FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Cardiovascular and Renal Drugs Advisory Committee

Holiday Inn Gaithersburg

Two Montgomery Village Avenue, Gaithersburg, MD

AGENDA

June 15, 2005

The committee will discuss class labeling of antihypertensive drugs based on the proximity of their data to outcome trials

8:00 Call to Order and Introductions Steven E. Nissen, M.D.

Committee Chair

Cardiovascular and Renal Drugs Advisory Committee

Conflict of Interest Statement LT Cathy Groupe, B.S.N.

Executive Secretary

Cardiovascular and Renal Drugs Advisory Committee

8:15 Welcome Norman Stockbridge, M.D.

Recognition of Retiring Acting Director

Cardiovascular and Renal Drugs Division of Cardiovascular and Renal Drug Products

Advisory Committee members FDA Center for Drug Evaluation and Research

FDA Review Division Presentation:

8:30 Introduction Robert J. Temple, M.D.

Acting Director

Office of Drug Evaluation I

FDA Center for Drug Evaluation and Research

8:45 Applicable Outcomes Claims Stephen W. MacMahon, B.Sc., Ph.D., M.P.H., F.A.C.C.

For Antihypertensive Drugs Principal Director

Professor of Cardiovascular Medicine and Epidemiology

The George Institute for International Health

The University of Sydney

9:00 Differences in Outcomes Claims Stephen W. MacMahon, B.Sc., Ph.D., M.P.H., F.A.C.C.

For Different Drug Classes

9:15 Deciding Whom to Treat Jay N. Cohn, M.D.

For Hypertension Professor of Medicine and Director

Rasmussen Center for Cardiovascular Disease Prevention University of Minnesota

FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Cardiovascular and Renal Drugs Advisory Committee

AGENDA

June 15, 2005

Page 2

9:45 When to Initiate Successive Henry R. Black, M.D.

Antihypertensive Drugs Chairman and Associate Vice President for Research

Rush University Medical Center

10:00 Can One Sustain an Outcome

Claim Based on an Active

Controlled Study?

Introduction Lance Berman, MD

Medical Director – U.S. Team Leader

Pfizer, Inc.

Methodology and Analysis Michael Gaffney, Ph.D.

[Overview] Senior Director – Statistical Research and Consulting

Pfizer, Inc.

10:15 Break

10:30 Does the Pattern of Blood Thomas G. Pickering, M.D., Ph.D., F.R.C.P.

Pressure Effects During the Director – Integrative and Behavioral Cardiology Program

Day Matter? The Zena and Michael A. Wiener Cardiovascular Institute

Mount Sinai Medical Center

10:45 Does the Benefit Associated with Ronald J. Portman, M.D.

Treating Hypertension Apply to Professor of Pediatrics and Director of the Division

Children? Pediatric Nephrology and Hypertension

University of Texas – Houston Medical School

11:00 Committee Discussion

12:00 Lunch

1:00 Open Public Hearing

2:00 Committee Discussion and Questions

3:00 Break

3:15 Committee Discussion and Questions [Continued]

5:00 Adjournment