At the Milken Institute’s 2025 Future of Health Summit, FDA Commissioner Marty Makary reaffirmed that the U.S. Food and Drug Administration (FDA) remains “strong” despite recent turnover among senior leaders. Makary emphasized that a new, collaborative culture within the agency has replaced the fragmented structure of the past—helping ensure stability, accountability, and continued regulatory progress.
A Shift in Leadership and Culture
Over the past year, several top FDA officials have departed, including George Tidmarsh, former Director of the Center for Drug Evaluation and Research (CDER), who resigned in late October. These changes prompted speculation about continuity within the agency’s leadership.
Addressing these concerns, Makary said the FDA’s foundation remains firm, crediting the strength of its workforce and the shift toward a team-based culture. “We have 16,000 employees. We regulate 20% of the U.S. economy,” Makary stated. “It’s a large organization, and the centers were running their own secret governments… so we broke that up.”
According to Makary, the agency has moved away from what he called a “fiefdom culture,” in which the six major product centers operated independently. The new model, he said, encourages collaboration across divisions and has already accelerated internal reforms.
Efficiency, Reform, and Technological Innovation
Makary assured attendees that the FDA continues to meet its review deadlines, funding goals, and user fee targets. “The trains are running on time,” he said. “Hopefully faster now that we are cutting idle time—not cutting corners on safety, but cutting idle time in the review.”
The Commissioner also previewed several upcoming reforms, noting that the agency is “challenging deeply held assumptions” about drug development. Among these are the traditional reliance on animal testing and the decade-long timeline to bring new therapies to market.
Makary said computational modeling and continuous clinical trial designs could transform the development process, reducing costs and shortening approval timelines. He added that the U.S. must become more competitive in attracting Phase I trials, which currently occur more frequently in countries like China and Australia.
“We can use new technology to run continuous trials and have regulators look at endpoints in the cloud,” Makary said. “We’ve got to try new things.”
Accelerating Review Pathways
Makary also discussed the FDA’s goal of streamlining its review process, saying that in some cases, decisions could be reached within weeks. He highlighted the agency’s new Commissioner’s National Priority Voucher (CNPV) pilot program, which expedites reviews of products deemed critical to national security or public health.
Following his remarks, the FDA announced six new drugs accepted into the CNPV program, including candidates targeting cancer, sickle cell disease, obesity, and drug-resistant tuberculosis in children.
Addressing Broader Health Policy Goals
Makary concluded by emphasizing that improving the nation’s healthcare system means addressing cost and access—not just incremental policy adjustments. “We’re not interested in 1% or 2% reductions in drug prices,” he said. “We’re interested in massive reductions.”
At EMMA International
At EMMA International, we recognize that effective regulatory systems depend on strong leadership, scientific innovation, and cross-functional collaboration—values reflected in the FDA’s evolving culture. As the agency advances toward faster, more integrated review models, manufacturers must ensure their development and submission strategies are equally agile.
Our team supports life-science organizations in implementing risk-based quality systems, preparing for regulatory submissions, and aligning with FDA modernization initiatives.
For more information on how EMMA International can assist, visit www.emmainternational.com or contact us at (248) 987-4497 or info@emmainternational.com.
Reference:
Regulatory Affairs Professionals Society (RAPS). Makary Says FDA Is “Strong” Despite Recent Leadership Turmoil. (November 2025).
Milken Institute. Future of Health Summit 2025: Leadership and Innovation in Regulatory Science. (2025).
