Last Friday, George Tidmarsh, the Food and Drug Administration’s (FDA) chief drug regulatory officer, was called into Commissioner Marty Makary’s office for an unscheduled meeting. Tidmarsh assumed Markary would say Vinay Prasad, the head of the FDA center that oversees vaccines and biological products, is no longer with the agency after the publication of an article detailing unrest among employees working in the department.
Tidmarsh would have welcomed that possibility. “I think that guy should be fired,” he later said of Prasad in an interview with STAT. “This person at work is not going to see the light of day on Monday morning. There is a person whose life is at stake and who is unbalanced.”
Instead, Tidmarsh was told he had been placed on administrative leave for using his regulatory powers to target former business associates.
It was the latest shock wave to sweep through the agency, which has been embroiled in all sorts of turmoil in recent months. In interviews, observers characterized a flood of dismissals, policy reversals and controversies of all kinds. It’s a soap opera. It’s unpredictable. I’m completely confused. And potentially unprincipled.
On the outside, experienced FDA watchdogs see a combination of nitty-gritty details and real, important ethical and scientific questions that could discredit the agency and put Americans’ health at risk.
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