FOOD AND DRUG ADMINISTRATION

Center for Drug Evaluation and Research

ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE (ALSAC) MEETING

Holiday Inn, Ballrooms, 2 Montgomery Village Avenue, Gaithersburg, MD

8:00 a.m. Call to Order and Introductions Nathaniel P. Katz, M.D.

Acting Chair, ALSAC

8:05 a.m. Welcome to Second Day and Cynthia McCormick, M.D.

Introductory Comments Director, Division of Anesthetic,

Critical Care and Addiction

Drug Products (DACADP), FDA

8:15 a.m. Open Public Hearing

9:15 a.m. Industry Presentation J. David Haddox, M.D., D.D.S.

Senior Medical Director Health Policy

Purdue Pharma LP

10:05 a.m. Introduction to Session III: Bob Rappaport, M.D.

10:15 a.m. Current Data on Abuse and Diversion Judy Ball, Substance Abuse and

10:35 a.m. Break

10:50 a.m. Criminal Activity Associated with Drug Enforcement Administration

Opiate Analgesics (DEA)

11:10 a.m. FDA Assessment of Abuse Liability Deborah Leiderman, M.D., Director,

11:30 a.m. Discussion

11:45 a.m. Epidemiology of Prescription Drug Abuse: Howard Chilcoat, M.D.

Implications for the Clinical Setting Johns Hopkins University

12:15 p.m. Prescription Drug Abuse in Pain Patients Steven Passik, M.D.

Community Cancer Care Center, Inc.

12:45 p.m. Discussion

1:00 p.m. Lunch

2:00 p.m. Regulatory Approaches to Risk Management Sharon Hertz, M.D.

of Prescription Opioid Drug Abuse Medical Officer, DACADP, FDA

2:15 p.m. Questions and Discussion

5:30 p.m. Adjourn