I think this essay
by Dr. Henry Miller is worth pondering. In it he discusses some of the complex rocks and hard spots the FDA often finds itself between. Miller mentions a great quote by former FDA commissioner Alexander Schmidt:
"In all our FDA history, we are unable to find a single instance where a Congressional committee investigated the failure of FDA to approve a new drug. But the times when hearings have been held to criticize our approval of a new drug have been so frequent that we have not been able to count them. The message to FDA staff could not be clearer."
Maybe this isn't a job any of us would want?