type: timeline_event
Dr. Richard Pazdur, the FDA's highly respected director of the Oncology Center of Excellence and newly appointed director of the Center for Drug Evaluation and Research (CDER), filed papers to retire at the end of December 2025, just three weeks after accepting the CDER role on November 11, 2025. He informed FDA leaders of his decision at a meeting on Tuesday, December 2, 2025. Pazdur's abrupt departure came after clashing with FDA Commissioner Marty Makary over what Pazdur saw as political interference in drug review decisions.
During his 26-year tenure at the FDA, Pazdur pioneered the agency's approach to cancer drug regulation and founded the Oncology Center of Excellence in 2017. He had initially been reluctant to accept the CDER director position, reportedly turning down the job offer initially, and only agreed after Makary assured him he would have full autonomy without political interference. However, those assurances quickly "fell flat" as Makary and vaccine chief Vinay Prasad began inserting themselves into drug review decisions.
Pazdur raised specific concerns about Makary's Commissioner's National Priority Voucher (CNPV) program, which would offer expedited review to drugs that align with "national priorities." Pazdur warned that the program was not transparent and could be illegal, privately expressing concerns about the legality and pace of plans to expedite drug approvals. He also privately mused about the broader "destruction of the American medical system" under the current leadership.
Pazdur's resignation marked him as the fifth person to lead CDER in 2025, highlighting unprecedented leadership turmoil at the FDA under the Trump administration. Other high-profile departures in 2025 included vaccine chief Peter Marks, who left in March and publicly accused HHS Secretary Robert F. Kennedy Jr. of forcing him out after Marks spearheaded Operation Warp Speed during Trump's first term, and George Tidmarsh, who resigned abruptly in November amid allegations of involvement in an extortion scheme.
The pharmaceutical and biotechnology industries reacted with alarm to Pazdur's departure. Biotech stocks fell 1% on the news, with the S&P Biotech ETF sliding after the announcement. RBC Capital Markets analyst Brian Abrahams, who had described Pazdur as "arguably the most qualified candidate in the entire healthcare ecosystem" for the CDER role, characterized the retirement as a "significant, sudden and surprising turn" that "raises concerns over the future direction" of CDER and the FDA's "ability to maintain its current pace of progress."
BIO CEO John Crowley issued a strong warning about the implications of continued FDA leadership turmoil: "This constant turmoil is undermining America's leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China." He called for an end to the "constant turmoil" and urged the administration to "right the ship," noting that Pazdur "exemplifies the type of expert and steady leadership that has made the United States the home to the world's leading medical breakthroughs." John Maraganore, founder of Alnylam Pharmaceuticals, called the news "Really bad news" and described Pazdur as "a National Treasure for efforts in bringing safe and effective cancer medicines to patients."
Cancer patient advocacy organizations expressed deep concern about losing Pazdur's expertise during a critical period. The American Society of Clinical Oncology (ASCO) stated that "Pazdur will be known as a visionary leader who dedicated his tenure at FDA to doing everything possible to enhance patient access to safe, effective and improved cancer therapies," noting that "His commitment to leveraging science and regulatory action to benefit patients is commendable and his contribution to cancer care will leave an indelible mark on the agency and the profession of oncology."
Diana Zuckerman, president of the National Center for Health Research, called Pazdur's departure "a huge loss for the FDA and for patients across our country," even though her organization had sometimes disagreed with his decisions. Ellen Sigal, chair and founder of Friends of Cancer Research, stated that "Rick Pazdur's evidence-based innovative track record speaks for itself."
Congressional oversight committees had already raised concerns about the FDA's direction under Makary before Pazdur's resignation. House Energy and Commerce Committee Ranking Member Frank Pallone and Senate Health, Education, Labor and Pensions Committee Ranking Member Bernie Sanders expressed significant concerns in a November 20, 2025 letter to Commissioner Makary about potential corruption issues in the Commissioner's National Priority Voucher program, highlighting bipartisan alarm about the FDA's direction under political appointees aligned with RFK Jr.'s agenda to dismantle drug safety expertise and vaccine oversight.
The FDA issued a statement respecting Pazdur's decision: "We respect Dr. Pazdur's decision to retire and honor his 26 years of distinguished service at the FDA. As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients."
Food and Drug Administration Commissioner Marty Makary came under renewed scrutiny by Trump officials amid the continued turmoil at the agency, though the White House publicly maintained confidence in his leadership. The broader context includes HHS Secretary Robert F. Kennedy Jr.'s announcement that the FDA would fire around 3,500 employees, or 19% of the agency, as part of efforts to reshape the FDA under the "Make America Healthy Again" agenda. Current and former FDA staff described the level of involvement of political officials in regulatory matters as unprecedented.