Meeting Four
January 19, 2006
8:15a.m. - 12:30p.m.

Location:
Institute of Medicine
Keck Center, Room 100
500 5th Street, NW
Washington, DC 20001

Committee’s request to invited speakers:

Many recommendations for strengthening FDA’s role in drug safety have been made in the past several years. We have sent the speakers for this meeting three sets of recommendations:

• Ganslaw LS. 2005. Drug Safety: New Legal/Regulatory Approaches. FDLI Update: Food and Drug Law, Regulation, and Education
• FDA Task Force on Risk Management. 1999. Managing the Risks from Medical Product Use: Creating a Risk Management Framework. Report to the FDA Commissioner from the Task Force on Risk Management. http://www.fda.gov/oc/tfrm/riskmanagement.pdf
• CRS/Thaul. 2005. Drug Safety and Effectiveness: Issues and Action Options After FDA Approval. http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RL3279703082005.pdf

• Which of these or other recommendations are the most important to consider and why?
• Which of these or other recommendations that have been made would you not support and why?
  

AGENDA

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8:15 a.m. – 8:25 a.m.
Welcome and Introductions

Audio File for first half of the meeting

Audio File for second half of the meeting

8:25 a.m. – 8:45 a.m.
Geoffrey Levitt
Wyeth Pharmaceuticals

8:45 a.m. – 9:05 a.m.
Steven Ryder
Pfizer, Inc

9:05 a.m. – 9:25 a.m.
James Kotsanos
Eli Lilly and Company

9:25 a.m. - 9:45 a.m.
James Nickas
Genentech
PowerPoint Presentation

9:45 a.m. – 10:15 a.m.
Questions from the Committee

10:15 a.m. – 10:30 a.m.
Break

10:30 a.m. – 10:50 a.m.
Fran Visco
National Breast Cancer Coalition

10:50 a.m. – 11:10 a.m.
Sid Wolfe
Public Citizen

11:10 a.m. – 11:30 a.m.
Frank Burroughs & Steve Walker
Abigail Alliance for  Better Access to Developmental Drugs
PowerPoint Presentation

11:30 a.m. – 11:50 p.m.
David H. Campen
Kaiser Permanente
Representative from America’s Health Insurance Plans
PowerPoint Presentation

11:50 p.m. – 12:20 p.m.
Questions from the Committee

12:20 p.m. - 12:30 p.m.
Closing Remarks

12:30 p.m.
Adjourn