Fresh off his appointment as the head of the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), Dr George Tidmarsh has been signed in as temporary director of the agency's Center for Biologics Evaluation and Research (CBER).
This appointment was confirmed to Pharmaceutical Technology by a spokesperson for the US Department of Health and Human Services (HHS).
Juggling the leadership of both CDER and the CBER, Dr Tidmarsh’s latest appointment will attempt to bring stability to the latter, which was left reeling after the sudden exit of its former lead Vinay Prasad.
Prasad stepped down from his role after just three months of service, a decision likely driven by growing criticism from conservatives for his handling of cell and gene therapy (CGT) approvals.
A very public back-and-forth between CBER and Sarepta Therapeutics, producer of Duchenne muscular dystrophy (DMD) gene therapy Elevidys, only further soured opinions on the former director, with his call to pause US shipments being reversed just days later following industry backlash.
Only a day after Prasad’s departure, an internal letter from FDA Commissioner Marty Makary confirmed that Tidmarsh will temporarily steer the regulatory efforts of the department while the FDA seeks out a more permanent replacement.
The regulator did not respond to Pharmaceutical Technology’s request for further comment about its recruitment plans for the position.
The document also confirms that deputy directors Scott Steele and Brittany Goldberg will continue to serve in their respective positions within the CBER executive committee.
Dr Tidmarsh has more than three decades of experience in the worlds of biotech, regulatory science and clinical medicine, though this month marks his first venture into federal waters, with his tenure as director of CDER starting just nine days ago.
