FDA appoints biotech industry veteran as RFK Jr.'s top drug regulator

FDA appoints biotech industry veteran as RFK Jr.'s top drug regulator

The U.S. Food and Drug Administration (FDA) has appointed George Tidmarsh, a seasoned biotech executive and Stanford University professor, as the director of the Center for Drug Evaluation and Research (CDER). Tidmarsh, an adjunct professor of pediatrics and neonatology at Stanford University, will oversee one of the FDA's largest and most important divisions, which regulates over-the-counter and prescription drugs [1].

Tidmarsh brings over three decades of experience in biotechnology, regulatory science, and clinical medicine to the role. He has authored 143 scientific papers and patents and played a central role in developing seven FDA-approved drugs. His extensive background includes serving as the CEO of Horizon Pharma and holding senior positions at other biotechs such as SEQUUS Pharmaceuticals and Coulter Pharmaceutical [1, 2].

The appointment of Tidmarsh comes as the FDA faces significant challenges under the current administration. Health and Human Services Secretary Robert F. Kennedy Jr. has pursued deep staff cuts across the agency, raising concerns about the FDA's ability to approve drugs smoothly. However, Tidmarsh's appointment is seen as a reassuring choice for the pharmaceutical industry, given his extensive industry experience and involvement in the development of approved drugs [3].

Tidmarsh's appointment also comes with controversies. He has been critical of the FDA's accelerated approval process, which has been criticized for letting unproven treatments linger on the market for too long. Additionally, he has raised concerns about the FDA's approach to regulating prescription drug advertising and the agency's inconsistent regulation of pharmaceutical products [3].

Despite these challenges, Tidmarsh's appointment is likely to bring a pragmatic and industry-focused approach to the FDA. His experience in drug development and his understanding of the regulatory process are expected to help fill a key regulatory void and ensure continuity in the agency's operations [3].

References:
[1] https://www.usatoday.com/story/money/business/2025/07/21/fda-george-tidmarsh-drug-regulator/85309432007/
[2] https://www.cnbc.com/2025/07/21/fda-george-tidmarsh-as-rfk-jr-top-drug-regulator.html
[3] https://www.seattletimes.com/business/fda-to-appoint-biotech-executive-as-rfk-jr-s-top-drug-regulator/