How will Dr. Pazdur’s New Role Affect the Future of FDA Advisory Committees?
Among all the changes at the FDA in 2025, one recent shift that has drawn high praise from the medical community is the appointment of Dr. Richard Pazdur as director of the Center for Drug Evaluation and Research (CDER).
A 26-year FDA veteran, Dr. Pazdur is known as an innovator for driving the development of novel approaches to speed drug reviews.
In a statement issued November 11, Ellen Sigal, PhD, chair and founder of Friends of Cancer Research, said, “Rick Pazdur has been a tireless public servant and one of the most trusted leaders in biomedical innovation. His decades of dedication to patients, science, and collaboration across sectors have strengthened FDA’s role as a global standard-bearer for cancer care and therapeutic development.
One interesting aspect of Dr. Pazdur’s appointment will be how CDER uses FDA Advisory Committees (AdComs) in 2026 and beyond. During his 20-year tenure (2005-2025) as the director of the FDA’s Oncology Center of Excellence, he frequently convened FDA AdComs to solicit valuable external expert advice on new drug applications. He also used these meetings of clinical experts to seek advice and foster discussion on a myriad of topics, from discussing innovative trial designs, cutting-edge drug targets, and tumor-agnostic biomarkers, to effective ways to confirm clinical benefit after expedited drug approvals.
This approach would appear to contrast with the significant decrease in the number of AdComs held across the Agency in 2025 and FDA Commissioner Dr. Marty Makary’s recent comments, calling AdComs “bureaucratic, long, often conflicted, and very expensive.”
But could there be common ground? For many years there have been calls for FDA AdCom reform. Former FDA Commissioner Dr. Robert Califf sought more targeted meetings to provide scientific advice earlier in the development process. Some also have expressed concerns about whether the current conflict of interest rules inadvertently exclude top experts, while others seek greater diversity on the panels.
And then there is the question of when and how voting should be used. Should committee members vote to support or oppose a drug’s approval, and if so, should the Agency be bound by those recommendations? Dr. Pazder has often said the experts’ discussion is more meaningful than their vote, but many in the public and media appreciate the clarity that voting provides.
A positive outcome in this year of change could be a renewed discussion of how best to use AdComs to assist the Agency and engage experts and the public in the drug review and approval process.
Dr. Sigal said, “At a time when the agency faces both extraordinary opportunity and complexity, Rick’s steady leadership and commitment to scientific integrity make him exactly the right person to lead CDER.”
And who better to drive improvement to the AdCom process than the leader behind the past 20 years of ODACS? What reforms would you like to see in the FDA Advisory Committee process?
Greg Connel
Executive Director
With 30 years of communications strategy and training experience, Greg leads the HCG ProEd Regulatory team and provides overall strategic direction and speaker coaching for many of our AdCom clients. Greg has prepared teams for more than 100 FDA Advisory Committee meetings.