Food and Drug Administration commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s top drug regulator, the agency confirmed Monday.
Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University, will serve as director of the Center for Drug Evaluation and Research, one of the FDA’s largest and most important divisions with a staff of about 5,700 that reviews the vast majority of new drug applications. Jacqueline Corrigan-Curay, the acting head of the CDER, recently announced she was leaving the agency.
Tidmarsh, 65, was involved in the development of several approved drugs, likely making him a reassuring choice for a pharmaceutical industry that’s facing pressure from the Trump administration to lower prices and move manufacturing to the US.
Tidmarsh’s appointment “brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,” Brian Abrahams, an analyst at RBC Capital Markets, said in a note to clients. While recent cuts at the agency have raised concerns about the FDA’s drug approval process, “we would expect Tidmarsh to be a pragmatic officer who will likely build upon current practice to ensure continuity and potentially be an advocate for the industry.”
Among the controversies Tidmarsh will contend with is the agency’s accelerated approval process. The use of this expedited pathway to get drugs green lit has skyrocketed in recent years and been criticized for sometimes letting unproven treatments linger on the market for too long. Advocates say speeding up the process gets drugs quickly to patients suffering from serious diseases.
Tidmarsh is also primed to be a key player in reassessing the agency’s approach to regulating prescription drug advertising. Health Secretary Robert F. Kennedy Jr. has long been a critic of direct-to-consumer drug advertising, and Makary has indicated that the agency is reviewing its approach to regulating such ads.
During a panel on censorship and scientific speech at Stanford last year, Tidmarsh raised concerns about the FDA’s inconsistent regulation of pharmaceutical products. He pointed to the agency’s long-standing restrictions on off-label communication by manufacturers and questioned some vaccine makers’ ads during the pandemic.“This discrepancy shows that FDA may apply free speech regulation at a whim and inconsistently,” he said.
While the FDA’s vaccine division has been in the spotlight recently over Covid shots, the drug division has made some of the agency’s most controversial decisions. In the ’90s, CDER approved language allowing opioid drugs, such as OxyContin, to be widely marketed — despite a lack of substantial evidence supporting their long-term effectiveness. The move helped pave the way for the opioid epidemic. The division also caused a firestorm after approving the Alzheimer’s treatment Aduhelm that hadn’t clearly been proven to work in research studies.
On a recent podcast, Tidmarsh said he met Makary at a conference last fall at Stanford. It featured many people critical of restrictions and mandates during the pandemic, several of whom now have top government health jobs.
Tidmarsh appears to share Makary’s concerns about a lack of dissenting viewpoints in science. In a podcast about a year ago, he said academics foster a culture that is reluctant to question prevailing views and that grantmaking has become concentrated into a few hands.
On LinkedIn last year, Tidmarsh wrote that “academic science has become riddled with fraud, the time has come to root out the corruption.” He funds the Sleuth in Residence program that supports scientific fraud investigators at the website Retraction Watch, which tracks academic journals.
At Stanford, Tidmarsh got both his medical degree and a PhD in cancer biology and then worked in the school’s clinical faculty. He also had a series of biotech jobs, including chief executive officer for La Jolla Pharmaceutical Co., which developed a drug to treat sepsis and is now part of Innoviva Inc.
Tidmarsh, who was also trained in pediatric oncology, has worked over the years to find solutions to shortages of old lifesaving cancer drugs. In an interview last year with a publication for doctors, he likened the US generic drug market to a “wild west” where predatory contracting practices can drive out manufacturers.
Langreth and Hornblower write for Bloomberg.