FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE (ALSDAC)
Holiday Inn, Ballrooms, 2 Montgomery Village Avenue, Gaithersburg, MD
January 30, 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, ALSDAC
8:20 a.m. Welcome and Introductory Comments Cynthia McCormick, M.D.
Director, Division of Anesthetic,
Critical Care and Addiction
Drug Products (DACADP), FDA
8:35 a.m. Open Public Hearing
9:50 a.m. Introduction to Session I: Bob Rappaport, M.D.
Opiate Analgesic Development and Use Deputy Director, DACADP, FDA
10:00 a.m. Pain Treatment Guidelines Bruce Allen Levy, M.D., J.D.
10:30 a.m. Treatment of Patients with Chronic Pain Russell Portenoy, M.D.
Department of Pain Medicine and Palliative Care
Beth Israel Medical Center
11:00 a.m. Break
11:15 a.m. Opiate Analgesic Trials and Gerald DalPan, M.D.
Drug Development Plans Medical Officer, DACADP, FDA
11:30 p.m. Questions and Discussion
12:30 p.m. Lunch
1:30 p.m. Introduction to Session II Bob Rappaport, M.D.
Opiate Analgesic Use in Pediatric Patients Deputy Director, DACADP, FDA
1:45 p.m. Pediatric Analgesic Use Debra Friedman, M.D.
University of Washington, Children's Hospital and Regional Medical Center
2:15 p.m. Pediatric Exclusivity and the Pediatric Rule Rosemary Roberts, M.D.
Pediatrics Team, FDA
2:40 p.m. Pediatric Opiate Analgesic Trials Nancy Chang, M.D.
and Development Plans: Case Studies Medical Officer, DACADP, FDA
3:00 p.m. Questions and Discussion
5:30 p.m. Adjourn