The FDA’s operational structure, built around specialised centres each overseeing a distinct regulatory or scientific area, has remained largely unchanged for more than 40 years.
Rick Pazdur, former director of the FDA’s Oncology Center of Excellence, believes this long-standing framework is now fundamentally outdated and in need of serious reform.
Currently, regulation of small molecule drugs falls under the Center for Drug Evaluation and Research, while biologics are handled by the Center for Biologics Evaluation and Research.
Pazdur argues that both of these centres are anachronisms of the past that no longer need to exist in their current form.
In their place, he proposes a restructured model featuring multiple centres organised around specific therapeutic or scientific disciplines rather than broad drug categories.
Under his proposed model, oncology would have its own dedicated centre, with other potential divisions covering neurology, cardiovascular disease, infectious disease, and manufacturing.
The proposal represents a significant philosophical shift in how the agency would approach oversight, moving away from chemistry-based classifications toward disease-focused regulatory frameworks.
Speaking at a panel discussion hosted by STAT during, but separate from, the recent annual meeting of the American Society of Clinical Oncology in Chicago, Pazdur made clear his position was forward-looking.
“This is a golden opportunity for us, not to criticize and bemoan the agency, but to really step up to the plate and swing the bat so to speak,” Pazdur said.
The comments come at a moment of heightened scrutiny of federal health agencies in the United States, with debate intensifying over how regulators can best serve public health and scientific progress.
A disease-specific centre structure could, in theory, allow regulators with deep therapeutic expertise to oversee the full spectrum of treatments in their field, from small molecules to biologics.
Whether the FDA’s existing institutional culture and political environment would support such a sweeping reorganisation remains an open and heavily contested question among industry observers.