• Posted November 4, 2025

Top FDA Drug Chief Resigns While Under Investigation

The head of the U.S. Food and Drug Administration’s (FDA) drug division has resigned while under internal investigation, saying he was pushed out after raising concerns about how the agency planned to fast-track some new drugs.

Dr. George Tidmarsh, who joined the FDA in July, stepped down Sunday, The New York Times reported. 

His resignation came just days after he was placed on administrative leave while federal officials investigated accusations connected to a lawsuit involving a drug company and one of its investors.

The FDA confirmed that Tidmarsh’s resignation was accepted, saying the leave was issued after “serious concerns” were reported to a federal court and the inspector general.

Tidmarsh, however, said he believes the investigation began after he questioned the legality of a new program that would approve some drugs much faster than usual. He said the plan could allow political priorities to outweigh actual science.

“The effort was going to basically change the entire paradigm of the legal underpinnings of drug approvals that have for decades supported the actions on the safety and effectiveness of drugs,” Tidmarsh told The Times.

“There was insufficient legal support for what they wanted to do, and so I didn’t agree," he added.

A lawsuit filed last week by Kevin Tang, a major investor in Aurinia Pharmaceuticals, accused Tidmarsh of acting vengefully against its board chairman.

The suit claims Tidmarsh posted negative comments online about voclosporin, the company’s lupus drug, and tried to seek payments related to a separate business deal, The Times said.

Tidmarsh strongly denied the accusations and said he had no interest in retaliating against Tang.

“He was irrelevant to me,” Tidmarsh said, adding that he “gave up everything” to go into government.

The FDA was not named in the lawsuit.

Tidmarsh said tensions grew in mid-October when FDA officials met to approve the first drug under a new rapid-review program created by Health Secretary Robert F. Kennedy Jr. 

The program was designed to speed up approval for drugs tied to government health priorities, such as addiction treatment.

Tidmarsh said the program asked staff to make decisions in a single day, even though drug reviews normally take months and include formal scientific debates.

More information

Learn more about the role of the U.S. Food and Drug Administration.

SOURCE: The New York Times, Nov. 2, 2025