Time Enough for Safety: Comment on “The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety”

Carpenter, Chattopadhyay, Moffitt, and Nall (2012) present results that suggest that time constraints on new-drug reviews are positively associated with post-market safety outcomes. However, their analysis omits obvious confounding variables, and their data set contains several clear errors. In regressions using a clean data set and plausible confounding variables, we find that the relationship between time constraints on new-drug reviews and post-market safety events is neither robust nor statistically significant.