Institute for the Study of
Healthcare Organizations & Transactions

Nonprescription Drugs Advisory Committee
jointly with
Endocrinologic and Metabolic Drugs Advisory Committee

Food and Drug Administration
Center for Drug Evaluation and Research

Bethesda Holiday Inn, 8120 Wisconsin Avenue, Bethesda MD

July 13-14, 2000

Mevacor« NDA 21-213, lovastatin, 10mg tablets, Merck and Co.
PravacholÔ NDA21-198, pravastatin sodium, 10 mg tablets, Bristol-Myers Squib

Endocrinolog ic and Metabolic Drugs Advisory Committee Consultant:
Robert A. Kreisberg, M.D.
Interim Dean, School of Medicine
University of South Alabama
307 University Boulevard, Rm. 170 CSAB
Mobile, Alabama 36688


Guest Expert:

Luther T. Clark, M.D.
Chief, Division of Cardiovascular Medicine
Health Science Center at Brooklyn
State University of New York
450 Clarkson Avenue, Box 1199
Brooklyn, N.Y. 11203





Bone, Henry G. Ill, M.D               
Michigan Bone and Mineral Clinic
22201 Moross Road
Suite 260
Detroit, Michigan 48236

 Term Expires: 6/30/00



Kathleen R. Reedy
Advisors and Consultants Staff HFD-21
Center for Drug Evaluation and Research
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
301/827-7001 FAX 301/827-6776



Hirsch, Jules, M.D.                        
Sherman Fairchild Professor
Senior Physician
Laboratory of Human Behavoir & Metabolism
The Rockefeller University
1230 York Avenue (Box 181)
New York, New York 10021-6399

Term Expires: 6/30/00


Molitch, Mark F., M.D.                
Professor of Medicine
Northwestern University Medical School
Center for Endocrinology, Metabolism and Molecular Medicine
303 East Chicago Avenue
Tarry Building., Room 15-731
Chicago, Illinois 60611

Term Expires: 6/30/00


Sampson, Allan R., Ph.D.                
Chair, Department of Statistics
University of Pittsburgh
2701 Cathedral of Learning
Pittsburgh, Pennsylvania 15260

Term Expires: 6/30/02


Silverstein, Janet H., M.D.            
Professor of Pediatrics
Chief of Division of Endocrinology
Department of Pediatric Endocrinology
University of Florida
1701 South West 16th Avenue, Room 2126
Gainesville, Florida 32608

Term Expires: 6/30/02


Aoki, Thomas T., M.D.                    
Professor of Medicine, Department of Medicine
Division of Endocrinology
University of California at Davis
4150 V Street, Building PSSB, Room G400
Sacramento, California 95817

Term Expires: 6/30/02


Lukert, Barbara P., M.D.               
Director, Osteoporosis Center
Professor of Medicine
Division of Endocrinology, Department of Medicine
University of Kansas Medical Center
3901 Rainboe Boulevard, 4023 Wescoe
Kansas City, Kansas 66160-7318

 Term Expires: 6/30/02


Gelato, Marie C., M.D., Ph.D.        
Professor of Medicine
Department of Medicine, Division of Endocrinology
SUNY at Stonybrook, Health Science Center
Building T-15, Room 060
Stony Brook, New York 11794-8154

Term Expires: 6/30/03


Grady, Deborah, M.D., M.P.H.        
Professor of Medicine and Epidemiology
Department of Epidemiology
University of California at San Francisco
74 New Montgomery Street, Suite 600
San Francisco, California 94105

Term Expires: 6/30/03


William V. Tamborlane, M.D.        
Professor of Pediatrics
Department of Pediatrics
Yale University School of Medicine
333 Cedar Street
New Haven, Connecticut 06510-8064

Term Expires: 6/30/03


Consumer Representative

Davidson, Jaime A., M.D.            
Endocrine and Diabetes Associates
Medical City Dallas
7777 Forest Lane, Room 445-B
Dallas, Texas 75230  

Term Expires: 6/30/01




Eric P. Brass. M.D., Ph.D.
Chair, Department of Medicine
Harbor-UCLA Medical Center
1000 West Carson Street
Torrance, California 90509
Term Expires: 5/31/01


Sandra Titus, Ph.D.
Advisors and Consultants Staff
5600 Fishers Lane
Rockville, Maryland 20857
301/827-7001 Fax: 301/827-6778
e-mail:TitusS@cder.fda .gov


George A. Blewitt, M.D.
Nonprescription Drug Manufacturers Association
c/o Dr. Lorna Totman
1150 Connecticut Avenue, N.W
Washington, DC 20036
Term Expires: 5/31/01


Richard A. Neill, M.D.
Assistant Professor
Department of Family Practice and Community Medicine
University of Pennsylvania College of Medicine
39th and Market Streets, 615 Mutch Bldg.
Philadelphia, Pennsylvania 19104
Term Expires: 5/31/02

Han C. Sachs, M.D.
Coleman, Coleman and Sachs
11119 Rockville Pike, Suite 310
Rockville, Maryland 20852
Term Expires: 05/31/02

Edward P. Krenzelok, Pharm.D.
Director Pittsburgh Poison Center
Children's Hospital of Pittsburgh
3705 Fifth Avenue
Pittsburgh, Pennsylvania 15213
Term Expires: 05/31/02

Edwin E. Gilliam, Ph.D.
Family Nurse Practitioner
Bone Marrow Transplant Program
University Physician, Inc.
3695 West Sunbright Drive
Tucson, Arizona 85742-1138
Term Expires: 05/31/02

Louis R. Cantilena, Jr., M.D., Ph.D
Director, Division of Clinical Pharmacology
    And Medical Toxicology
Uniformed Services University of the Health Sciences
4301 Jones Bridge Road
Bethesda, Maryland 20814
Term expires: 05/31/04

Julie A. Johnson, Pharm.D.
Associate Professor of Pharmacy Practice
College of Pharmacy, University of Florida
1600 SW Archer Road, Room MG58
Gainesville, Florida 32610
Term Expires: 05/31/04

Y. W. Francis Lam, Pharm.D.
Associate Professor of Pharmacology and Medicine
The University of Texas Health Science Center at San Antonio
7703 Floyd Curl Drive
San Antonio, Texas 78284-6220
Term Expires: 05/31/04

Donald L. Uden, Pharm.D.
Associate Professor of Pharmacy Practice
University of Minnesota
College of Pharmacy
7-159 Weaver-Densford Hall
308 Harvard Street, S.F.
Minneapolis, Minnesota 55455-0343
Term Expires: 05/31/04

Henry W. Williams, Jr., M.D.
Acting Chairman,
Department of Community Health and Family Practice
Howard University College of Medicine
520 W Street, N.W.
Washington, D.C.
Term Expires: 05/31/04