Abstract
Approaching the end of her first year as commissioner of the Food and Drug Administration (FDA), Dr. Margaret Hamburg remarked that, despite past experience with government bureaucracies, she is struck by how hard it is to make her agency act quickly. “You feel it differently at the FDA — how long it takes to move things through the system,” she told an audience at the Institute of Medicine (IOM) in February. “The process of regulation does not allow you to respond in a timely way to emerging science or to other important emerging concerns.” The FDA's principal deputy commissioner, Dr. Joshua Sharfstein, put it more bluntly in a recent interview: “I keep a list of things that I wish were moving faster and a list of things moving at just the right speed, and there's nothing on the second list.”

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