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The Future of Drug Safety: Promoting and Protecting the Health of the Public (2007)

Chapter: Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas

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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
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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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

 

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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

 

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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

 

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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

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:

  1. 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.

  2. Obtain expert input on the use of new methodological approaches in pre- and postmarket risk assessment.

  3. 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.

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

 

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.

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

 

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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

 

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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

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:

 

 

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?

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

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

Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×

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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
Page 263
Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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Suggested Citation:"Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas." Institute of Medicine. 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: The National Academies Press. doi: 10.17226/11750.
×
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In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' risk–benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.

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