FDA Leadership Shakeup: Pazdur Takes Helm at CDER Amid Agency Turmoil

In a significant development for the pharmaceutical industry, Dr. Richard Pazdur has been appointed as the new head of the FDA's Center for Drug Evaluation and Research (CDER). This move comes amid a period of unprecedented turnover and internal strife at the agency, particularly between CDER and the Center for Biologics Evaluation and Research (CBER).

Pazdur's Appointment: A Stabilizing Force

Dr. Pazdur, a 26-year FDA veteran and founder of the agency's Oncology Center of Excellence, is widely regarded as an "ideal fit" to bring stability to CDER. His appointment follows a tumultuous year that saw four different leaders at the helm of the agency's most powerful regulatory division.

Peter Pitts, former FDA associate commissioner for external relations, described Pazdur as a "mensch" and a "caring guy," highlighting the respect he commands within the agency. RBC Capital Markets analyst Brian Abrahams echoed this sentiment, calling Pazdur a "well known and highly respected leader" who has a track record of balancing expedited cancer drug approvals with ensuring the withdrawal of those that fail confirmatory studies.

Tensions with CBER and Internal Challenges

The appointment comes against a backdrop of reported conflicts between CDER and CBER, particularly involving CBER director Dr. Vinay Prasad. Prasad, a former social media personality, has been critical of Pazdur's work in oncology, stating in a blog post that Pazdur "has done a catastrophically bad job."

These tensions culminated in the recent resignation of former CDER director George Tidmarsh amid a probe into his "personal conduct." Tidmarsh reportedly found the FDA to be a toxic work environment, a situation he attributed to Prasad.

Industry experts are closely watching how Pazdur will navigate these internal challenges. Pitts stated, "The first time [Prasad] tries to supersede Dr. Pazdur's authority, there will be hell to pay and resignations to be handed in."

Implications for Drug Development and Approval

Pazdur's leadership is expected to align with FDA Commissioner Marty Makary's goals, particularly in embracing innovative approaches to drug approval. Abrahams noted that Pazdur's work at the Oncology Drugs Advisory Committee aligns with the agency's new focus on accelerated approval processes.

Ellen Sigal, chairperson and founder of Friends of Cancer Research, emphasized that Pazdur's "expertise and creativity" could make a particular difference in rare diseases, where "innovative trial designs and data strategies are essential to delivering progress for patients."

As the pharmaceutical industry watches these developments unfold, Pazdur's tenure at CDER is poised to have far-reaching implications for drug development, approval processes, and the overall regulatory landscape in the coming years.