Pazdur Warns About Political Interference, Upheaval At FDA

Former FDA Oncology Center for Excellence director Richard Pazdur is warning that political interference and internal upheaval are eroding the agency’s ability to function as a science-driven organization, according to public remarks delivered at a biotech industry gathering in San Francisco. He said the traditional firewall between scientific reviewers and political leadership has been weakened, creating what he described as growing “chaos” inside the agency. Pazdur’s comments were made during a public discussion held alongside the J.P. Morgan Healthcare Conference and were reported by STAT News.

Pazdur, who spent decades overseeing cancer drug approvals at FDA until he retired last month due to management tensions after recently accepting the position as CDER director, said that decisions historically grounded in scientific judgment are increasingly vulnerable to political pressure. He warned that this shift risks undermining confidence in the agency’s regulatory decisions and could ultimately affect patient safety.

According to accounts of the event, Pazdur criticized what he characterized as a breakdown in internal processes, including greater involvement by senior political appointees in matters traditionally handled by career scientists. He also raised concerns about transparency, saying that key discussions affecting drug approvals are sometimes occurring outside established review channels.

While Pazdur did not point to specific recent drug decisions, he said the broader trend threatens the credibility of the FDA at a time when the agency faces intense scrutiny from Congress, the courts, and the public. “Once you lose trust in the system,” he cautioned, “it’s very difficult to get it back,” according to reports of his remarks. Pazdur suggested that continued politicization could make it harder for the agency to recruit and retain experienced scientific staff.

Despite the criticism, Pazdur emphasized that FDA reviewers remain committed to evidence-based decision-making and patient protection. He framed his remarks as a warning rather than a prediction, urging policymakers to preserve the agency’s scientific independence.

The remarks quickly resonated across the biopharma sector, where the FDA’s credibility and predictability are seen as critical to drug development and investment decisions.