By Padmanabhan Ananthan and Ahmed Aboulenein WASHINGTON (Reuters) -The U.S. Food and Drug Administration said on Tuesday it appointed the agency’s veteran oncology chief Richard Pazdur to oversee the department that reviews of new medicines, installing one of its few remaining experienced regulators during sweeping leadership changes under Health Secretary Robert F. Kennedy Jr. Pazdur, […]
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FDA appoints veteran oncology chief Pazdur to lead drug center
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By Padmanabhan Ananthan and Ahmed Aboulenein
WASHINGTON (Reuters) -The U.S. Food and Drug Administration said on Tuesday it appointed the agency’s veteran oncology chief Richard Pazdur to oversee the department that reviews of new medicines, installing one of its few remaining experienced regulators during sweeping leadership changes under Health Secretary Robert F. Kennedy Jr.
Pazdur, who leads the FDA’s Oncology Center of Excellence, replaces George Tidmarsh, who resigned earlier this month amid serious concerns about his personal conduct, a Department of Health and Human Services spokesperson told Reuters.
Pazdur joined the FDA in 1999 and was named director of the Office of Oncology Drug Products in 2005.
He has been credited with speeding the review process for dozens of cancer drugs and is known as much for his advocacy, driven in part by the death of his wife from ovarian cancer, as for his regulatory expertise.
Earlier this year, he received the American Association for Cancer Research 2025 Enduring Impact Award for Transformative Service to Cancer Science and Medicine.
“Rick is an outstanding regulator and a scholar in clinical evidence and medicine,” said Dr. Robert Califf, who twice served as FDA commissioner. “His creative thinking and empathy for patients have shaped FDA’s recent history. I hope he will be given leeway to do what’s right.”
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Pazdur will now oversee one of the FDA’s largest and most important divisions, which regulates over-the-counter and most prescription drugs.
His appointment comes during significant leadership shakeups under Kennedy, who ousted longtime FDA vaccine chief Peter Marks and gene-therapy head Nicole Verdun.
“Other than (Center for Devices and Radiological Health Director) Michelle Tarver, Rick is the only one left with a track record as a regulator. He understands regulations and how they work,” said Califf, under whom Pazdur served twice.
In an interview with the New York Times earlier this month, Tidmarsh said he was placed on administrative leave after raising concerns about the legal basis of a new program for the rapid approval of some drugs.
Tidmarsh is also facing a lawsuit from Canadian drugmaker Aurinia Pharmaceuticals, which accuses him of soliciting a bribe and damaging the company’s stock with false statements as part of an alleged revenge campaign against a former colleague.
Pazdur will continue to lead the oncology center until a successor is named, the FDA said.
His appointment was applauded by cancer advocacy groups.
“Rick Pazdur has been a tireless public servant and one of the most trusted leaders in biomedical innovation,” said Ellen Sigal, chair and founder of Friends of Cancer Research.
“At a time when the agency faces extraordinary opportunity and complexity, Rick’s steady leadership and commitment to scientific integrity make him exactly the right person to lead CDER.”
(Reporting by Padmanabhan Ananthan in Bengaluru and Ahmed Aboulenein in Washington; Additional Reporting by Julie Steenhuysen in Chicago; Editing by Alan Barona and Bill Berkrot)