Also, Richard Pazdur, the United States’ chief drug regulator, has signaled his readiness for retirement. This follows just a few weeks after his appointment. If his departure does prove true, it comes amid deepening leadership chaos at the U.S. Food and Drug Administration (FDA). He would be the fourth permanent head of FDA’s Center for Drug Evaluation and Research (CDER) this calendar year.
Pazdur, too, originally rejected the position, reluctantly taking it up with encouragement from FDA Commissioner Marty Makary. His appointment was widely seen as a principle meant to steer the F.D.A. through the launch of a new rapid approval program designed to fast-track drug assessments. According to reports, there has been a lack of planning to roll out this new initiative successfully.
The recent developments surrounding Pazdur’s potential retirement have been confirmed by Emily Hilliard, a spokesperson for the U.S. Department of Health and Human Services (HHS). She stated, “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA.”
He had asked for retirement, but submitting the paperwork to the U.S. government is often a lengthy, bureaucratic process. Sadly, that’s not done overnight. Pazdur could have agreed to voluntarily go this route, observers say, but he likely improved his options by submitting his retirement papers, given the rising internal turmoil.
Pazdur’s battles with other regulators have increased the discord inside the FDA. These clashes are focused on a new system designed to make regulatory decision-making more efficient. These one-day meetings have worried advocates about the agency’s capacity to take a deep dive review of applications and properly document the justification for their decisions.
Janet Woodcock, a prominent figure within the FDA, expressed concern over Pazdur’s potential exit, stating, “Who else is left? He was the one person who was identified.” She further emphasized the challenges in finding a suitable replacement during this turbulent period: “There’s been a lot of departures, and it would be hard to find a substitute now with all this turmoil.”
Pazdur’s conflicts extend far past the inner workings of CDER. He has allegedly already butted heads with Vinay Prasad, the director of the Center for Biologics Evaluation and Research (CBER), and currently the chief medical and scientific officer at the FDA. Woodcock elaborated on the FDA’s approach to decision-making under these new systems, comparing it to a Roman spectacle: “The plan was that Dr. Prasad and company would have a panel and just go ahead and say ‘yay’ or ‘nay’, like the Romans at the Coliseum, thumbs up or down.”
While Woodcock acknowledged that Pazdur might retire, she cautioned that his departure is not yet certain: “Maybe he will retire, but I don’t think it’s a slam dunk yet.” The question mark over his possible exit only complicates a complicated and fraught environment at the FDA even further.
If Pazdur were to step down, it would be very hard to find a replacement. The agency is now caught between deepening political headwinds and an increasingly deadly internal war. His possible departure looms large as a personal decision of great consequence. It highlights the more systemic challenges the FDA faces as it contends with a major leadership vacuum.
