Gloomy was the mood as the former director of the FDA’s Oncology Center of Excellence (OCE), Richard Pazdur, fielded questions about the state of the FDA during an AACR-Oncology Partnering event in San Diego. Padzur offered a candid look at an agency he helped shape for more than two decades.
He described a workforce under strain, pointing to what he called a “palpable sense of anxiety” following staffing cuts, leadership uncertainty, and shifting priorities. “It has not been a pleasant situation working in the agency over the past year,” he said at one point.
Pazdur, who was at the agency for 26 years, resigned in December 2025 just weeks after being appointed to the lead the FDA’s Center for Drug Evaluation and Research (CDER) division.
Pazdur expressed concern about the “disheartening” decline in the number of Oncology Drugs Advisory Committee meetings, noting that it obscures the thinking behind the FDA’s approval decisions, which he said is “probably more important than the actual discussion of a specific drug.”
“I’ve been disheartened about, over the past year or so, a decrease in the number of advisory committees, and there have been public statements by this administration that they don’t believe in advisory committees,” he said. “I totally disagree with that. It’s not only the importance of the drug under consideration, but also the thinking of what the FDA is formulating decisions on.”
He outlined several ways the process could improve. Advisory meetings should be more issue focused rather than repeating large volumes of data. He also called for broader and more transparent selection of committee members, with positions advertised and applicants reviewed by a diverse group that includes regulators, industry, and patient representatives to guard against any bias. That, he said, would strengthen rigor and trust.
Acknowledging the current reality of political bias sneaking into the advisory process, he said ODAC needs qualified people on the committees.
“My biggest fear is we do not want committees chosen where behind the scenes people are selected based on already known ideologies,” he said.
In the past, he said, there was a clear firewall between political appointees and career staff, which protected scientific decision making. Now, he suggested, that boundary has eroded. He pointed to the so-called “fork in the road” letter sent to federal employees early in the administration, which encouraged staff to consider leaving service and signaled that conditions could worsen if they stayed. That message, followed by staffing cuts and unclear leadership structure, contributed to what he described as “low morale” and a “palpable sense of anxiety” across the agency.
“How would any of you feel if you got that letter?” Padzur asked. “It certainly does not endear any confidence … regarding your job.”
He lamented that many of the senior and midcareer staff who left the agency, who had career options outside the agency because of their credentials, had expertise the FDA relied on.
He also cautioned against looking at hiring numbers, drawing attention to a deeper loss within the agency. “I’d like to remind people that it’s not about the numbers of people that are hired,” he said. “It’s really about the quality of people that have left.”
That loss comes at a time of major transition as AI is incorporated into more and more regulatory processes.
“AI is going to have a profound effect on the agency and how we review things,” he said, explaining that routine data analysis that once took reviewers hours or weeks can now be done in seconds.
As a result, the FDA will need a different kind of workforce. “They’re not just going to be number crunchers,” he said.
Instead, Pazdur said, the agency will depend more on experienced clinicians and scientists with deep knowledge of disease and the flexibility to adapt as drug development evolves. “We’re going to need a workforce that is much different,” he said, adding that reviewing the growing number of therapies will be “a heavy lift” that requires both expertise and regulatory flexibility.
On drug development, Pazdur warned against chasing early response rates at the expense of long term outcomes. High doses that produce strong early signals may not be sustainable, limiting real benefit on endpoints like overall survival.
