FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH (CDER)
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.
Division of Metabolic and Endocrine
Drug Products, FDA
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.
Open Public Hearing
Criteria of effectiveness and safety Eric Colman, M.D.
in the evaluation of osteoporosis drug products Division of Endocrinologic and Metabolic Drugs, FDA
Overview of the Women’s Health Initiative (WHI) Jacques Rossouw, MD
Marcia Stefanick, Ph.D.
WHI at Harbor-UCLA
WHI Presentations Cont.
Osteoporosis Jane Cauley, DrPH
Garnet Anderson, Ph.D.
Future Clinical Trials Jacques Rossouw, MD
Questions from the Committee
Presentation by Wyeth Pharmaceuticals
Questions from the committee
FDA Presentation Bruce Stadel, M.D., MPH
Eric Colman, M.D.
Charge to the Committee David Orloff, M.D.