- Former FDA oncology chief says pharmaceutical industry isn’t taking political interference concerns seriously enough following his December departure.
- Speaking at STAT event during JPM Healthcare Conference, Pazdur describes “chaos” and “trauma” at agency after loss of key personnel.
Richard Pazdur, MD, the longtime FDA drug regulator who abruptly left the agency in December, used his first public appearance at the J.P. Morgan Healthcare Conference this week to deliver a warning: the pharmaceutical industry is not taking concerns about the FDA seriously enough.
Speaking at a STAT panel event in San Francisco on Monday, Pazdur was asked directly whether industry executives understood the gravity of the situation at the agency. His answer was unequivocal: “No.”
Quality Over Quantity
Pazdur, who spent 25 years at the FDA before abruptly leaving in December, described an agency in distress.
“We’re dealing with a staff that has gone through a lot of trauma in the past year, a staff that has been greatly reduced in number,” Pazdur told the audience. “The quality of many of the people that have left were really key people that had been in the agency for many years. And we have lost many quality people.”
He emphasized that replacing experienced regulators with new hires misses the point. “It’s not a numbers game,” he said, warning that sophisticated qualitative analysis (particularly important as the agency adopts artificial intelligence tools) requires veteran staff with deep expertise.
Political Interference Concerns
The veteran regulator, who was the fourth of five people to lead CDER in 2025, expressed concern about what he described as political interference in the drug approval process. He departed after less than a month in his new role, citing “promises made, promises not kept.”
“It’s terrible to see 25 years of work dismantled,” Pazdur said. “I did not leave because I wanted to leave.”
What’s Next?
In a LinkedIn post following the conference, Pazdur indicated he would continue advocating for FDA staff. “Now more than ever the staff at the agency need our support,” he wrote. “As I told STAT, the FDA’s greatest asset are its people.”
The Department of Health and Human Services has stated that “all decisions are grounded in evidence-based science and the agency continues to operate as a stable, science-based regulator.”
