FDA commissioner Margaret Hamburg and principal deputy commissioner Joshua Sharfstein say they are concerned by how long it takes to make changes in the agency. Their comments were reported in a New England Journal of Medicine assessment of their first year at the helm of FDA.
Hamburg told a February Institute of Medicine meeting that despite her past experiences working in government, she was struck by how long it takes to make a change at FDA. “You feel it differently at FDA —how long it takes to move things through the system,” she said. “The process of regulation does not allow you to respond in a timely way to emerging science or to other important emerging concerns.”
Sharfstein put it more bluntly: “I keep a list of things that I wish were moving faster and a list of things moving at just the right speed,” he said, “and there's nothing on the second list.”
The report said that Hamburg and Sharfstein have been trying to find ways to make FDA more nimble and proactive.