- The FDA has named Dr. George Tidmarsh, a veteran biotech executive and Stanford professor, as head of its Center for Drug Evaluation and Research (CDER), which oversees drug safety and approvals.
- Tidmarsh helped develop seven FDA-approved drugs and previously led La Jolla Pharmaceutical and Horizon Pharma, securing key drug approvals during his tenure.
- Tidmarsh has publicly criticized the FDA's past decisions, calling for the removal of outdated or harmful drugs and questioning the agency's consistency in regulating free speech by drug manufacturers.
- He has endorsed FDA Commissioner Marty Makary's efforts to reevaluate long-approved substances like talc using modern scientific standards.
- While Tidmarsh hasn't commented on his appointment, his past statements suggest he may pursue regulatory reforms and push for greater scientific rigor at CDER.
The U.S. Food and Drug Administration (FDA) has appointed Dr. George Tidmarsh, a seasoned biotechnology executive and academic, to lead the agency's Center for Drug Evaluation and Research (CDER), a critical arm of the FDA responsible for overseeing the safety and effectiveness of prescription drugs.
Tidmarsh, an adjunct professor at Stanford University (SU), brings decades of experience in pharmaceutical development and leadership. He has played a key role in the development of seven FDA-approved drugs throughout his career. (Related: FDA to remove Pharma reps from advisory panels, aiming to restore public trust.)
"Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development – from bench to bedside," said FDA Commissioner Dr. Marty Makary. "His appointment to lead CDER brings exceptional scientific, regulatory and operational expertise to the agency. I look forward to working with him to strengthen our drug review programs, foster innovation and advance cross-agency initiatives that improve health outcomes for the American public."
Tidmarsh is perhaps best known for his tenure as president and CEO of La Jolla Pharmaceutical Company from 2012 to 2019, during which time the company secured FDA approval for angiotensin II, a hormone therapy for patients experiencing shock. He also founded Horizon Pharma Inc., where he led efforts to gain FDA approval for a treatment for rheumatoid arthritis.
In addition to his executive roles, Tidmarsh has held senior leadership positions at several other pharmaceutical firms and continues to teach and mentor students at SU's School of Medicine.
Tidmarsh has been a critic of FDA's past decisions and free speech policies
Tidmarsh has not publicly responded to news of his appointment, but past statements suggest he may bring a reform-minded agenda to one of the agency's most influential divisions.
CDER, which evaluates new drugs before they reach the market and monitors their safety post-approval, employs roughly 5,000 people and has an annual budget of $1 billion. The division is responsible for evaluating new drug applications, ensuring labeling accuracy and monitoring post-market safety.
However, its past decisions have been the focus of scrutiny.
Tidmarsh has previously expressed pointed views on the FDA's role and operations. In a 2020 LinkedIn post following President Donald Trump's first victory, he urged the agency to act more aggressively in removing the "harmful, useless drugs" from the market. He singled out desiccated thyroid extract, a pig-derived treatment used for hypothyroidism, as an example, calling it an "unapproved, crude pig tissue extract" that is "proven worse than synthetic thyroid hormone and harmful."
In a podcast recorded earlier this year, Tidmarsh discussed meeting Makary at a 2024 panel at SU. He then expressed support for Makary's effort to reevaluate older FDA-approved substances, such as talc, in light of modern science.
As moderator of that panel, Tidmarsh also raised concerns about how the FDA regulates drug company speech, citing a report from journalist Lee Fang. He argued that the agency applies First Amendment standards inconsistently when companies make claims beyond the language on drug labels. In a related blog post, he criticized the FDA's "uneven application of basic clinical trial data interpretation," warning that it undermines the credibility and neutrality of the agency.
Head over to FDA.news for more similar stories.
Watch Robert Scott Bell and Nicole Mueller-Yuri discussing why a shakeup of the FDA's advisory boards is a good thing in this clip.
This video is from The Robert Scott Bell Show channel on Brighteon.com.
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