The FDA’s operational structure around centers, each governing a particular regulatory or scientific area, dates back more than 40 years. It remains intact for now, but Rick Pazdur, former director of the agency’s Oncology Center of Excellence, believes the structure is outdated.
Regulation of small molecule drugs falls under the Center for Drug Evaluation and Research (CDER), while biologics are governed by the Center for Biologics Evaluation and Research (CBER). Both are anachronisms of the past that no longer need to exist, Pazdur said. Instead, it offers several drug treatment centers. For example, oncology should have its own center. Others could include neurology, cardiovascular disease, infectious diseases and even manufacturing.
“This is a golden opportunity for us, not to criticize and bemoan the agency, but to really step up and swing the bat so to speak,” Pazdur said during a panel discussion at an event hosted by STAT during, but separately from, the recent annual meeting of the American Society of Clinical Oncology in Chicago.
Pazdur is not involved in any of the changes at the FDA. His 26-year career with the agency ended last December, his last role being a brief stint as director of CDER. Pazdur acknowledged that the Trump administration was make changes to improve efficiency and reduce bureaucracybut he said how those changes are made matters. Rather than reaching consensus from the bottom up, changes were imposed from the top down. Pazdur said a fundamental principle that must be respected is that of separation between politics and scientific review of drugs. Over the past year, Pazdur said that wall has been broken down by political figures exercising authority over regulatory decisions.
Nicole Gormley left the FDA more recently, leaving her role as division director for hematologic malignancies last month. She said the agency was under extreme pressure, and some might even say it was under attack. As division director, she felt independent to do what was appropriate based on science. But that has changed under the current administration.
“The fundamental principles that underpin the agency were being called into question and that’s why I left,” she said.
Pazdur has other ideas for how the FDA could be improved, or even rebuilt. He suggested contacting academic centers to see if people from those institutions could come to the FDA temporarily, which would immediately alleviate some workload issues. He added that his time outside the agency showed him the need for additional perspectives. Of the three panelists, Harpreet Singh is the furthest from the FDA, having left her position as division director for oncology in 2024. She said that while she didn’t think she would change the regulatory decisions she had made, her absence from the agency had given her perspective and a deeper understanding of what she had asked companies to do as a regulator.
“For many, many reasons, a lot of what I was asking for was almost unachievable or very difficult,” Singh said.
The FDA is currently led by Acting Commissioner Kyle Diamantas, a regulatory attorney. Gormley said the FDA won’t be stable until it appoints a permanent commissioner. The agency also currently has acting directors from CBER and CDER, and Singh said she doesn’t think permanent directors will be named before the November midterm elections.
Pazdur said the responsibility for stabilizing the agency does not fall on one person. A group of people, regardless of political party, is needed to ensure a stable and functioning FDA, he said. One of the problems is that many people have left the FDA, and many of them didn’t do it by choice. Pazdur said it would be difficult to get people to come back. For Gormley, restoring the FDA as a functioning agency will be key to recruiting people wherever they come from.
“I think the agency should be created that way, so that it can operate independently, regardless of which administration it belongs to or not,” she said. “We need an independent agency that can focus solely on science. If you have that, I think you will attract good candidates.”
Will Pazdur be one of these recruits? Moderator Matt Herper asked Pazdur if he was interested in becoming the next FDA commissioner.
Pazdur opposed this.
“I will always be interested in having conversations with people,” he said. “As I’ve said before, I’ve lived my life at the FDA. It’s been my life. I want this place to succeed, and I’ll leave it at that.”
Photo: Getty Images, Sarah Silbiger