WASHINGTON — Top drug regulator Richard Pazdur has filed papers to retire from the Food and Drug Administration at the end of this month, adding to the turmoil atop the agency.
Pazdur informed leaders at the FDA’s drug center of his intention to leave the agency at a meeting on Tuesday, according to two agency sources familiar with the matter. The move comes less than a month after he took the role of top drug regulator at the urging of FDA Commissioner Marty Makary.
A spokesperson for the FDA confirmed the news and said Pazdur’s decision is final. Pazdur did not respond to a request for comment.
“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” the FDA spokesperson told STAT. “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.”
Pazdur is the fourth person to lead the Center for Drug Evaluation and Research this year. The previous director, George Tidmarsh, left the agency in November amid allegations that he used his position to advance a personal vendetta against a business associate, and amid conflict with Center for Biologics Evaluation and Research Director Vinay Prasad.
Three sources close to Pazdur told STAT that concerns about the legality of a new drug review program, Makary and Prasad inserting themselves into drug review decisions, and Makary’s efforts to handpick hires for CDER contributed to Pazdur’s decision to leave.
The elevation of Pazdur, a longtime FDA staffer who was previously the director of the cancer center, was intended to stabilize the agency. Biotech stocks gave up gains after STAT reported on Pazdur’s plan, with the S&P Biotech ETF sliding 1%.
“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.”
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Even patient advocates who sometimes disagreed with Pazdur’s decisions to approve certain cancer drugs expressed dismay at the news.
“Dr. Pazdur’s retirement is a huge loss for the FDA and for patients across our country,” said Diana Zuckerman, president of the National Center for Health Research. “Many of us appreciate that he was willing to express his concerns about FDA’s recent plans to speed up the approval process at a time when FDA had lost staff and expertise.”
Pazdur took the job on assurances that he would be protected from political influence, sources close to him previously told STAT. Political pressure has increasingly affected science at the agency, especially for products of particular interest to health secretary Robert F. Kennedy Jr., like vaccines, antidepressants, and autism treatments.
But it seems that Pazdur ran into issues almost immediately. The Washington Post reported that Pazdur raised concerns about a new program spearheaded by Makary to offer expedited review to drugs that align with national priorities. He noted that the program, called the Commissioner’s National Priority Voucher, was not transparent and could be illegal. Tidmarsh also raised concerns about the program on his way out of the FDA.
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Experts told STAT that the personnel drama at the FDA threatens to undermine the credibility of the agency, which is charged with protecting and promoting public health.
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