The US Food and Drug Administration’s longtime oncology chief has filed to retire from the company simply weeks after he was chosen to lead the FDA’s drug division, in accordance to 4 folks aware of his choice.
Dr. Richard Pazdur was named director of the Center for Drug Evaluation and Research on November 11, taking management of the FDA’s largest division after its former director, Dr. George Tidmarsh, abruptly resigned.
Pazdur’s choice was first reported by Stat News.
It represents a outstanding reversal from simply weeks in the past, when FDA Commissioner Dr. Marty Makary introduced 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 company’s biologics division, later heaped reward on Pazdur in an FDA podcast, with Prasad saying the 2 had “been working hand in glove” for a number of months.
Yet behind the scenes, there had been indicators that the new association may not play out as easily because the company’s leaders hoped.
Pazdur’s exit comes amid frustration with Makary and Prasad, in accordance to three folks aware of the state of affairs.
Those folks mentioned Pazdur had balked at what he noticed as political interference in his division, which oversees most pharmaceuticals, over-the-counter medicines and generally used merchandise equivalent to sunscreen and toothpaste.
Pazdur had initially turned down Makary’s supply to grow to be top drug regulator over considerations that he would conflict extra immediately with Prasad, who had overtly criticized him in a blog post years prior for having “done a catastrophically bad job” on the FDA, two folks aware of the matter mentioned.
Makary later pressed Pazdur to rethink, at one level touring to his home to talk about the job and guarantee Pazdur that he would retain full autonomy within the role, the folks mentioned.
Pazdur finally accepted. But he started telegraphing his unhappiness inside a matter of days, the folks mentioned, elevating considerations particularly a few plan pushed by Makary to expedite sure drug choices and musing to associates about resigning or returning to his prior role.
On Tuesday, Pazdur knowledgeable colleagues throughout the company that he deliberate to retire on the finish of the month, in an indication that he seen the present state of affairs as unsalvageable.
Pazdur arrived on 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 turned founding director of the Oncology Center of Excellence, tasked with advancing improvements in most cancers therapies. He has reworked how the company regulates most cancers medicine, serving to forge quicker pathways to get them to market.
Pazdur’s retirement would imply vacancies at each the top of the drug division and the oncology heart.
“We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an company spokesperson mentioned 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 transfer towards stability for an company rocked with chaos amongst its top personnel.
Pazdur was “an optimal fit,” wrote Brian Abrahams, who carefully follows the FDA as a biotechnology analyst for Wall Street agency RBC Capital Markets, in a analysis be aware the day he was appointed. Abrahams known as Pazdur “arguably the most qualified candidate in the entire healthcare ecosystem for this role.”
Stocks of biotechnology firms, together with makers of most cancers medicine, dropped Tuesday morning after the information of Pazdur’s looming departure.