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

______________________________________________________________________________________

 

Womenís 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 Womenís 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