Pazdur Recommends Restructuring FDA

Former Oncology Center of Excellence and short-time CDER director Richard Pazdur says it’s time to restructure the agency’s organization into various new Centers. As reported by MedCity News, Pazdur appeared on a STAT panel during but apart from the recent annual meeting of the American Society of Clinical Oncology and said that the current structure in which CDER regulates small molecule drugs and CBER regulates biologics is outdated and should go away.

The structure he recommends would have multiple drug Centers, including for oncology, neurology, cardiovascular, infectious diseases, and even manufacturing, the online post says.

“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. While acknowledging that the Trump administration wants to make changes at FDA to improve efficiency and reduce bureaucracy, he said that how such changes are made is important, and that the administration was imposing change from the top down, rather than building consensus from the bottom up.

He stressed that the core principle of maintaining a firewall between politics and the scientific review of drugs must be restored, since in the past year, the wall has been breached by political appointees exercising authority over regulatory decisions.

Pazdur also proposed reaching out to academic centers to see if some of their staff could come into the agency on temporary duty to reduce some of the pressure on the staff that remains after massive reductions in force.

He said that responsibility for stabilizing the agency does not fall to a single person. Rather, he said, a group of people, irrespective of political party, is needed to ensure a stable and functional FDA. He noted that many people had left the agency, often not by their own choice, and it will be hard to get them back.

Asked if he would consider an appointment as commissioner, Pazdur gave a non-committal non-answer. “I will always be interested in having conversations with people,” he said. “I have lived my life at FDA. It has been my life. I want the place to succeed, and I will leave it at that.”

Also appearing on the panel was Nicole Gormley, former director of the Division of Hematologic Malignancies. She said that while she had felt she had the independence to do what was appropriate based on science, that changed under the Trump administration. “The core principles that undergird the agency were under challenge, and that’s why I left,” Gormley said.

She said that restoring FDA as a functional agency will be a key to recruiting new people to work there. “I think the agency needs to be set up that way, where it can function independently, no matter what administration is in or out,” Gormley said. “We need to have an independent agency that can just focus on the science. If you have that, then I think you’ll attract good candidates.”