FDA names a new CDER director, choosing a biotech vet
The FDA has a new director for the Center for Drug Evaluation and Research (CDER), with biopharma industry executive George Tidmarsh named to the role.
The appointment comes more than six months after Patrizia Cavazzoni stepped down as CDER director, just before President Trump took office for his second term, and a few weeks after acting director Jacqueline Corrigan-Curay revealed she would be retiring from the regulator this month.
Tidmarsh – a Stanford University-affiliated physician scientist and former chief executive at biopharma companies including La Jolla Pharma, Solano Therapeutics, and Horizon Pharma – recently stepped down as Chair of Revelation Biosciences on the grounds that he would be working closely with US governmental agencies and that the work may pose a conflict of interest. This is his first government position.
According to the FDA, Tidmarsh will "lead the FDA's efforts to ensure safe, effective, and high-quality drugs are available to the American people."
Tidmarsh was involved in the development of several approved drugs, a heritage that will no doubt endear him to the biopharma industry as it faces a rapidly changing regulatory climate in the US, ongoing efforts to reduce medicine prices, and the threat of tariffs.
However, his close relationship to the drug sector in recent years will do little to dispel allegations that there continues to be a "revolving door" between the FDA and industry.
"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 Marty Makary in a statement this morning.
"His appointment to lead CDER brings exceptional scientific, regulatory, and operational expertise to the agency," he added. "I look forward to working with him to strengthen our drug review programmes, foster innovation, and advance cross-agency initiatives that improve health outcomes for the American public."
The appointment rounds out the top leadership at the FDA after Makary was named Commissioner and Vinay Prasad claimed the role of director of the Center for Biologics Evaluation and Research (CBER) after former incumbent Peter Marks was pushed out.
In a recently published letter, Makary and Prasad said their priorities for the FDA in the coming years will include shorter review timelines for drug development, embracing the use of artificial intelligence and big data, and speeding up approvals for biosimilar and generic medicines.
