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 |
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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 |
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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 |
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Amit Sachdev Executive Vice President, Health Biotechnology Industry Organization (BIO) |
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Christine Simmon Vice President of Public Affairs and Development Generic Pharmaceutical Association (GPhA) |
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J. Russell Teagarden Vice President of Clinical Practices & Therapeutics Medco Health Solutions, Inc. (on behalf of the Pharmaceutical Care Management Association) |
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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 |
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David Borenstein Member, Board of Directors American College of Rheumatology (ACR) |
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John A. Gans Executive Vice-President and Chief Executive Officer American Pharmacists Association (APhA) |
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Bill Vaughan Senior Policy Analyst Consumers Union |
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Jeanne Ireland Director of Public Policy Elizabeth Glaser Pediatric AIDS Foundation |
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 |
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David Blumenthal Sheila Burke Co-Chairs, Committee on the Assessment of the US Drug Safety System |
3:05–6:00 p.m. |
Public Comment |
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Carla Saxton Professional Affairs Manager American Society of Consultant Pharmacists |
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Maryann Napoli Center for Medical Consumers |
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John J. Pippin Physicians Committee for Responsible Medicine |
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Patrick J. Madden Lesley Maloney American Society of Health-System Pharmacists |
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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) |
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Alison Rein Assistant Director Food & Health Policy National Consumers League |
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Beth A. McConnell Director PennPIRG and the PennPIRG Education Fund |
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Marion J. Goff Donald Klein American College of Neuropsychopharmacology |
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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 |
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Introduction and Overview |
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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 |
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John K. Jenkins Director of the Office of New Drugs Center for Drug Evaluation and Research Food and Drug Administration |
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The Postmarketing Safety Assessment and the Office of Drug Safety |
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Anne E. Trontell Deputy Director, Office of Drug Safety FDA Center for Drugs Food and Drug Administration |
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Future of Safety Assessment |
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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 |
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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 |
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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) |
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and |
Contributions of Academia and the Pharmaceutical Industry to Drug Safety Surveillance |
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Hugh Tilson Chair, CERTs Steering Committee |
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:
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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.
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Obtain expert input on the use of new methodological approaches in pre- and postmarket risk assessment.
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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 |
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Brian Strom, MD, MPH Chair and Professor Department of Biostatistics and Epidemiology University of Pennsylvania |
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Premarket Assessment of Drug Safety at the FDA |
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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 |
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FDA Postapproval Risk Assessment |
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Anne Trontell, MD, MPH Senior Advisor on Pharmaceutical Outcomes Center for Outcomes and Evidence Agency for Healthcare Policy and Research |
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Risk-Benefit Frameworks: Perspectives from the Field of Environmental Health |
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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 |
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Scott T. Weiss, MD Professor of Medicine Harvard Medical School |
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Presentation of Case Study 2—Muraglitazar |
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Steve Nissen, MD Medical Director, Cardiovascular Coordinating Center Cleveland Clinic |
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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? |
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Panel: |
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Judith K. Jones, MD, PhD President, The Degge Group, Ltd |
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Wayne Ray, PhD Professor, Department of Preventive Medicine Director, Pharmacoepidemiology Vanderbilt University |
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Michael P. Stern, MD Professor, Department of Medicine Chief, Division of Clinical Epidemiology University of Texas, San Antonio |
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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 |
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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. |
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Janice K. Bush, MD VP, Quality, Education & Business Support, Benefit Risk Management |
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Curt Furberg, MD, PhD Professor, Wake Forest University |
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Louis Garrison, PhD Professor of Pharmacy, University of Washington |
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Joanna Haas, MD, MS Vice President, Pharmacovigilance, Genzyme Corporation |
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Alastair J.J. Wood, MD Professor, Vanderbilt University Medical Center |
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Discussion—All |
5:00 p.m. |
Adjourn |
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 |
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Description of Committee’s request to invited speakers |
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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: |
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Reflecting on these (and other recommendations you find relevant) please comment on the following: |
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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 |