Copyright STAT
Last Friday, George Tidmarsh, the top drug regulator at the Food and Drug Administration, was pulled into Commissioner Marty Makary’s office for an unscheduled meeting. Tidmarsh assumed Markary was going to tell him Vinay Prasad, director of the FDA center that oversees vaccines and biologics, was no longer with the agency, following the publication of a story that detailed unrest among employees working in that division. Tidmarsh would have welcomed that possibility. “I think you should fire that person,” he said of Prasad in an interview later with STAT. “In a company, this person would not see the light of day on Monday morning. Lives are at stake, and you have someone unbalanced.” Advertisement Instead, Tidmarsh was told he was being put on administrative leave — accused of using his regulatory authority to target a former business associate. It was the latest shockwave to sweep through an agency beset by all kinds of tumult in recent months. In interviews, observers characterized the spate of dismissals, policy reversals, and controversies in all kinds of ways: Soap opera. Unpredictable. In total disarray. And, potentially, unprincipled. From the outside, experienced FDA-watchers see a combination of real and important ethical and scientific questions and tawdry details that risk discrediting the agency, and could also put the health of Americans at risk.
