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The Complications of Controlling Agency Time Discretion: FDA Review Deadlines and Postmarket Drug Safety

Authors


  • For critical remarks and helpful discussions, we thank Jerry Avorn, Einer Elhauge, Gary King, Bruce Psaty, Meredith Rosenthal, Katherine Swartz, Heidi Williams, the Editor and anonymous reviewers, and audiences at Harvard Medical School, Harvard Law School, the Keck Graduate Institute of Applied Life Sciences, and the Ohio State University. Carpenter acknowledges the National Science Foundation (SES-0076452 and SES-0351048), a Robert Wood Johnson Foundation Investigator Award in Health Policy Research, and the Safra Center for Ethics at Harvard University. Carpenter and Moffitt also acknowledge the Robert Wood Johnson Foundation Scholars in Health Policy Research Program. All replication data and code for this article will be available on the date of publication at http://people.hmdc.harvard.edu/~dcarpent/fdaproject/deadlinesstudy2011.html.

Daniel Carpenter is Allie S. Freed Professor of Government, Harvard University, 1737 Cambridge Street, Cambridge, MA 02138, and (2011–2012) Visiting Researcher, Institut d’Études Politiques, Université de Strasbourg, France (dcarpenter@gov.harvard.edu). Jacqueline Chattopadhyay is a Ph.D. candidate in Government & Social Policy, Harvard University, 1737 Cambridge Street, Cambridge, MA 02138 (jchattop@fas.harvard.edu). Susan Moffitt is Mary Tefft and John Hazen White Sr. Assistant Professor of Political Science, Brown University, 36 Prospect Street, Providence, RI 02912 (Susan_Moffitt@brown.edu). Clayton Nall is Assistant Professor of Political Science, Stanford University, 616 Serra Street, Encina Hall West, Room 100, Stanford, CA 94305–6044 (nall@stanford.edu).

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.

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