Tidmarsh to stand in for Prasad's role at CBER
CDER director George Tidmarsh will now also take responsibility for CBER at the FDA.
The FDA has moved swiftly to fill the void left by Vinay Prasad's resignation as director of the Center for Biologics Evaluation and Research (CBER), appointing recent hire George Tidmarsh to the role.
The decision means that – for now, at least – industry veteran Tidmarsh will have acting responsibility for CBER in addition to his role as director of the Center for Drug Evaluation and Research (CDER), just nine days after joining the US regulator.
Prasad stepped down from the CBER role earlier this week, after only about three months, a move that reportedly stemmed from discontent over some of his recent regulatory decisions, as well as difficulties in winning over senior staffers at the unit and a campaign by right-wing activists for him to be removed.
While the hunt for a permanent director proceeds, Tidmarsh will be supported at CBER by deputy directors Scott Steele and Brittany Goldberg, both of whom have previously served as acting CBER director.
When Tidmarsh was appointed to CDER, the FDA emphasised his academic and clinical credentials – including his role as founding co-director of Stanford University's Master of Translational Research and Applied Medicine (M-TRAM) programme.
However, Tidmarsh is arguably better known for a long career in the biopharma industry that included spells as CEO of Horizon Therapeutics and La Jolla Pharma. His appointment has done little to dispel the notion of a 'revolving door' between the US drugs regulator and industry, particularly as his permanent predecessor at CDER, Patricia Cavazzoni, left the agency to become Pfizer's chief medical officer.
Tidmarsh recently stepped down as chair of Revelation Biosciences on the grounds that he would be working closely with US agencies and that the work may pose a conflict of interest. CDER was his first government position.
When his CDER role was announced, Tidmarsh was described by FDA Commissioner Marty Makary as "an accomplished physician-scientist and leader whose experience spans the full arc of drug development – from bench to bedside."
Makary 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."
Leerink analyst Joseph Schwartz said Prasad's departure was a "net positive" for the biopharma industry, as he was viewed as introducing "regulatory risk."
