DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
National Institutes of Health
9000 Rockville Pike
Building 10, Clinical Center
Jack Masur Auditorium
CARDIOVASCULAR AND RENAL DRUGS ADVISORY COMMITTEE
May 24, 25, 2001
Thursday, May 24, 2001
8:30 a.m. Open Public Hearing:
Sidney M. Wolfe, M.D., Director, Public Citizenís Health Research Group (15 minutes)
Edward J. Parr Jr. Esq. : Comments Franz H. Messerli, M.D. (10 minutes)
9:00 a.m. Response to Citizenís petition of Lawrence D. Bernhardt and Arnold Liebman, regarding NDA 19,668, Cardura, (doxazosine), Pfizer Inc..
Introduction: Salvatore J. Graziano, Milberg Weiss Bershad Hynes & Lerach LLP
Dr. L. Krakoff, Englewood Hospital (20 minutes)
Published interim analyses of ALLHAT (Antihypertensive and Lipid Lowering treatment to prevent Heart Attack Trial) NIH, NHLBI.:
Jeffrey A. Cutler M.D., M.Ph, Director Clinical Application and Prevention Program, NHLBI, NIH (20 minutes)
Pfizerís Response to ALLHAT:
Doxazosin Data Review: Clinical Trials, Literature Review
Non-Clinical Trial Post-Approval Experience
Pfizer Comments on ALLHAT
Suzanne LoGalbo, R.Ph., J.D., Director/Team Leader Regulatory Affairs
Patricia Walmsley, MB, FRCPath, Senior Medical Director, Doxazosin Worldwide Team
Gretchen Dieck, Ph.D., Sr. Epidemiologist, Safety Evaluation and Epidemiology(20 minutes)
10:00 a,m, Break
10:15 a.m. Committee Questions and Discussion:
12:15 p.m. Lunch
1:15 p.m. Committee Questions, Discussion and Recommendations:
Committee Reviewer: Thomas Fleming, Ph.D.
5:00 p.m. Adjourn
FDA Invited Guests:
Temporary Voting Members:
Dr. R. DíAgostino, Boston University
Dr. R. Fenichel, Wahington, D.C.
Dr. M. Konstam, New England Medical Center
Dr. B. Davis, University of Texas, Houston HSC, Director of ALLHAT Clinical Trials Center
May 25, 2001, 9:00a.m.
Natrecor NDA-20-920 (nesiritide) for treatment of acute heart failure, Scios Inc.
Introduction: Michael Crockett, Scios Inc.
Original NDA 20-920: R. Lipicky, M.D., Director, Division of Cardiorenal Drug Products
NDA Amendment Trial Designs: D.P. Horton, M.D., Scios Inc.
VMAC Efficacy: J. B. Young, M.D., Cleveland Clinic Foundation
Natrecor Safety, D.P. Horton, M.D., Scios Inc.
Benefit/Risk Assessment: W.T. Abraham, M.D., University of Kentucky, College of Medicine
11:30 a.m.: Break
12:00p.m.: Committee Discussion and Questions:
Committee Reviewer: Ileana Pina, M.D.
FDA Invited Guests and Temporary Voting Members:
Ralph DíAgostino, Ph.D., Boston University
Marvin Konstam, M.D., New England Medical Center