Dr. George Tidmarsh doesn’t have an established track record in government service. But his history as a physician, academic, biotech entrepreneur and importantly, his blossoming ties to the FDA’s new band of leadership, were enough to land him a top post at the agency.
The FDA announced this week that Tidmarsh will be the new director of the Center for Drug Evaluation and Research, the agency’s main drug review division. The high-profile and multi-faceted post can lend itself to controversial decision-making.
“On any given day [CDER directors are] balancing the workflows of dozens of INDs, NDAs and ANDAs, driving policy for things like real-world evidence and adaptive trials, and then turning around to co-chair international harmonization meetings,” said Aman Khera, president of TOPRA, The Organization for Professionals in Regulatory Affairs, in an email. “The role is part scientist, part CEO, part diplomat.”
"There’s a real thirst for forward-looking guidance on cutting-edge modalities and a willingness from CDER."
Aman Khera
President, TOPRA, The Organization for Professionals in Regulatory Affairs
Tidmarsh replaces Dr. Jennifer Corrigan-Curay, who took over as acting director after Dr. Patrizia Cavazzoni vacated the post along with several other FDA leaders just before President Donald Trump took office this year. Tidmarsh is coming into the agency as it grapples with job cuts that initially stranded 3,500 staffers before some employees were asked to return. At the same time, the FDA is pushing to modernize its review process through AI and other new policies.
“There’s relentless pressure to maintain review speed under flat or shrinking budgets, without cutting corners on safety,” Khera said.
While Tidmarsh’s biotech background has triggered age-old concerns over the “revolving door” between the FDA and pharma, “physician-scientists or seasoned life-sciences executives” are typically tapped to helm CDER, Khera said.
“That bench-to-bedside trajectory, plus proven operational skills managing large, multidisciplinary teams, ensure they can translate cutting-edge science into efficient regulatory pathways,” she said.
During a transition for the agency that’s triggered uncertainty for pharma, the industry is now craving predictability.
“[Pharma companies] want clear, consistent review timelines and transparent review criteria so they can plan development programs with confidence,” Khera explained. “Beyond that, there’s a real thirst for forward-looking guidance on cutting-edge modalities and a willingness from CDER to pilot new regulatory-science approaches.”
How effectively will Tidmarsh deliver on those expectations? A look at his career and past public comments offers clues.
His past in academia
Tidmarsh has long been associated with Stanford University, where he studied cancer biology and now serves as adjunct faculty of pediatrics and neonatology. Both FDA Commissioner Dr. Martin Makary and NIH director Dr. Jay Bhattacharya hailed from Stanford as well, and in a wide-ranging conversation with Makary on Monday, Tidmarsh called the university his “home” since he arrived there as an undergraduate in 1979.
Tidmarsh teaches clinical research and development, according to Stanford’s faculty bio, but “[h]e focuses most of his efforts currently on improving scientific data integrity in published literature.”
Tidmarsh’s connection to published literature has been controversial. He contributed to the Journal of the Academy of Public Health founded this year by Bhattacharya — which Bloomberg called a “fringe medical journal” connected with a conservative nonprofit and several other appointees to top government positions. The journal has been quiet since May.
His biotech pursuits
Tidmarsh is also known as a serial entrepreneur in biopharma. His first known founding effort was Threshold Pharmaceuticals, where he served as CEO from 2001 to 2006, according to LinkedIn, and which merged with Molecular Templates in 2017.
Tidmarsh was the founder of Horizon Therapeutics in 2005, serving as CEO until 2008. His tenure there was defined by an approval for a rheumatoid arthritis drug Duexis that was later subject to pricing controversies. Horizon, which focused on rare diseases after Tidmarsh’s departure, was sold to Amgen for $28 billion in 2022.
He was also CEO of La Jolla Pharmaceutical Company from 2011 to 2019, leading the development of a blood pressure drug that failed to meet sales expectations.
Tidmarsh is credited with bringing seven drugs to the market.
His latest role was at Revelation Biosciences’ board of directors, which he stepped down from in May, informing fellow members that he “will be working closely with U.S. governmental agencies” as a Stanford faculty member that could pose a conflict of interest.
Tidmarsh said his appointment to CDER came out of “proximity” to Makary and Bhattacharya, particularly during a dinner the three men shared in Washington, D.C., when Bhattacharya was nominated for the NIH role.
Public health critiques
Like many of the FDA’s new leaders, Tidmarsh has openly criticized public health policy, particularly the government’s handling of COVID-19.
During an interview on a podcast called “Derate the Hate” last year, Tidmarsh lambasted the lack of “academic freedom” in public health during the pandemic.
“Typically, in academia there is a good debate that occurs over time to at least attempt to come to the right answer. That got short-cut in the pandemic,” Tidmarsh told host Wilk Wilkinson, who pegged himself as a “staunch conservative” during the episode. “Not only did it not happen, but it turned into political polarization.”
Tidmarsh also hinted at his support for the theory that the novel coronavirus originated from a lab in Wuhan, a belief that has permeated right-leaning circles for years, and suggested that the NIH’s “guilt” over its role in the pandemic could have contributed to its policy-making approach.
“I’m not saying I have any evidence other than what’s there publicly, but I can say that there clearly was some link between the NIH and the research that was done in Wuhan,” Tidmarsh said. “And if you’re worried you contributed to something that’s going to be horrible … you don’t want a lot of debate.”
At the same time, Tidmarsh was sympathetic to government leaders, noting that regardless of what decisions were made, he understood why agencies had to stick to their guns.
“Once they decided on those rules, you can’t fault them for being draconian about enforcing those,” he said. “That’s a principle within public health and infectious diseases … because if you let it leak a little bit, it goes everywhere.”
But an op-ed Tidmarsh penned this year also heaped criticisms onto former CBER director, Dr. Peter Marks, for his handling of approvals that included COVID vaccines, Biogen and Eisai’s Alzheimer’s disease treatment Aduhelm and Sarepta Therapeutics’ gene therapy Elevidys, which was just pulled from the market this week following several patient deaths.
How he’ll lead at FDA
Despite his industry and academic bona fides, Tidmarsh has some leadership skills to learn, he admitted to Makary this week.
“The No. 1 thing I need to work on is motivating people,” he said. “I started companies, but I usually turned it over to someone else when it got to a certain size. La Jolla was probably the largest at about 600 people. Maybe the principles are the same, but … I have to be comfortable in that larger role.”
During his sit-down with Makary, Tidmarsh praised the FDA and its staff, and echoed the commissioner’s mission to “modernize” the agency, noting that reform efforts are not a criticism of past performance.
“It’s a wonderful agency,” he said. “My experience has been incredibly positive from the sponsor side, but I’ve also seen growth and improvement, and I think there’s more to grow and improve.”
In particular, Tidmarsh said he wants to boost efficiency in reviews and establish more consistency in communication to sponsors working in the “same disease state.”
That consistency in how the FDA handles reviews, especially as it integrates new technologies, is one of the chief issues facing the agency, Khera said.
“Integrating AI and real-world data into decision-making looks promising but risks inconsistent application across review divisions,” she said.
And while the conversation with Makary didn’t touch on lingering challenges related to public trust in health agencies, Tidmarsh indicated in his interview with Wilkinson that politics should be removed from public policy decisions.
“We need to go back to a neutrality where these institutions are very revered, they are depended upon by all of us, they do good, but they are apolitical,” he said.
