Dr. George Tidmarsh says he was targeted after questioning a new fast-track drug approval program<\/p>\n<\/h3>\n
By I. Edwards HealthDay Reporter<\/b>
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TUESDAY, Nov. 4, 2025 (HealthDay News) \u2014 The head of the U.S. Food and Drug Administration\u2019s (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.<\/p>\n
Dr. George Tidmarsh<\/a>, who joined the FDA in July, stepped down Sunday, The New York Times<\/em> reported.<\/p>\n 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.<\/p>\n The FDA confirmed that Tidmarsh\u2019s resignation was accepted, saying the leave was issued after \u201cserious concerns\u201d were reported to a federal court and the inspector general.<\/p>\n 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.<\/p>\n \u201cThe 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,\u201d Tidmarsh told The Times<\/em>.<\/p>\n \u201cThere was insufficient legal support for what they wanted to do, and so I didn\u2019t agree,” he added.<\/p>\n A lawsuit filed last week by Kevin Tang<\/a>, a major investor in Aurinia Pharmaceuticals<\/a>, accused Tidmarsh of acting vengefully against its board chairman.<\/p>\n The suit claims Tidmarsh posted negative comments online about voclosporin<\/a>, the company\u2019s lupus<\/a> drug, and tried to seek payments related to a separate business deal, The Times <\/em>said.<\/p>\n Tidmarsh strongly denied the accusations and said he had no interest in retaliating against Tang.<\/p>\n \u201cHe was irrelevant to me,\u201d Tidmarsh said, adding that he \u201cgave up everything\u201d to go into government.<\/p>\n The FDA was not named in the lawsuit.<\/p>\n 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<\/a>.<\/p>\n The program was designed to speed up approval for drugs tied to government health priorities, such as addiction treatment.<\/p>\n 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.<\/p>\n More information<\/strong><\/p>\n Learn more about the role of the U.S. Food and Drug Administration<\/a>.<\/p>\n