Fourth FDA Drug Chief This Year Steps Down, Raising Stability Concerns

Key TakeawaysDr. Richard Pazdur will retire after 26 years at the FDAHe was the fourth person to lead the Center for Drug Evaluation and Research (CDER)Experts warn that ongoing departures could weaken confidence in the FDA's drug-approval process.THURSDAY, Dec. 4, 2025 (HealthDay News) — The U.S. Food and Drug Administration (FDA) is facing even more leadership changes as drug regulator Dr. Richard Pazdur prepares to retire at the end of the month, the agency confirmed this week.Pazdur, who has worked at the FDA for 26 years, told senior leaders on Tuesday that he plans to step down, just weeks after taking a top position at the FDA.He is the fourth person this year to lead the FDA’s Center for Drug Evaluation and Research (CDER), which oversees most prescription medicines in the United States."We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA," a spokesperson for the agency told STAT News."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," they added.Pazdur stepped into the top drug regulator role less than a month ago, after FDA Commissioner Dr. Marty Makary urged him to take the position. But multiple people familiar with his decision said he had growing concerns about the direction the agency was planning on going.These concerns included questions about the legitimacy of a new drug review program and disagreements over Makary and Center for Biologics Evaluation and Research Director Dr. Vinay Prasad becoming involved in individual drug decisions."Really bad news here," John Maraganore, the founder of Alnylam Pharmaceuticals, posted on social media. "Rick Pazdur has been a national treasure for efforts in bringing safe and effective cancer medicines to patients."Industry leaders said these repeated leadership changes are creating uncertainty."We need organizational strength and stability at the agency," John Crowley, CEO of the biotechnology trade group BIO, told STAT News. "This constant turmoil is undermining America’s leadership in biotechnology, creating unprecedented regulatory instability and unpredictability, and risks ceding this critical sector to China."Patient advocates who sometimes disagreed with Pazdur’s decisions also said his departure is a major loss."Dr. Pazdur’s retirement is a huge loss for the FDA and for patients across our country," Diana Zuckerman, president of the National Center for Health Research, added."Many of us appreciate that he was willing to express his concerns about the FDA’s recent plans to speed up the approval process at a time when FDA had lost staff and expertise," she said.Officials said Pazdur accepted the job with the understanding that he would be protected from political influence. But reporting from multiple outlets suggests he quickly encountered problems.One issue involved a new FDA program called the Commissioner’s National Priority Voucher, designed to speed reviews for drugs tied to national priorities. Pazdur reportedly questioned whether the program was transparent or even legal.At the first vote involving a drug under the program, FDA staff were not included, raising concerns about politics shaping drug approvals.The agency has seen rapid turnover: Four FDA CDER directors in one year and other departures linked to disagreements over vaccine and drug policies. Employees have reported dropping morale, blocked transfer requests and instances of scientific opinions being overruled.More informationLearn more about what the FDA does.SOURCE: STAT News, Dec. 2, 2025.What This Means For YouChanges in FDA leadership can affect how quickly and safely new medicines reach the market..Sign up for our weekly HealthDay newsletter

Fourth FDA Drug Chief This Year Steps Down, Raising Stability Concerns

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