Top FDA Drug Regulator Discloses Why He Resigned

‘Promises made, promises not kept,’ Dr. Richard Pazdur said.

The Food and Drug Administration in White Oak, Md., on June 5, 2023.Madalina Vasiliu/The Epoch Times

A doctor who until recently was one of the most senior officials at the Food and Drug Administration (FDA) said in his first public comments since his resignation that he left because promises that were made to him had been broken.

“Promises made, promises not kept,” said Dr. Richard Pazdur, who served as director of the FDA’s Center for Drug Evaluation and Research for several weeks in late 2025.

Speaking at a forum in California on Jan. 12, he declined to detail what those promises were or who made them.

But Pazdur said he took offense at what he described as disrespect toward FDA staffers by Dr. Vinay Prasad, who heads the FDA’s Center for Biologics Evaluation and Research.

Pazdur pointed in part to an email Prasad wrote that disclosed that the FDA had determined that some children died because of COVID-19 vaccination. In the Nov. 28, 2025, missive, Prasad also told employees that leaking documents to the media was unethical and illegal, that the FDA was adopting new guidelines for vaccines, and that staffers who did not agree with “the core principles and operating principles” should submit their resignation.

“That is not how you treat people,” Pazdur said on Jan. 12. “It is not appropriate.”

Pazdur, who joined the FDA in 2003, said that and other incidents caused him to ask himself whether he wanted to work in such an environment.

He stepped down shortly after.

Prasad did not respond to a request for comment.

The FDA appointed Dr. Tracy Beth Hoeg, who has worked closely with Prasad in the past, to head the Center for Drug Evaluation and Research on an interim basis.

Pazdur also took aim at a new pilot program started by FDA Commissioner Dr. Marty Makary that awards companies vouchers to accelerate the time it takes to review their products.

Pazdur said his issues with the program included closed-door meetings that do not include all reviewers or the company that makes the product. He also said it was unclear to him who was signing off on decisions and said officials had introduced new rules for the process.

“It’s the proverbial building a plane while you’re flying it, so to speak,” he said.

Andrew Nixon, a spokesman for the Department of Health and Human Services, the FDA’s parent agency, told The Epoch Times in an email that most of the vouchers have been nominated by reviewers and that a committee led by the FDA’s deputy chief medical officer selects from among those nominations.

“Every FDA drug approval and rejection decision under Dr. Makary’s leadership has been consistent with the approved/reject recommendation of the review team of career scientists,” Nixon said.

He also said that the standards “are the same as with all drugs, and the committee reserves the right to extend the review time as needed.”