FDA Leadership Shakeup: Tidmarsh Takes Reins at CBER Amid Prasad's Sudden Departure

In a surprising turn of events, the U.S. Food and Drug Administration (FDA) has appointed George Tidmarsh, M.D., Ph.D., as the acting director of the Center for Biologics Evaluation and Research (CBER) following the abrupt resignation of Vinay Prasad, M.D. This development comes just nine days after Tidmarsh assumed leadership of the Center for Drug Evaluation and Research (CDER), marking a significant shift in the agency's top ranks.

Prasad's Brief Tenure and Controversial Exit

Vinay Prasad's departure from the FDA comes less than three months into his role as CBER director. His short tenure was marked by controversy, particularly surrounding the regulatory decisions involving Sarepta Therapeutics' gene therapy, Elevidys. Prasad faced criticism from conservative circles, with some targeting his past support for left-leaning politicians and alleged departures from Trump administration directives.

The final days of Prasad's leadership saw a tumultuous series of events related to Elevidys. Following a third patient death in a trial for another Sarepta AAV-based gene therapy, the FDA revoked the company's Platform Technology designation and requested a temporary halt in drug shipments. A fourth patient death in Brazil prompted an FDA investigation, which concluded that the fatality was not linked to Elevidys. The agency subsequently recommended lifting the voluntary hold for ambulatory patients, with Prasad resigning the following day.

Tidmarsh's Expanded Role and Industry Background

George Tidmarsh, a veteran biotech executive with no prior government experience, now finds himself at the helm of both CDER and CBER. His appointment to these crucial roles comes with high expectations, given his track record of overseeing the development of seven FDA-approved drugs across various smaller pharmaceutical companies.

FDA Commissioner Marty Makary, M.D., announced Tidmarsh's expanded responsibilities in an internal letter to staff. The move is seen as a stopgap measure while the agency searches for a permanent CBER director. Industry analysts, such as Leerink Partners' Mani Foroohar, M.D., view internal promotions favorably, noting their potential to maintain continuity and respect within the organization.

Restructuring and Future Outlook

Accompanying Tidmarsh's appointment, the FDA has named Scott Steele, Ph.D., and Brittany Goldberg, M.D., as deputy directors of CBER. Steele, a University of Rochester professor, has been serving as a senior advisor to CBER since 2022. Goldberg, an infectious disease physician, brings 13 years of experience as the division's chief medical officer. Both have previously served as acting CBER directors.

As the FDA navigates this transition, questions remain about the long-term leadership of CBER and the potential impact on ongoing regulatory processes, particularly in the rapidly evolving fields of cell and gene therapies. The agency has not yet commented on its plans to conduct a search for a permanent CBER leader, leaving the industry to speculate on the future direction of this critical regulatory body.