jr. became HHS secretary, as BioWorld reported, with the increasing pressures regarding vaccine policies during the COVID-19 pandemic. Like Marks, officials from decision makers to on-site examiners at the agency, often “with underpaid jobs [compared to industry], but dedicated to regulation and the science behind it, began leaving [for industry],” Chung said. Marks most recently joined Eli Lilly and Co.

Cho agreed, noting the departure of renowned senior leaders at the agency including Marks, Janet Woodcock, Jacqueline Corrigan-Curay, Jeffrey Shuren, Robert Temple “and many more.” Coupled with the rollout of new leadership, including RFK Jr. and new CDER director appointments, “people are unsure of what the agency’s policy priorities are now,” Cho said. “Vinay Prasad is the new head of the FDA’s biologics center, for example, but he was previously critical of the accelerated approval process, pushing for higher clinical standards such as randomized clinical trials.”

“He was also critical of Peter Marks for his decision to approve Sarepta Therapeutics Inc.’s gene therapy,” she said. “… But since he was appointed to the CDER this year, we have seen him willing to show regulatory flexibility toward gene therapy.

“Only time will tell,” she added. How changes at the agency will impact future innovation may be difficult to assess now, but Chung noted that an impact will be likely: “Applying law to innovation does not work; you need regulatory scientists working with innovators [to realize gains.]”

Upheavals collide with China’s pivot to innovation

Simultaneously, “we are hearing that China will outpace the U.S. in [new drug R&D] and the life sciences,” Cho said. Word on the street, she said, is that China’s National Medical Products Administration (NMPA) could “outpace” the FDA, and that the Chinese agency may be moving faster and more efficiently than the U.S. agency.

Moon Han-lim, CEO of Seoul-based MediRama, affirmed China’s increasing levels of innovation in the life sciences but cautioned against what that entails for South Korea’s biomedical industry.

“China has been the backbone of manufacturing. … It also has a huge population,” Moon said. “When I attended CPHI [Shanghai] 2025, there were 100,000 people in attendance, Most were [exhibitors] … but when I walked around, I saw that Chinese innovation is increasing, much more than the U.S.”

“At the American Society of Clinical Oncology and American Association for Cancer Research conferences, I saw that in every session, about two-thirds of studies were presented by Chinese researchers. A huge number,” she said. “Furthermore, [China President] Xi Jinping pledged to redirect the country’s strategic base from manufacturing to innovation, which [has scared] the U.S.”

Moon then painted a picture of a pyramid between the U.S., China and South Korea. “For South Korea, this could be a good opportunity, [especially] if the U.S. could turn reliance here [for manufacturing] than China. But it could also be a crisis if our ties to the U.S. harms our relationship with China.”

 “I believe we need to piggyback on China’s [innovation],” she continued, “but at the same time, we are walking a tightrope. We need to look at the U.S. and also look at China. We need to have a ‘me first’ approach and try to bring in manufacturing, but we also need to read the room.”

On the regulatory front, Chung noted radical changes happening in China’s approach to drug review and approvals.

“In new drug R&D, the U.S. and Europe can be said to operate on similar scientific principles,” with a solidified sequential process for obtaining regulatory clearance, Chung said. “Now China is saying, I do not care about other countries — we are doing it according to our clinical practice.

“As someone working in new drug R&D, the situation requires, out of necessity, routine checking [of] what is happening in China now,” he said.

In recommendations to Korean companies that often face the “Korean discount” on the global stage, Chung stressed one way to overcome the multiple uncertainties is to “frontload regulatory strategy,” instead of using a bottom-up or “parallel” approach to engaging with regulatory bodies. Drafting a plan to “dance with the health authority” early on could be the differentiating factor for biotech companies, particularly in a volatile macro-environment, he stressed.

View BioWorld’s reporting on the impact of the Trump administration’s policy changes.