Working Paper Series

W35- Deadline Effects in Drug Regulatory Review, Daniel Carpenter (Cohort 5 - Michigan Program), Jake Bowers (Cohort 12 - Harvard Program), Justin Grimmer, Susan Moffitt (Cohort 13 - Harvard Program), Clayton Nall, and Evan James Zucker, February 2007.

This paper elaborates statistical models for the analysis of regulatory review deadlines or “review time goals” and their influence upon regulatory decisions. We outline two sets of statistical methods for estimating the models. In the first set, dynamic duration models of time to decision are elaborated, with particular focus on semi-parametric methods from which the behavioral structure of a regulatory review can be induced or “backed out.” In the second set, we consider different estimators for observational analysis of whether the deadlines in question influence the “quality” of the reviews or the likelihood of error. In particular, we consider how to use results from the “first stage” (induced behavioral review structure) to test whether deadlines influence the distribution of error. We apply these methods to the imposition of review-time goals by the Prescription Drug User-Fee Act (PDUFA) and its amended successors upon new drug review by the U.S. Food and Drug Administration (FDA). Using the first set of methods, we find broad evidence that the deadlines have induced a piling of approvals right before the deadline elapses. Using the second set of methods, we find that these “pre-deadline” approvals are subject to substantially different post market experiences than drugs approved either after the deadlines or “very early” in the approval process.

Daniel Carpenter is Professor of Government and Director of Graduate Studies, Department of Government at Harvard University (dcarpenter@latte.harvard.edu ).

Jake Bowers is an RWJ Scholar in Health Policy Research at Harvard University.

Justin Grimmer is a Ph.D. student in the Department of Government and Research Associate with the Institute for Quantitative Social Science at Harvard University.

Susan Moffitt is an RWJ Scholar in Health Policy Research at Harvard University.

Clayton Nall is a Ph.D. student in the Department of Government and Research Associate with the Institute for Quantitative Social Science at Harvard University.

Evan James Zucker is an M.D. student at the Harvard Medical School.

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