Longtime Oncology Official at FDA Tapped as Top Drug Regulator

 Longtime FDA innovation specialist Richard Pazdur, MD, has been named director of the agency's Center for Drug Evaluation and Research (CDER), the FDA announced Tuesday.

A 26-year FDA scientist and administrator, Pazdur has headed the agency's Oncology Center of Excellence since its creation in 2017, coordinating expedited review of drugs and devices. During his tenure, the agency launched multiple initiatives to streamline oncology drug approvals, access, and labeling.

"Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process," FDA Commissioner Marty Makary, MD, MPH, said in a statement. "He has a track record of success and is an impressive forward-thinking scientist."

"I'm honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms," said Pazdur. "I look forward to working closely with Dr. Makary and the medical experts he's assembled to help our country reach its peak in drug development."

Pazdur has been a fixture over the years at meetings of the Oncologic Drugs Advisory Committee, offering the agency's perspective to panelists and his candid take on drug applications. At one meeting in 2023, Pazdur told committee members reviewing data on belinostat (Beleodaq) in peripheral T-cell lymphoma that "the development of this drug has been, for lack of a better word and not to be overly critical, let's just say suboptimal, and I'm being kind by using suboptimal rather than other words here."

Prior to joining the FDA in 1999, Pazdur was a faculty member and respected gastrointestinal cancer researcher and clinician at the University of Texas MD Anderson Cancer Center in Houston. He accepted the CDER position after multiple news outlets reported last week that he had turned down the job.

He succeeds George Tidmarsh, MD, PhD, who resigned earlier this month amid controversy after less than 4 months as head of CDER.

"Rick Pazdur has been a tireless public servant and one of the most trusted leaders in biomedical innovation," said Ellen Sigal, PhD, the chair and founder of Friends of Cancer Research, said in a statement.

"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," Sigal continued. "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."

https://www.medpagetoday.com/publichealthpolicy/fdageneral/118463