Pazdur takes helm at CDER after Tidmarsh departure

The US Food and Drug Administration (FDA) has named Richard Pazdur to lead its drug center, just over a week after the departure of its former director, George Tidmarsh, who resigned amid an investigation into his alleged conduct involving a social media post targeting a product made by a company chaired by a former business associate.

Pazdur, 26-year veteran of the agency and the first director of its Oncology Center of Excellence (OCE), will lead the agency’s Center for Drug Evaluation and Research, FDA announced on Tuesday, following reports Pazdur had turned down the job the week before.

“Dr. Pazdur is a true regulatory innovator who will help guide our broader agenda to modernize the agency and streamline the approval process,” said FDA Commissioner Marty Makary in a statement. “He has a track record of success and is an impressive forward-thinking scientist.”

Last week, The Pink Sheet reported that Pazdur had been offered the job but initially declined. His appointment comes after former pharma executive George Tidmarsh resigned from the position after making a LinkedIn post in September stating that FDA would be evaluating surrogate endpoints and that some companies had failed to conduct trials to demonstrate the benefits of their products on hard clinical endpoints. In particular, he singled out Aurinia Pharmaceuticals’ kidney drug Lupkynis (voclosporin). Soon thereafter, the company's stock took a 20% tumble, and while Tidmarsh deleted his post and later said that the post reflected his own opinion and not those of the agency, the damage was done.

Tidmarsh was placed on administrative leave while an internal investigation into a complaint against him, lodged by Kevin Tang, a San Diego-based healthcare investor and board chair of Aurinia, was conducted. He ultimately resigned shortly before Aurinia announced that it was suing him.

Pazdur takes the helm of the agency’s largest center at a tumultuous time. Earlier this year, the Trump administration’s reduction-in-force efforts led to thousands of layoffs across FDA, and the agency has witnessed the departure of many of its long-time leaders.

“I’m honored to lead CDER at a time when the FDA is achieving long-sought regulatory reforms,” said Pazdur in a statement. “I look forward to working closely with Dr. Makary and the medical experts he’s assembled to help our country reach its peak in drug development.”

Before his time at FDA, Pazdur also taught medicine at the University of Texas M.D. Anderson Cancer Center and has published more than 800 articles, book chapters, and abstracts, as well as two medical oncology textbooks.

FDA

Pazdur takes helm at CDER after Tidmarsh departure

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