title: The complications of controlling agency time discretion: FDA review deadlines and postmarket drug safety.
abstract: Public agencies have discretion on the time domain, and politicians deploy numerous policy instruments to constrain it. Yet little is known about how administrative procedures that affect timing also affect the quality of agency decisions. We examine whether administrative deadlines shape decision timing and the observed quality of decisions. Using a unique and rich dataset of FDA drug approvals that allows us to examine decision timing and quality, we find that this administrative tool induces a piling of decisions before deadlines, and that these “just-before-deadline” approvals are linked with higher rates of postmarket safety problems (market withdrawals, severe safety warnings, safety alerts). Examination of data from FDA advisory committees suggests that the deadlines may impede quality by impairing late-stage deliberation and agency risk communication. Our results both support and challenge reigning theories about administrative procedures, suggesting they embody expected control-expertise trade-offs, but may also create unanticipated constituency losses.
authors.affiliation: Harvard University.
authors.forename: Daniel
authors.initials: D
authors.lastname: Carpenter
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Chattopadhyay
authors.forename: Susan
authors.initials: S
authors.lastname: Moffitt
authors.forename: Clayton
authors.initials: C
authors.lastname: Nall
mesh_terms: D003657:Decision Making; D017277:Drug Approval / Q000191:economics / Q000266:history / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000191:economics / Q000193:education / Q000266:history / Q000331:legislation & jurisprudence; D049673:History, 20th Century; D049674:History, 21st Century; D009934:Organization and Administration / Q000191:economics; D011358:Product Surveillance, Postmarketing / Q000191:economics; D011634:Public Health / Q000191:economics / Q000193:education / Q000266:history / Q000331:legislation & jurisprudence; D014481:United States / Q000208:ethnology; D014486:United States Food and Drug Administration / Q000191:economics / Q000266:history / Q000331:legislation & jurisprudence