Gastrointestinal Drugs Advisory Committee
Food and Drug Administration
Center for Drug Evaluation and Research
Holiday Inn, 8120 Wisconsin Ave., Bethesda, MD
Risk management for (NDA) 21-107, Lotronex™ (alosetron), GlaxoSmithKline
Agenda for April 23, 2002
8:00 Call to Order, Introductions:M. Michael Wolfe, M.D., Chair
Meeting Statement: Thomas H. Perez, M.P.H., Executive Secretary
Opening Comments: Florence Houn, M.D., M.P.H., Director, Office of Drug Evaluation III
Paul Seligman, M.D., Director,
Office of Pharmacoepidemiology and Statistical Science
8:15 GlaxoSmithKline Presentation
Introduction James B.D. Palmer, M.D.
Burden of Illness & Efficacy of Alosetron Peter Traber, M.D.
Safety Assessment & Benefit Risk Overview Eric Carter, M.D., Ph.D.
Proposed Risk David Wheadon, M.D.
Management Plan Clinician’s Perspective Robert Sandler, M.D.
Summary and Conclusions James B.D. Palmer, M.D.
10:00 FDA Presentation
Introduction Victor Raczkowski, M.D.
Lotronex: Clinical Trial Experience Thomas Permutt, Ph.D.
Post-Marketing Experience with Lotronex Ann Corken Mackey, M.P.H.
Risk-Benefit Issues Victor Raczkowski, M.D.
Lotronex Risk-Management Program Toni Piazza-Hepp, Pharm.D.
Summary and Conclusions Victor Raczkowski, M.D.
11:00 Questions on Presentations
11:30 Open Public Hearing
1:45 Introduction to Questions & Charge to the Committee Victor Raczkowski, M.D.
1:55 Discussion of Questions
3:40 Discussion of Questions – continued
Advisory Committee for Pharmaceutical Science members (Voting)
Gloria Anderson, Ph.D., Fuller E. Callaway Professor of Chemistry, Morris Brown College
Jurgen Venitz, M.D., Ph.D., Dept. of Pharmaceutics, School of Pharmacy, Medical University of Virginia
Peter Gross, M.D., Department of Internal Medicine, Hackensack University Medical Center
Brian L. Strom, M.D., M.P.H., Dept. Biostatistics & Epidemiology, Philadelphia College of Pharmacy
Ruth S. Day, Ph.D., Duke University
Jacqueline Gardner, Ph.D., MPH., Department of Pharmacy University of Washington,
Eric S. Holmboe, M.D., Yale University School of Medicine
William H. Campbell, Ph.D., University of North Carolina at Chapel Hill
Stephanie Y. Crawford, Ph.D., College of Pharmacy University of Illinois at Chicago
Michael R. Cohen, R.Ph., M.S., D.Sc., Institute for Safe Medication Practices
Thomas Fleming, Ph.D., Professor and Chair Department of Biostatistics
Arthur Levin, M.P.H., Center for Medical Consumer & Health Care Information
Guests & Guest Experts (Non-voting)
Carlar Blackman, Center for Functional GI and Motility Disorders, University of North Carolina
Alex Krist, M.D., Dept. of Family Practice, Virginia Commonwealth University
George S. Goldstein, M.D.
John T. Sullivan, M.D.
Open Public Hearing Participants:
Sidney M. Wolfe, M.D. Public Citizen's Health Research Group
Nancy Norton Int. Foundation for Functional GI Disorders
Jeffrey D. Roberts IBS Help Group
Corey Miller Lotronex Action Group
Gary C. Stein, Ph.D. American Society of Health-System Pharmacists
William Brown, Esq.
Julia R. Alberino
Lee & Virginia McLendon
Kathleen Kelly Ghawi
Brenda & Franklin Compton
Dennis K. Larry, Esq.