Top FDA Drug Regulator Pazdur to Retire Weeks Into New Role (2)

Richard Pazdur, the US Food and Drug Administration’s lead drug regulator, plans to retire from the agency only weeks after starting his new role, in a major setback for Commissioner Marty Makary.

Pazdur, a 26-year veteran of the FDA, was tapped as director of the Center for Drug Evaluation and Research, or CDER, in November. He was expected to help stabilize the agency after a period of turmoil and was viewed positively by the drug industry and its investors.

“The departure of this well-respected leader adds uncertainty and is a net negative for most of the sector,” RBC analyst Brian Abrahams wrote in a note. Pazdur’s departure “is likely to feed perceptions around internal turmoil at the FDA, adding uncertainty for the biotech sector.”

Shares of biotechnology stocks fell on Tuesday after the news. Moderna Inc. erased most of its earlier 2% gain, while Biohaven Ltd dropped as much as 3.9%. The Nasdaq Biotechnology Index — a gauge of the group — declined as much as 0.8%.

The FDA confirmed Pazdur’s intent to retire but gave no details. As the founding director of the Oncology Center of Excellence, he advanced care for countless patients and leaves a legacy of regulatory innovation that will shape the agency for years to come, FDA spokesperson Caleb Michaud said.

Staff Turmoil

Makary has been grappling with high turnover among the FDA’s top ranks. Pazdur’s appointment came after the previous top drug regulator, George Tidmarsh, resigned after being placed on administrative leave over personal conduct concerns. The division has had four directors since January.

This summer, Vinay Prasad, head of the vaccine and gene therapy division at the FDA, departed amid backlash over his role in handling safety issues related to a Sarepta Therapeutics Inc. treatment. He came back to the agency days after his exit.

The FDA also slashed headcount as part of a push from Health and Human Services Secretary Robert F. Kennedy Jr. to shrink HHS to 62,000 employees from 82,000.

The moves have made it more difficult for pharmaceutical companies to navigate drug approvals, because regulators can have different philosophies around greenlighting new medicines. The Trump administration has also taken broader steps to revamp the US approach to health care.

Pazdur’s appointment was greeted with relief by the $800 billion-a-year drug development industry. Big drug companies have worked with him for years on dozens upon dozens of cancer drug approvals. He was the architect behind the agency’s speedier reviews a decade ago, especially for newer cancer cocktails under the division he led.

Pazdur initially declined to take the position as CDER director before ultimately deciding to accept it, according to people familiar with the matter who were not authorized to publicly discuss private details.

The retirement was first reported by Stat.

(Adds analyst comment in in the third paragraph, FDA statement in the fifth paragraph.)

--With assistance from Angel Adegbesan and Gerry Smith.

To contact the reporters on this story:
Rachel Cohrs Zhang in Washington at rzhang698@bloomberg.net;
Jessica Nix in New York at jnix20@bloomberg.net

To contact the editors responsible for this story:
Cynthia Koons at ckoons@bloomberg.net

Kelly Gilblom, Michelle Fay Cortez

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