FOOD AND DRUG ADMINISTRATION
Center for Drug Evaluation and Research
ARTHRITIS ADVISORY COMMITTEE (AAC) MEETING
JUNE 23-24, 2003
AGENDA
Versailles
Ballroom, Holiday Inn, Bethesda,
MD
June 23, 2003
8:00 a.m. Call to Order Gary
S. Firestien, M.D.
Chair,
AAC
Introduction of Committee
Conflict of Interest Statement Johanna Clifford, M.S., RN, BSN
Acting
Executive Secretary, AAC
8:15 a.m. Opening Remarks
Discussion
of Fibrolmyalgia, clinical trial design, including
important disease endpoints, in the study and development therapies and
treatments.
Historical Background of Fibromyalgia
8:45 a.m. Pre
ACR Diagnostic Criteria
9:15 a.m. Basic
Mechanisms
9:45 a.m. Post ACR Diagnostic Criteria
10:30
a.m. Break
10:45
a.m. A
Patient’s Perspective
11:00 a.m. Outcomes: Multi-System Impact
11: 30 Open Public Hearing
12:00
p.m. Lunch
1:00 p.m. Charge to Committee
1:30
p.m. Committee
Discussion and Response to FDA Questions
2:30
p.m. Break
4:30 p.m. Adjourn
8:00
a.m. Call to
Order Howard
J. Williams, M.D.
Acting
Chair, AAC
Introduction
of Committee
Conflict
of Interest Statement Johanna
Clifford, M.S., RN, BSN
Acting
Executive Secretary, AAC
Discussion of Enbrel (etanercept)
indicated for reducing the signs and symptoms of ankylosing
spondylitis.
8:15
a.m. Amgen Presentation
Introduction
Assessments in Ankylosing
Spondylitis
Clinical Program and Results
Benefit/Risk Assessment
9:15
am. Questions from the
Committee Sponsor
9:45
a.m. Break
10:00
a.m. FDA Presentation
11:00
a.m. Questions from
the Committee to FDA
11:30
a.m. Open Public
Hearing
12:00
p.m. Lunch
1:00
p.m. Committee
Discussion and Response to FDA Questions
2:00
p.m. Break
2:15
p.m. Continuation of
Committee Discussion and Response to FDA Questions
4:30
p.m. Adjourn