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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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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The Future of Drug Safety: Promoting and Protecting the Health of the Public 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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