FDA’s top drug officer set to exit, weeks into new role
By Sarah Owermohle, Adam Cancryn, Ben Tinker, Meg Tirrell, CNN
(CNN) — The US Food and Drug Administration’s longtime oncology chief has filed to retire from the agency just weeks after he was chosen to lead the FDA’s drug division, according to four people familiar with his decision.
Dr. Richard Pazdur was named director of the Center for Drug Evaluation and Research on November 11, taking leadership of the FDA’s largest division after its former director, Dr. George Tidmarsh, abruptly resigned.
Pazdur’s decision was first reported by Stat News.
It represents a remarkable reversal from just weeks ago, when FDA Commissioner Dr. Marty Makary announced his appointment in a laudatory statement that described him as a “true regulatory innovator” and “an impressive forward-thinking scientist.”
Both Makary and and Dr. Vinay Prasad, chief of the agency’s biologics division, later heaped praise on Pazdur in an FDA podcast, with Prasad saying the two had “been working hand in glove” for several months.
Yet behind the scenes, there had been signs that the new arrangement might not play out as smoothly as the agency’s leaders hoped.
Pazdur’s exit comes amid frustration with Makary and Prasad, according to three people familiar with the situation.
Those people said Pazdur had balked at what he saw as political interference in his division, which oversees most prescription drugs, over-the-counter medicines and commonly used products such as sunscreen and toothpaste.
Pazdur had initially turned down Makary’s offer to become top drug regulator over concerns that he would clash more directly with Prasad, who had openly criticized him in a blog post years prior for having “done a catastrophically bad job” at the FDA, two people familiar with the matter said.
Makary later pressed Pazdur to reconsider, at one point traveling to his house to discuss the job and assure Pazdur that he would retain full autonomy in the role, the people said.
Pazdur ultimately accepted. But he began telegraphing his unhappiness within a matter of days, the people said, raising concerns in particular about a plan pushed by Makary to expedite certain drug decisions and musing to associates about resigning or returning to his prior role.
On Tuesday, Pazdur informed colleagues within the agency that he planned to retire at the end of the month, in a sign that he viewed the current situation as unsalvageable.
Pazdur arrived at the FDA in 1999 from the University of Texas MD Anderson Cancer Center in Houston, to lead its Division of Oncology Drug Products.
In 2017, he became founding director of the Oncology Center of Excellence, tasked with advancing innovations in cancer treatments. He has transformed how the agency regulates cancer drugs, helping forge faster pathways to get them to market.
Pazdur’s retirement would mean vacancies at both the top of the drug division and the oncology center.
“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an agency spokesperson said Tuesday. “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. His leadership, vision, and dedication will continue to shape the FDA for years to come.”
Pazdur’s appointment to lead the Center for Drug Evaluation and Research was seen as a move toward stability for an agency rocked with chaos among its top personnel.
Pazdur was “an optimal fit,” wrote Brian Abrahams, who closely follows the FDA as a biotechnology analyst for Wall Street firm RBC Capital Markets, in a research note the day he was appointed. Abrahams called Pazdur “arguably the most qualified candidate in the entire healthcare ecosystem for this role.”
Stocks of biotechnology companies, including makers of cancer drugs, dropped Tuesday morning after the news of Pazdur’s looming departure.
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