Video FDA’s top drug regulator placed on leave, citing ‘toxic’ work environment
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FDA places Tidmarsh on leave citing ‘personal conduct’
Dr. George Tidmarsh is the Food and Drug Administration’s top drug regulator. He was placed on leave Friday amid controversy over the drug approval process. He is accused of trying to financially harm former colleague Kevin C. Tang. Tang is a board chair and investor at Aurinia Pharmaceuticals, a company that makes voclosporin, an immunosuppressant used as a treatment for lupus nephritis, a condition of the kidneys in people who haveLupus. The suit said the post cost Aurinia about $350 million in value.
The FDA claims Tidmarsh has resigned, but Tidmarsh maintains that he was placed on leave on Friday, according to ABC News and The New York Times. He was appointed to the position in July.
Emily Hilliard, a Health and Human Services spokesperson, said in a statement that Tidmarsh was placed on leave Friday “after the Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct.”
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STAT News reported Sunday that Tidmarsh was accused of trying to financially harm former colleague Kevin C. Tang, a board chair and investor at Aurinia Pharmaceuticals. Aurinia is a Canadian company that makes voclosporin, an immunosuppressant used as a treatment for lupus nephritis, a condition of the kidneys in people who have lupus.
Aurinia filed a lawsuit against Tidmarsh for a September LinkedIn post in which he criticized voclosporin as having little benefit and “significant toxicity.” The suit said the post cost Aurinia about $350 million in value, The New York Times reported.
The lawsuit also alleges that after Tang asked Tidmarsh to resign from some companies, Tidmarsh sent messages threatening revenge against Tang and that he solicited bribes from Tang through his lawyer.
In an interview with The New York Times, Tidmarsh said he doesn’t think about Tang. “He was irrelevant to me,” he said. He denied all allegations.
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Tidmarsh said he is being pushed out because of his criticism of a new FDA process to speed up the process to review certain drugs. Tidmarsh said he voiced concern that the process might not be legal and that the reviews would bring politics into the process.
The review process normally takes months, but the new way would approve drugs within a day.
“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,” The Times reported Tidmarsh said. “There was insufficient legal support for what they wanted to do, and so I didn’t agree.”
Tidmarsh also described the FDA as a “toxic environment” because of Dr. Vinay Prasad, who oversees vaccine regulation at the FDA. Prasad was removed from his post in July but was brought back two weeks later.
F.D.A. Drug Unit Chief Resigns, and Is Sued by Drug Company
Dr. George Tidmarsh said he believed the review was opened in retaliation to concerns he raised last week about the legal basis of a new program for the rapid approval of some new drugs. A pharmaceutical company filed a lawsuit claiming that the regulator had acted vengefully against its board chairman and investor, Kevin C. Tang.
Dr. Tidmarsh said he believed the review was opened in retaliation to concerns he raised last week about the legal basis of a new program for the rapid approval of some new drugs.
Dr. Tidmarsh, a drug industry veteran who joined the agency in July, said in an interview Sunday that he believed the new program injected politics into the drug review program, superseding decisions based on science.
Late on Sunday, a pharmaceutical company lodged explosive claims against Dr. Tidmarsh in a lawsuit claiming that the regulator had acted vengefully against its board chairman and investor, Kevin C. Tang, who had previously asked Dr. Tidmarsh to leave several companies. The lawsuit claimed that Dr. Tidmarsh attempted to extort him. Dr. Tidmarsh denied the allegations, saying he had no interest in revenge against Mr. Tang, a San Diego investor.
George Tidmarsh Out at FDA
Head of FDA’s drug center George Tidmarsh is the latest member to see his name in headlines. On Friday, October 31, FDA announced that Tidm Marsh had been placed on administrative leave. This follows the filing of a lawsuit by Aurinia Pharmaceuticals, that claims that Tid marsh used his position to pursue a personal vendetta against Aurinia”s chair of the board of directors. In July, Vinay Prasad briefly lost his role at FDA before rejoining the agency as head of CBER a few weeks later. While she wasn’t a member of FDA, CDC Director Susan Monarez was fired from her post in late August. In response, the following leaders at CDC also stepped down at the same time:Dr. Debra Houry, the chief medical officer.Dr. Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases.
Over the course of 2025, the agency and its related committees have experienced a significant amount of membership turnover. While much of this was expected, due to the new administration coming in and adjusting rosters to fit its new directives, that hasn’t always been the case.
Why was Head of CBER George Tidmarsh placed on leave?
Head of FDA’s drug center George Tidmarsh is the latest member to see his name in headlines. On Friday, October 31, FDA announced that Tidmarsh had been placed on administrative leave.1 According to ABC News, Tidmarsh was considering stepping down at that time due to what he described as a “toxic environment” at the agency.
HHS spokesperson Emily Hilliard told ABC News that the decision to place Tidmarsh on leave was made after, “the Office of the General Counsel and the Office of the Inspector General were notified of serious concerns about his personal conduct.”
Following that, conflicting reports surfaced as to why Tidmarsh was out.
The Guardian reports that Tidmarsh was ousted due to concerns over his conduct.2 This follows the filing of a lawsuit by Aurinia Pharmaceuticals, that claims that Tidmarsh used his position to pursue a personal vendetta against Aurinia’s chair of the board of directors, Kevin Tang.
Tang reportedly played a key role in ousting Tidmarsh from leadership positions at various pharmaceutical companies the two previously worked together at, including La Jolla Pharmaceuticals.
Tidmarsh reportedly posted a message critical of one of Aurinia’s products on LinkedIn in September, saying it had not been shown to provide a direct clinical benefit to patients. The post was later deleted, although Aurinia did publish a response in a press release,3 stating, “Aurinia stands behind the favorable benefit/risk profile of LUPKYNIS® (voclosporin). LUPKYNIS received full approval from the FDA in January 2021 based on a large, randomized 52-week clinical study known as AURORA 1. Furthermore, the FDA approved a supplementary new drug application for the long-term use of LUPKYNIS in April 2024 based on the results of AURORA 2, which demonstrated sustained efficacy of LUPKYNIS over a three-year period, with safety comparable to AURORA 1.”
Aurinia has filed a lawsuit against FDA over the impact of the post.
Tidmarsh, however, claims that he was placed on leave after criticizing Vinay Prasad, chief medical and scientific officer at FDA, according to ABC News.1 Tidmarsh also criticized new regulatory processes at FDA designed to speed up the regulatory process.
Tidmarsh only joined FDA in July of this year. At the time, Director Makary said, “Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development—from bench to bedside. His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency.”
Also in July, Vinay Prasad briefly lost his role at FDA before rejoining the agency as head of CBER a few weeks later . There were conflicting reports as to the reason for his brief departure, although some reports suggested that he had angered right-wing influencer and Trump-ally Laura Loomer.
And while she wasn’t a member of FDA, CDC Director Susan Monarez was fired from her post in late August. In response, the following leaders at CDC also stepped down at the same time:
Dr. Debra Houry, the chief medical officer
Dr. Demetre Daskalakis, director of the National Center for Immunization and Respiratory Diseases
Dr. Daniel Jernigan, the director of the National Center for Emerging and Zoonotic Infectious Diseases
Dr. Jen Layden, director of the Office of Public Health Data, Surveillance and Technology
Sources
The top FDA vaccine official is forced out, cites RFK Jr.’s ‘misinformation and lies’
The top FDA vaccine official is forced out, cites RFK Jr.’s ‘misinformation and lies’ Dr. Peter Marks has long steered the FDA’s regulation of vaccines. Marks cited special worry about the ongoing measles outbreak in Texas, which has now grown to at least 400 cases. The abrupt departure comes as concern has been mounting among many public health experts about moves involving vaccines under Kennedy, who has questioned vaccine safety and effectiveness.”It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Marks wrote in his resignation letter to the acting commissioner of food and drugs. The announcement was met with disappointment by other doctors, including Dr. Paul Offit, a vaccine expert at the University of Pennsylvania and long-time FDA advisor. “RFK Jr. is now the wolf guarding the hen house,” Offit said.
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The Food and Drug Administration’s top vaccine regulator was forced out of the agency Friday and sharply criticized Robert F. Kennedy Jr., his boss at the Department of Health and Human Services.
“It has become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies,” Dr. Peter Marks wrote in his letter of resignation, which was obtained by NPR.
Marks has long steered the FDA’s regulation of vaccines as director of the Center for Biologics Evaluation and Research. He became especially well known during the first Trump administration for his work with Operation Warp Speed, which was credited with the fast development of COVID-19 vaccines.
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In response to Mark’s resignation, an HHS official released a statement that if Marks “does not want to get behind restoring science to its golden standard and promoting radical transparency, then he has no place at FDA under the strong leadership of Secretary Kennedy.”
The abrupt departure comes as concern has been mounting among many public health experts about moves involving vaccines under Kennedy, who has questioned vaccine safety and effectiveness. Independent federal vaccine advisory committees have been postponed and cancelled, the National Institutes of Health has terminated research on vaccines and a vaccine critic has been picked to conduct a controversial study about vaccines and autism – a link that has long been debunked.
Marks cited special worry about the ongoing measles outbreak in Texas, which has now grown to at least 400 cases. Measles can cause a long list of potentially serious complications and the vaccines provide strong, safe protection, Marks said. Kennedy has promoted alternative treatments during the Texas outbreak.
“Undermining confidence in well-established vaccines that have met the high standards for quality, safety, and effectiveness that have been in place for decades at FDA is irresponsible, detrimental to public health, and a clear danger to our nation’s health, safety. and security,” Marks wrote in his resignation letter to Sara Brenner, acting commissioner of food and drugs.
The announcement was met with disappointment by other doctors.
“In forcing Peter Marks to resign, RFK Jr. is now the wolf guarding the hen house,” said Dr. Paul Offit, a vaccine expert at the University of Pennsylvania and long-time FDA advisor who directs the Vaccine Education Center at Children’s Hospital of Philadelphia.
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It’s “a sad day for America’s children,” Offit, who sometimes disagreed with Marks, said in an email to NPR.
Marks was praised by other experts as well.
“Peter’s commitment to bringing the best science and data to the development and availability of lifesaving biomedical technologies, from gene and cell therapies to the Trump Administration’s Operation Warp Speed, has saved countless lives,” Dr. Mark McClellan, a former FDA commissioner under President George W. Bush now at Duke University wrote in a statement to NPR. “His decade-long leadership at the FDA is a big reason why the FDA is the gold standard for advancing the most innovative breakthrough medicines.”
“Peter Marks is one of the most brilliant, dedicated scientists and public servants,” wrote Dr. Ashish Jha, the dean of the Brown University School of Public Health who served as President Biden’s COVID-19 response coordinator.
Marks said he was leaving the agency with “a heavy heart.”
“I leave behind a staff of professionals who are undoubtedly the most devoted to protecting and promoting the public health of any group of people that I have encountered,” he wrote, adding that he had tried to work with Kennedy in a variety of ways.
Marks added that he hoped “the unprecedented assault on scientific truth that has adversely impacted public health in our nation comes to an end so that the citizens of our country can fully benefit from the breadth of advances in medical science.”
Edited by Jane Greenhalgh
Source: https://abcnews.go.com/US/video/fdas-top-drug-regulator-leave-citing-toxic-work-127147018