(Bloomberg) — Food and Drug Administration Commissioner Marty Makary has chosen former biotech executive George Tidmarsh as the agency’s top drug regulator, according to a person familiar with the decision.
The naming of Tidmarsh, also a Stanford University-affiliated pediatrician, to director of the Center for Drug Evaluation and Research could be announced as soon as Monday, said the person who asked not to be identified because the appointment wasn’t public.
At the CDER, the 65-year-old Tidmarsh will oversee one of the FDA’s largest and most important divisions with a staff of about 5,700 that reviews the vast majority of novel drug applications. Jacqueline Corrigan-Curay, the acting head of the CDER, recently announced she was leaving the agency.
The biotech veteran 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 drug manufacturing to the US.
Among the controversies Tidmarsh will face is accelerated approvals, a practice that has skyrocketed in recent years and been criticized for sometimes letting unproven drugs linger on the market 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, while contrasting that with vaccine makers running consumer ads during the pandemic without standard disclosures.
“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. The CDER approved language allowing opioid drugs, such as OxyContin, to be marketed for chronic pain — despite a lack of substantial evidence supporting their long-term effectiveness. The move helped pave the way for the opioid epidemic.
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 criticisms of scientific group think. In a podcast about a year ago, he said academics foster a culture that suppresses dissenting ideas and that grant-making 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 follows retractions in academic journals.
At Stanford, Tidmarsh got both his medical degree and a Ph.D. in cancer biology and then worked in a clinical faculty at the California school. 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.
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