Like many other agencies of the federal government, the Food and Drug Administration (FDA) relies extensively on external advisory committees for independent scientific and technical advice.

Recognizing that the existing advisory committee system is essentially sound, this volume recommends ways of enhancing the use of these committees in the evaluation of drugs, biological materials, and medical devices; strengthening the agency's management of the system; and increasing the accountability of the system to the public.

In doing so, it examines and makes recommendations on such issues as the recruitment of committee members, the FDA's management of financial conflict of interest and intellectual bias among members, and the operations and management of the advisory committee system.

Contents

• Committee to Study the Use of Advisory Committees by the Food and Drug Administration
• Preface
• Acknowledgments
• List of Abbreviations
• Summary
• 1. Introduction
  • Origins of the Study
  • Study Objectives
  • Scope of the Study
  • The Roles of FDA Advisory Committees
  • Practical Limits on the Use of Advisory Committees
  • The Federal Advisory Committee Act
  • Study Methods
  • Report Organization
  • A Note on Cross-National Comparisons
  • Appendix
• 2. Historical Evolution of FDA Advisory Committees
  • Drugs
  • Biologics
  • Medical Devices
  • NIH Study Sections
  • Summary
• 3. The FDA Advisory Committee System
  • The Product Evaluation Process
  • Agency Workload and Advisory Committees
  • Official Purposes of Advisory Committees
  • The Uses of Advisory Committees
  • Summary
• 4. Recurring Issues
  • Major Prior Reports
  • The Goldfish Bowl
  • Conclusions
• 5. Committee Membership
  • Nomination Criteria
  • Recruitment Procedures
  • Consumer Members
  • Appointment Authority
  • Administrative Responsibility for Appointments
• 6. Ensuring Committee Integrity
  • Financial Conflict of Interest
  • The Statutory Framework
  • FDA's Administration of Conflict-of-Interest Restrictions
  • A Rapidly Changing System
  • Recommendations on Financial Conflict of Interest
  • Intellectual Bias
  • Screening
  • Appendix
• 7. Committee Operations
  • Scheduling Advisory Committee Meetings
  • Meeting Preparation
  • Conducting an Advisory Committee Meeting
  • Custom Tailoring of Committee Membership
  • Meeting Follow-up
• 8. Organization and Management
  • System Management
  • Compensation
  • Orientation and Training
  • Types of Advisory Committees
  • Agency Management and Accountability
  • A Concluding Recommendation
• Appendix A Resource Implications
• Appendix B Glossary

Support for this project was provided by the Food and Drug Administration pursuant to Contract No. 223-91-8050.

NOTICE: The project that is the subject of this report was approved by the governing board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competencies and with regard to appropriate balance.

This report has been reviewed by a group other than the authors according to procedures approved by a report review committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this the Institute acts under both the Academy's 1863 congressional charter responsibility to be an advisor to the federal government and its own initiative in identifying issues of medical care, research, and education.