George Tidmarsh has only been at the Center for Drug Evaluation and Research for nine days, but will now add supervision of a second FDA division to his portfolio after Vinay Prasad’s sudden departure.
A day after the FDA’s Center for Biologics Evaluation and Research chief Vinay Prasad unexpectedly stepped down, the agency announced that the head of its sister group will take over in an acting capacity.
Wednesday afternoon, the FDA confirmed to Endpoints News that George Tidmarsh, recently installed as the head of the Center for Drug Evaluation and Research (CDER), will oversee CBER as well while the search for a new director proceeds.
Before joining CDER, Tidmarsh had no government experience but did possess plenty of pharma industry gravitas, having helmed a series of smaller companies that accrued a total of seven FDA-approved drugs.
Prasad had been running CBER for less than three months when he stepped down suddenly Tuesday evening. He had become the target of a storm of conservative criticism in the form of critical articles in the Wall Street Journal and appeals for his firing from far-right activist Laura Loomer.
Some of the criticism focused on Prasad’s past support for left-leaning politicians like Bernie Sanders, while Loomer zoomed in on how Prasad had gone against some of President Donald Trump’s directives, including matters like allowing remote work when Trump had forbidden it, as well as a series of missed PDUFA deadlines.
Prasad’s downfall followed a roller coaster of decisions around Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy Elevidys. After a third patient death—this one of a 51-year-old patient in a trial for another Sarepta AAV-based gene therapy—the FDA revoked the company’s Platform Technology designation and asked Sarepta to stop shipping the drug, at least temporarily. On Friday, after a fourth patient, a child with DMD, died in Brazil after receiving the treatment, the FDA declared that it was investigating.
On Monday, the FDA closed the investigation, determining that this fatality was not linked to Elevidys, and recommended that the voluntary hold be lifted for ambulatory patients. Prasad resigned the following day.
