FDA Names Biotech Veteran George Tidmarsh To Lead Drug Evaluation Division

The U.S. Food and Drug Administration appointed George F. Tidmarsh on Monday as director of the Center for Drug Evaluation and Research (CDER).

Tidmarsh earned his M.D. and Ph.D. in cancer biology from Stanford University, where he completed residency training in pediatrics.

He completed two subspecialty programs at Stanford, one in pediatric oncology and another in neonatology. He brings over 30 years of experience in biotechnology, clinical medicine and regulatory science, and has authored 143 scientific publications and patents. 

Tidmarsh is stepping in as the FDA faces major changes under Health and Human Services Secretary Robert F. Kennedy Jr.

Kennedy has pushed for large staff cuts at HHS and has hired some people who share his doubts about vaccines.

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Still, the pharmaceutical industry may feel some relief with Tidmarsh’s appointment. He has a strong background in drug development, having helped bring seven approved drugs to market. However, his past remarks suggest he might take a tougher stance on drug regulation.

Citing an opinion piece published in April, CNBC says Tidmarsh criticized decisions made by Peter Marks, a top FDA official removed under Kennedy. Tidmarsh opposed the fast-tracking of Biogen Inc’s (NASDAQ:BIIB) controversial Alzheimer’s drug Aduhelm and disagreed with the decision to expand approval for Sarepta Therapeutics Inc’s (NASDAQ:SRPT) muscular dystrophy drug Elevidys, which overruled FDA staff.

Tidmarsh’s appointment “brings in a generally well-respected, credible industry veteran, we believe helping fill a key regulatory void,” Bloomberg wrote, citing Brian Abrahams, an analyst at RBC Capital Markets.

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.”

The Bloomberg report added that one of the big challenges facing Tidmarsh is the FDA's accelerated drug approval process. This faster track for getting drugs approved has become more common in recent years. While supporters say it helps patients with serious illnesses get treatments faster, critics argue it allows some unproven drugs to stay on the market for too long.

Tidmarsh is also expected to play a major role in rethinking how the agency regulates prescription drug advertising. Kennedy Jr. has been outspoken against drug ads aimed at consumers, and agency official Marty Makary said the current rules are under review.

Last year, at a Stanford panel on censorship and scientific speech, Tidmarsh criticized the FDA for being inconsistent in regulating drugs.

He pointed out the agency's strict rules on how drugmakers can talk about off-label uses and questioned some vaccine ads shown during the COVID-19 pandemic.

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