The Food and Drug Administration commissioner, Marty Makary, has selected George Tidmarsh, a former biotech executive and Stanford-affiliated pediatrician, to lead the agency’s drug regulatory arm, according to a source familiar with the matter.
The appointment of Tidmarsh to the position of director at the Center for Drug Evaluation and Research (CDER) could be formally announced as early as Monday, said the individual, who requested anonymity due to the non-public nature of the decision.
At 65, Tidmarsh is poised to take charge of one of the FDA’s largest divisions, overseeing a workforce of approximately 5,700 employees. CDER is responsible for evaluating the majority of new drug applications. The post became available following the departure of acting director Jacqueline Corrigan-Curay, who recently stepped down from the role.
Tidmarsh brings a wealth of industry experience, having contributed to the development of several FDA-approved therapies. His track record is expected to reassure pharmaceutical stakeholders, particularly at a time when the sector faces mounting pressure from the Trump administration to rein in prices and repatriate drug manufacturing.
Among the key challenges Tidmarsh will inherit is the controversial use of accelerated drug approvals — a mechanism that has seen a notable uptick and drawn criticism for sometimes allowing unproven treatments to remain on the market. Proponents, however, argue the system delivers potentially life-saving therapies faster to patients with serious conditions.
Tidmarsh is also expected to play a central role in reevaluating the FDA’s oversight of prescription drug advertising. Health Secretary Robert F. Kennedy Jr., a longstanding opponent of direct-to-consumer pharmaceutical ads, has pushed for reform in this area, and Commissioner Makary has signalled that the agency’s stance is under review.
Last year, while speaking at a Stanford panel focused on censorship and scientific expression, Tidmarsh voiced concerns over regulatory inconsistencies. He highlighted the agency’s rigid approach to off-label communication for manufacturers and contrasted it with the leniency shown during the pandemic, when vaccine advertisements aired without conventional disclaimers.
“This discrepancy shows that FDA may apply free speech regulation at a whim and inconsistently,” he said.
While recent scrutiny has largely centred on the FDA’s vaccine operations, CDER has been at the heart of some of the agency’s most controversial actions. Among them was the approval of marketing language that permitted opioids like OxyContin to be promoted for chronic pain, despite limited evidence of long-term benefit — a decision widely seen as contributing to the opioid crisis.
Tidmarsh recently revealed during a podcast appearance that he met Commissioner Makary at a Stanford conference last autumn. The event featured several participants critical of pandemic-era policies, many of whom now hold prominent government health roles.
He has expressed scepticism toward prevailing scientific consensus, echoing Makary’s criticisms. In a podcast from the previous year, Tidmarsh remarked that academia tends to suppress dissenting perspectives and warned about the concentration of grant funding within select groups.
In a LinkedIn post from 2024, he wrote, “academic science has become riddled with fraud, the time has come to root out the corruption.” He also funds the Sleuth in Residence initiative, which backs scientific fraud investigations conducted by Retraction Watch, a website that tracks article retractions in academic journals.
Tidmarsh earned both his MD and a PhD in cancer biology at Stanford, later joining the clinical faculty at the university. His professional background includes executive roles at several biotech firms, notably as CEO of La Jolla Pharmaceutical Co., which developed a treatment for sepsis and is now part of Innoviva Inc.
With training in paediatric oncology, Tidmarsh has also worked to address persistent shortages of essential generic cancer drugs. In a 2024 interview with a medical trade publication, he described the US generics market as the “wild west,” citing predatory contracting as a factor that deters manufacturers.
