Meeting Agenda

Drug Safety: Meeting Four: Agenda for January 19th

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

Reflecting on these (and other recommendations you find relevant) please comment on the following:

• 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
  

  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

  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

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

  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
  

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