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Cost of Caution: The Impact on Patients of Delayed Drug Approvals

Monday June 2010


Tomas Philipson, Ph.D University of Chicago
Eric Sun, M.D., Ph.D. Stanford University

In the nearly twenty years since the Prescription Drug User Fee Act (PDUFA) was passed, drug development has become an expensive and time-consuming process—estimated to take over a decade and cost producers nearly $1 billion per drug—mainly because of mandated FDA clinical trials. With the FDA starting hearings and meetings regarding the reauthorization of PDUFA, Congress has a critical opportunity to expand on the legislation’s original goals and help the FDA grant patients faster access to more innovative drug therapies.

In a new study published by the Manhattan Institute’s Project FDA, economists Tomas Philipson and Eric Sun uncover how traditional estimates of drug-development costs do not factor in how developmental delays affect patients, and thus understate the full costs to society in terms of lost lives.

Could correctly accounting for such delays actually improve and save lives? As we near the reauthorization of PDUFA, what can policymakers and the FDA do to help streamline the drug development and approval process?

Introduction: Paul Howard, Ph.D., Director, Center for Medical Progress, Senior Fellow, Manhattan Institute
Panelists: Tomas Philipson, Ph.D., University of Chicago, Eric Sun, M.D., Ph.D., Stanford University, Randall Lutter, Visiting Fellow, Resource for the Future, United States Capitol Visitors Center