SAN FRANCISCO, December 2, 2025 — A veteran Food and Drug Administration regulator publicly voiced serious concerns about political interference at the agency, just weeks after his unexpected departure. Richard Pazdur, who until last month directed the FDA’s Center for Drug Evaluation and Research, warned of a weakening separation between political appointees and the scientists who review drugs.
Concerns Rise Over Political Influence at FDA
Former FDA official Richard Pazdur alleges a concerning shift in agency dynamics, raising questions about drug approval transparency.
- Pazdur expressed alarm over the erosion of the firewall between political leadership and drug reviewers.
- He questioned the transparency surrounding a new voucher program granting accelerated drug reviews.
- Pazdur stated his departure from the FDA was not voluntary, hinting at deeper issues within the agency.
Speaking at an event alongside the J.P. Morgan Healthcare Conference on Monday evening, Pazdur also raised questions about a voucher program established to expedite the review of certain drugs. This program, he argued, lacks sufficient transparency, particularly regarding selections made by officials from the Trump administration. The core issue, he suggested, is that decisions about which drugs receive priority review are becoming increasingly politicized.
What is the role of the FDA in ensuring drug safety and efficacy? The FDA is responsible for protecting public health by ensuring that drugs are both safe and effective before they are allowed on the market. This process relies on rigorous scientific review, free from undue political influence.
“It’s terrible to see 25 years of work dismantled,” Pazdur told reporters. He emphasized that his decision to leave the FDA was not of his own volition, adding, “I did not leave because I wanted to leave.” Pazdur founded the FDA’s oncology center and has been a key figure in drug regulation for decades.
The voucher program, initially intended to incentivize the development of drugs for rare diseases, has faced criticism for potentially prioritizing certain applications based on political considerations rather than scientific merit.
Pazdur’s remarks come at a time of heightened scrutiny of the FDA, with some observers questioning the agency’s independence and its ability to make objective decisions. His concerns underscore the importance of maintaining a clear separation between scientific evaluation and political influence in the drug approval process.
