FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)

Endocrinologic and Metabolic Drugs Advisory Committee Meeting

October 7, 2003

Holiday Inn, Versailles Ballroom, Bethesda, MD

DRAFT AGENDA

8:00 a.m. Call to Order and Introductions Michael McClung, M.D.

Acting Chair, Endocrinologic and Metabolic Drugs Advisory Committee, EMDAC

Conflict of Interest Statement Dornette Spell-LeSane, M.H.A., NP-C

Executive Secretary, EMDAC

Welcome and Introductory Comments David Orloff, M.D.

Director

Division of Metabolic and Endocrine

Drug Products, FDA

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Women’s Health Initiative Study Results: Implications for the use of hormone therapy with estrogen/progestin as a second-line drug for the prevention and treatment of postmenopausal osteoporosis in women.

8:15 Open Public Hearing

9:15 FDA Presentation

Criteria of effectiveness and safety Eric Colman, M.D.

in the evaluation of osteoporosis drug products Division of Endocrinologic and Metabolic Drugs, FDA

9:30 WHI Presentations

Overview of the Women’s Health Initiative (WHI) Jacques Rossouw, MD

NHLBI

Marcia Stefanick, Ph.D.

Stanford Center for research in

Disease Prevention

WHI Presentations Cont.

Interpretation of breast cancer results Rowan Chelebowski, M.D.

WHI at Harbor-UCLA

Garnet Anderson, Ph.D

Fred Hutchinson Cancer Research Center

10:15 Break

10:30 WHI Presentations Cont.

Osteoporosis Jane Cauley, DrPH

University of Pittsburgh

Garnet Anderson, Ph.D.

Future Clinical Trials Jacques Rossouw, MD

11:30 Questions from the Committee

12:00 Lunch

1:00 Presentation by Wyeth Pharmaceuticals

2:00 Questions from the committee

2:30 FDA Presentation Bruce Stadel, M.D., MPH

Eric Colman, M.D.

3:00 Break

3:15 Charge to the Committee David Orloff, M.D.

3:30 Committee Discussion

5:00 Adjourn