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
January 31, 2002
8:00 a.m. Call to Order and Introductions Nathaniel P. Katz, M.D.
Acting Chair, ALSAC
Conflict of Interest Statement Kimberly L. Topper
Executive Secretary, 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.
Prescription Drug Abuse Deputy Director, DACADP, FDA
10:15 a.m. Current Data on Abuse and Diversion Judy Ball, Substance Abuse and
Mental Health Services Administration, (SAMHSA)
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,
Controlled Substance Staff, FDA
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