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23 June 2003 CONFIDENTIAL -- NOT FOR DISSEMINATION PalladoneTM CapsulesRisk Management Program Food and Drug AdministrationCenter for Drug Evaluation and ResearchAnesthetic and Life Support Drugs Advisory Committee MeetingSeptember 10, 2003 Speakers J. David Haddox, DDS, MD Vice President, Health Policy Purdue Pharma L.P. Sidney H. Schnoll, MD, PhD Executive Medical Director, Health Policy Purdue Pharma L.P. Herbert D. Kleber, MD Director, Division on Substance Abuse Professor of Psychiatry College of Physicians and Surgeons Columbia University Formerly Deputy Director, Demand Reduction White House Office of National Drug Control Policy Consultants Theodore J. Cicero, PhD Vice-Chancellor for Research Professor, Neurobiology Washington University in St. Louis James A. Inciardi, PhD Director, Center for Drug and Alcohol Studies Professor, Criminal Justice University of Delaware Richard C. Dart, MD, PhD Director, Rocky Mountain Poison and Drug Center Professor, Surgery (Emergency Medicine) University of Colorado Agenda Purdue Pharma L.P. PositionRisk Management Programs (RMPs) for Opioid Analgesics Must protect patients Must balance the legitimate needs of patients against the risks posed to abusers Needed for all opioid medications Must be consistent within the same schedule in the Controlled Substances Act (CSA) Must consider three distinct populations Patients Abusers Criminals Purdue Pharma L.P. Position(continued) No single group can implement an effective risk management program for opioid analgesics that addresses all three populations This is a multifaceted challenge requiring coordinated, cooperative and consistent efforts from Industry Law Enforcement Regulators Educators Government Community Leaders Healthcare Patients and Professionals Caregivers PalladoneTM Capsules PalladoneTM Capsules  Introduction Oral opioid analgesics are an effective therapy for appropriately s