. "Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press, 2007.
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The Future of Drug Safety: Promoting and Protecting the Health of the Public
Appendix D
Committee on the Assessment of the US Drug Safety System Meeting Agendas
MEETING ONE—AGENDA
The National Academies
Institute of Medicine
Committee on the Assessment of the US Drug Safety System
Meeting One
AGENDA
Wednesday, June 8, 2005
OPEN SESSION
Room 100
10:00–10:05 a.m.
Welcome and Introductions
David Blumenthal
Sheila Burke
Co-Chairs, Committee on the Assessment of the
US Drug Safety System
10:05–10:40 a.m.
Charge to the Committee
Steven Galson
Acting Director of the Center for Drug Evaluation and Research
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The Future of Drug Safety: Promoting and Protecting the Health of the Public
Appendix D
Committee on the Assessment of the US Drug Safety System Meeting Agendas
MEETING ONE—AGENDA
The National Academies
Institute of Medicine
Committee on the Assessment of the US Drug Safety System
Meeting One
AGENDA
Wednesday, June 8, 2005
OPEN SESSION
Room 100
10:00–10:05 a.m.
Welcome and Introductions
David Blumenthal
Sheila Burke
Co-Chairs, Committee on the Assessment of the
US Drug Safety System
10:05–10:40 a.m.
Charge to the Committee
Steven Galson
Acting Director of the Center for Drug Evaluation and Research
Food and Drug Administration
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Janet Woodcock
Deputy Commissioner of Operations
Food and Drug Administration
10:35–11:00 a.m.
Questions from the Committee
11:00–11:45 a.m.
Perspectives of Pharmaceutical Manufacturers and Payors
Amit Sachdev
Executive Vice President, Health
Biotechnology Industry Organization (BIO)
Christine Simmon
Vice President of Public Affairs and Development
Generic Pharmaceutical Association (GPhA)
J. Russell Teagarden
Vice President of Clinical Practices & Therapeutics
Medco Health Solutions, Inc. (on behalf of the Pharmaceutical Care Management Association)
Alan Goldhammer
Associate Vice President for Regulatory Affairs
Pharmaceutical Research and Manufacturers of America (PhRMA)
11:45–12:00 p.m.
Questions from the Committee
12:00–12:45 p.m.
Consumer/Patient and Professional Organizations’ Perspectives
David Borenstein
Member, Board of Directors
American College of Rheumatology (ACR)
John A. Gans
Executive Vice-President and Chief Executive Officer
American Pharmacists Association (APhA)
Bill Vaughan
Senior Policy Analyst
Consumers Union
Jeanne Ireland
Director of Public Policy
Elizabeth Glaser Pediatric AIDS Foundation
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12:45–1:00 p.m.
Questions from the Committee
1:00 p.m.
Adjourn
MEETING TWO—AGENDA
The National Academies
Institute of Medicine
Committee on the Assessment of the US Drug Safety System
Meeting Two
AGENDA
Speakers and Times Subject to Change
Tuesday, July 19, 2005
OPEN SESSION
LECTURE ROOM
3:00–3:05 p.m.
Welcome and Introductions
David Blumenthal
Sheila Burke
Co-Chairs, Committee on the Assessment of the US Drug Safety System
3:05–6:00 p.m.
Public Comment
Carla Saxton
Professional Affairs Manager
American Society of Consultant Pharmacists
Maryann Napoli
Center for Medical Consumers
John J. Pippin
Physicians Committee for Responsible Medicine
Patrick J. Madden
Lesley Maloney
American Society of Health-System Pharmacists
Marc Wheat
Chief Counsel and Staff Director
Subcommittee on Criminal Justice, Drug Policy, and Human Resources
US House of Representatives
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Lindsey Johnson
Consumer Advocate
U.S. Public Interest Research Group (US PIRG)
Alison Rein
Assistant Director
Food & Health Policy National Consumers League
Beth A. McConnell
Director
PennPIRG and the PennPIRG Education Fund
Marion J. Goff
Donald Klein
American College of Neuropsychopharmacology
Tom Woodward
Director, Alliance for Human Resource Protection (AHRP)
State Director, International Coalition of Drug Awareness
6:00 p.m.
Adjourn
Wednesday, July 20, 2005
OPEN SESSION
LECTURE ROOM
1:00–1:05 p.m.
Welcome and Introductions
David Blumenthal
Sheila Burke
Co-Chairs, Committee on the Assessment of the US Drug Safety System
1:05–3:00 p.m.
Food and Drug Administration’s (FDA’s) Drug Safety Activities
Introduction and Overview
Paul J. Seligman
Director, Office of Pharmacoepidemiology and Statistical Science
Center for Drug Evaluation and Research
Food and Drug Administration
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Role of the Office of New Drugs in the Safety Assessment
John K. Jenkins
Director of the Office of New Drugs
Center for Drug Evaluation and Research
Food and Drug Administration
The Postmarketing Safety Assessment and the Office of Drug Safety
Anne E. Trontell
Deputy Director, Office of Drug Safety
FDA Center for Drugs
Food and Drug Administration
Future of Safety Assessment
Paul J. Seligman
3:00–3:30 p.m.
Questions from the Committee
3:30–3:45 p.m.
Break
3:45–4:00 p.m.
The Role of the Agency for Healthcare Research and Quality (AHRQ) in the US Drug Safety System
Scott R. Smith
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
4:00–4:15 p.m.
The Role of the Centers for Medicare and Medicaid Services (CMS) in the US Drug Safety System
Speaker TBA
Centers for Medicare and Medicaid Services
4:15–4:45 p.m.
Questions from the Committee
4:45–5:15 p.m.
AHRQ-funded Centers for Education and Research on Therapeutics (CERTs)
and
Contributions of Academia and the Pharmaceutical Industry to Drug Safety Surveillance
Hugh Tilson
Chair, CERTs Steering Committee
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5:15–5:45 p.m.
Questions from the Committee
5:45 p.m.
Adjourn
WORKSHOP—AGENDA
The National Academies
Institute of Medicine
Committee on the Assessment of the US Drug Safety System
Advancing the Methods and Application of Risk-Benefit Assessment of Medicines
January 17, 2006
The Keck Center, Room 100
500 Fifth Street, NW
Washington, DC 20001
Purpose of workshop:
Identify methodological approaches for performing integrated and explicit assessments of risk-benefit of pharmaceuticals throughout a product’s lifecycle, including identifying the type of information that would be most useful to decision-makers.
Obtain expert input on the use of new methodological approaches in pre- and postmarket risk assessment.
Identify opportunities and barriers in advancing a public health approach to balancing risks and benefits of pharmaceuticals for drug regulation and risk management.
Tuesday, January 17, 2005
8:15 a.m.
Opening Remarks
8:30 a.m.
Overview of Pharmacoepidemiology: What Is the Evidence Base?
Session 1: Assessing a product’s risk-benefit balance throughout its lifecycle involves the use of a variety of epidemiological resources and methods, including the use of ad hoc data sources, automated data systems, and randomized trials. The choice of specific assessment methods involves a consideration of many factors, including how well it informs decision making intended to optimize a drug’s balance between benefits and risks.
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Assessing Risks and Benefits of Pharmaceuticals: Methods and Approaches
Brian Strom, MD, MPH
Chair and Professor
Department of Biostatistics and Epidemiology
University of Pennsylvania
Premarket Assessment of Drug Safety at the FDA
Judith Racoosin, MD, MPH
Safety Team Leader
Division of Neurology Products
Division of Psychiatry Products
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
FDA Postapproval Risk Assessment
Anne Trontell, MD, MPH
Senior Advisor on Pharmaceutical Outcomes
Center for Outcomes and Evidence
Agency for Healthcare Policy and Research
Risk-Benefit Frameworks: Perspectives from the Field of Environmental Health
Jonathan Samet, MD, MS
Professor and Chair
Department of Epidemiology
Johns Hopkins School of Public Health
9:45 a.m.
Discussion: Q & A with IOM Committee Members & Audience
10:30 a.m.
Break
11:00 a.m.
Case Studies Involving Risk-Benefit Uncertainties
Session 2: This session involves the consideration of two case studies of contemporary drug safety issues, each case involving a different risk-benefit dilemma. The case studies are intended to focus the discussion on the type of information that would be most useful to decision makers, with the case studies selected to address both the preapproval and the postapproval period. The intent is to model not what is or is not actually done at the FDA and by the industry sponsors, but what could or should be done. The proposed format is that speakers for each case study will briefly present the case study, followed by questions of clarification of fact from the IOM Committee and audience. Following lunch, there will be comments from an invited panel and discussion/questions to be posed by the IOM Committee.
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Presentation of Case Study 1—Salmeterol
Scott T. Weiss, MD
Professor of Medicine
Harvard Medical School
Presentation of Case Study 2—Muraglitazar
Steve Nissen, MD
Medical Director, Cardiovascular Coordinating Center
Cleveland Clinic
Questions of Clarification of Fact
12:30 p.m.
Lunch
1:30 p.m.
Reconvene: Panel Discussions
Suggested Discussion Points for the Panelists: Having heard the case studies, what tool or tools (existing or to be developed) would have narrowed the uncertainty about the benefit/risk profile for the drugs? At what point during evidence development should this tool have been brought into play? What would have remained uncertain? How long would it have taken and what effort would it have taken to reduce that uncertainty? How were the risks and benefits identified, evaluated, and weighted? Where were the flaws in this process? What could have/should have been done differently and why? What resources are needed for your approach? How would this approach improve the current risk/benefit evaluation?
Panel:
Judith K. Jones, MD, PhD
President, The Degge Group, Ltd
Wayne Ray, PhD
Professor, Department of Preventive Medicine
Director, Pharmacoepidemiology
Vanderbilt University
Michael P. Stern, MD
Professor, Department of Medicine
Chief, Division of Clinical Epidemiology
University of Texas, San Antonio
Robert B. Wallace, MD, MS
Professor of Epidemiology, College of Public Health
University of Iowa
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Noel Weiss, MD, PhD
Professor of Epidemiology, School of Public Health and Community Medicine, University of Washington
Discussion: Q & A with IOM Committee Members and Audience
3:00 p.m.
Break
3:30 p.m.
Establishing a framework for risk-benefit methods to reduce uncertainties during pharmacuetical products’s lifecycle
Session 3: This session is designed to session to reflect on what we learned from the case studies and panel discussion and to articulate a framework needed to improve the timing, rigor, and transparency of risk-benefit assessments.
Janice K. Bush, MD
VP, Quality, Education & Business Support, Benefit Risk Management
Curt Furberg, MD, PhD
Professor, Wake Forest University
Louis Garrison, PhD
Professor of Pharmacy, University of Washington
Joanna Haas, MD, MS
Vice President, Pharmacovigilance, Genzyme Corporation
Alastair J.J. Wood, MD
Professor, Vanderbilt University Medical Center
Discussion—All
5:00 p.m.
Adjourn
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MEETING FOUR—AGENDA
The National Academies
Institute of Medicine
Committee on the Assessment of the US Drug Safety System
AGENDA
Thursday, January 19, 2006
OPEN SESSION
Keck 100
8:15–8:25 a.m.
Welcome and Introductions
Description of 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 today’s speakers 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/riskman-agement.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?
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8:25–8:45 a.m.
Geoffrey Levitt
Wyeth Pharmaceuticals
8:45–9:05 a.m.
Steven Ryder
Pfizer, Inc.
9:05–9:25 a.m.
James Kotsanos
Eli Lilly and Company
9:25–9:45 a.m.
James Nickas
Genentech
9:45–10:15 a.m.
Questions from the Committee
10:15–10:30 a.m.
Break
10:30–10:50 a.m.
Fran Visco
National Breast Cancer Coalition
10:50–11:10 a.m.
Sid Wolfe
Public Citizen
11:10–11:30 a.m.
Frank Burroughs
Steve Walker
Abigail Alliance for Better Access to Developmental Drugs
11:30–11:50 a.m.
David H. Campen
Kaiser Permanente (on behalf of America’s Health Insurance Plans)
11:50 a.m.–12:20 p.m.
Questions from the Committee
12:20–12:30 p.m.
Closing Remarks
12:30 p.m.
Adjourn
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