FDA veteran Richard Pazdur outlined his priorities for the next FDA commissioner but stopped short of putting himself forward as a candidate to lead the agency at an RBC Capital Markets event on Tuesday.
Former FDA oncology boss Richard Pazdur—who also briefly served as director of the Center for Drug Evaluation and Research—has sidestepped calls to put his name forward for the agency’s recently vacated top position.
Last week, a cadre of more than 100 biotech leaders were quick to recommend Pazdur for the job, penning a letter to President Donald Trump himself following Marty Makary’s sudden resignation.
During a keynote session at RBC Capital Markets’ global healthcare conference on Tuesday, however, Pazdur “declined to put forward his own candidacy for FDA commissioner,” the analysts wrote in a note to investors on Wednesday. But he “outlined a clear vision for what the next commissioner must bring,” the group added.
These deliverables include “concrete plans with timelines to restore confidence, preserve science-driven culture, and think outside the box bringing a bottoms up approach to the agency,” according to RBC.
Makary stepped down as FDA commissioner last week following pressure from the White House and rumors of his ouster. Last fall, Makary convinced Pazdur—a 26-year FDA veteran who led the agency’s Oncology Center of Excellence, which he founded in 2017—to take over as chief of the Center for Drug Evaluation and Research (CDER). Industry celebrated the appointment as a stabilizing choice for the evolving agency.
He left the FDA less than a month later, however, later revealing that he had been pressured by Makary to support the agency’s change from two pivotal trials to one. “[The] wall between the commissioner’s office and the review staff has been breached” under Makary’s leadership, Pazdur told The Wall Street Journal in February.
With Makary now gone, biotech wants Pazdur back.
“Decisional volatility, staff exodus, missed deadlines, and eroding scientific predictability at the FDA have created a crisis of confidence in America’s ability to remain a leader in biomedical progress,” the biotech execs wrote in their letter to Trump, which was posted on May 14 by the advocacy group No Patient Left Behind. “Solving it requires leadership with proven experience, unimpeachable scientific credibility, and a demonstrated track record of leadership and effectiveness—all qualities Dr. Pazdur has demonstrated throughout his time at the agency.”
Last April, newly appointed Health Secretary Robert F. Kennedy Jr. oversaw sweeping cuts across the Department of Health and Human Services (HHS), including the termination of more than 3,000 FDA staffers. During the RBC event, Pazdur “raised concerns that recent RIFs [reductions in force] have eroded irreplaceable institutional knowledge,” the analysts said.
Department leadership has also failed to solidify. Indeed, both the FDA and the CDC now lack permanent leadership, as do the FDA’s two main review divisions: CDER and its sister agency, the Center for Biologics Evaluation and Research (CBER). These agencies and departments have collectively been helmed by a total of 17 different people since Trump took office in January 2025.
Pazdur on Tuesday “acknowledged directionally positive current initiatives,” RBC wrote, including the FDA’s initiative to publish all complete response letters, leveraging AI in the drug review process, the use of real-world evidence and, notably, the single-trial policy. But he questioned the agency’s execution of these initiatives, and “stressed the importance of a firewall between science and politics,” the analysts added.
The FDA veteran “highlighted oncology’s regulatory history as a blueprint for broader reforms across single-trial policy, accelerated approval, and AdComs, called for emulating China’s clinical trial efficiencies (streamlined IRBs, less red tape, EHR-integrated databases), and encouraged biopharma to treat the FDA as a partner,” the analysts recalled.
Other names being bandied about to potentially assume the FDA commissioner’s role include former high-ranking FDA officials Brett Giroir and Stephen Hahn. Giroir, for his part, is not interested.
“I have asked that I not be advanced in consideration for this position,” Giroir wrote in a LinkedIn post on Tuesday, citing “significant” family health challenges and his increased commitment to OncoNano Medicine, for which he serves as board chairman.
For now, the FDA is being led in an acting capacity by Kyle “No drama” Diamantas, RBC wrote, a nickname picked up from a talk by the Capstone Group at Tuesday’s conference.
“Our speakers noted that the White House viewed former FDA Commissioner Makary as a distraction, with political interventions in drug approvals and vaccine decisions generating negative headlines that pulled attention away from priority messaging around TrumpRx and MFN,” RBC wrote on Tuesday. Diamantis’ appointment “signals that the White House is looking for stability, someone who keeps a low profile, focuses on food safety and nutrition (the MAHA angle), and avoids the controversy that plagued Makary’s tenure.”
