Food and Drug Administration advisory committees / Committee to Study the Use of Advisory Committees by the Food and Drug Administration ; Richard A. Rettig, Laurence E. Earley, Richard A. Merrill, editors.

Format:

Book

Author/Creator:

Institute of Medicine (U.S.). Committee to Study the Use of Advisory Committees by the Food and Drug Administration.

Contributor:

Rettig, Richard A.

Earley, Laurence E.

Merrill, Richard A.

Institute of Medicine (U.S.). Division of Health Sciences Policy.

Language:

English

Subjects (All):

Institute of Medicine (U.S.). Committee to Study the Use of Advisory Committees by the Food and Drug Administration.

Institute of Medicine (U.S.).

Public health advisory groups--United States--Evaluation.

Public health advisory groups.

Physical Description:

xii, 226 p. : ill.

Edition:

1st ed.

Place of Publication:

Washington, D.C. : National Academy Press, 1992.

Language Note:

English

Summary:

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:

Food and Drug Administration Advisory Committees

Copyright

Preface

NOTES

Acknowledgments

Contents

List of Abbreviations

Summary

The Roles of FDA Advisory Committees

Practical Limits on Advisory Committees

COMMITTEE MEMBERSHIP

Nomination Criteria

Recruitment Procedures

Consumer Members

Appointment Authority

Administrative Responsibility for Appointments

COMMITTEE INTEGRITY

Options Requiring Legislation

Options Available within Existing Authority

COMMITTEE OPERATIONS

Scheduling Meetings

Meeting Preparation

General Criteria for Setting the Agenda

Setting Specific Agendas

Timely Distribution of Materials

Summaries of Materials Sent to Advisory Committees

Use of Primary Reviewers

Communications Issues

Conducting an Advisory Committee Meeting

Allocation and Control of Agenda Time

Electronic Coverage of Meetings

Voting

Agency Neutrality

Custom Tailoring of Committee Membership

Meeting Follow-up

ORGANIZATION AND MANAGEMENT

System Management

Compensation

Orientation and Training

AGENCY MANAGEMENT AND ACCOUNTABILITY

Agency Management

Agency Accountability

A CONCLUDING RECOMMENDATION

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-NATINOAL COMPARISONS

APPENDIX

NOTE

2 Historical Evolution of FDA Advisory Committees

DRUGS

Drug Efficacy Study

Over-the-Counter Drugs

Prescription Drug Review

BIOLOGICS

MEDICAL DEVICES

The Cooper Report

The Medical Device Amendments of 1976

NIH STUDY SECTIONS

SUMMARY

3 The FDA Advisory Committee System.

THE PRODUCT EVALUATION PROCESS

The Drug Evaluation Process

The Biologics Approval Process

The Device Approval Process

AGENCY WORKLOAD AND ADVISORY COMMITTEES

OFFICIAL PURPOSES OF ADVISORY COMMITTEES

The FDA Regulations

The NDA Rewrite

Medical Device Statutes

FDA Advisory Committee Charters

THE USES OF ADVISORY COMMITTEES

Variations Among Centers

Center Workload and Stage of Advisory Committee Use

Other Means of Seeking Advice

4 Recurring Issues

MAJOR PRIOR REPORTS

The Fountain Committee Report (1976)

The Dorsen Committee Report (1977)

The McMahon Commission Report (1982)

The Lasagna Committee Report (1990)

Other Reports

THE GOLDFISH BOWL

Congressional Oversight

Media Coverage

The Financial Community

CONCLUSIONS

5 Committee Membership

NOMINATION CRITERIA

General and Specific Criteria

Diversity Objectives

Balance

Implications

RECRUITMENT PROCEDURES

CONSUMER MEMBERS

APPOINTMENT AUTHORITY

ADMINISTRATIVE RESPONSIBILITY FOR APPOINTMENTS

6 Ensuring Committee Integrity

FINANCIAL CONFLICT OF INTEREST

THE STATUTORY FRAMEWORK

Subsection 208(b)(1)

Subsection 208(b)(2)

Subsection 208(b)(3)

FDA'S ADMINISTRATION OF CONFLICT-OF-INTEREST RESTRICTIONS

Screening Potential Committee Members

Identification of Conflict and Decision to Seek a Waiver

A RAPIDLY CHANGING SYSTEM

Notable Controversies

Psychopharmaceutical Drugs Advisory Committee: Meeting of September20, 1991

General and Plastic Surgery Devices Advisory Panel: Meeting of November12-13, 1991

Arthritis Drugs Advisory Committee: Meeting of December 6, 1991

Blood Products Advisory Committee Meeting: December 12-13, 1991

Biologics Response Modifiers Advisory Committee: Meeting of January 16-17, 1992.

Dermatologic Drugs Advisory Committee: Meeting of April 10, 1992

Circulatory Systems Devices Panel: Meeting of May 11, 1992

Analysis of Waiver Processing

Interpretation

Glimmers of Progress

Workload

Waiver Preparation and Review

Schedule for Review of Waivers

Waiver Form

RECOMMENDATIONS ON FINANCIAL CONFLICT OF INTEREST

Options Available Within Existing Authority

INTELLECTUAL BIAS

Remedies

Screening

A Suggested Approach to the Codification of Section 208(b)(3) Waiver Criteria

7 Committee Operations

SCHEDULING ADVISORY COMMITTEE MEETINGS

MEETING PREPARATION

Product Evaluation and Guidelines Development at CDER

Program Management at CDER

Setting the Agenda

Content of the Agenda Questions

Summaries of Materials Sent to the Committee

Communications Issues Before an Advisory Committee Meeting

FDA Communication to Advisory Committee Members

Communication Among Advisory Committee Members

Communication Between Sponsors and Advisory Committee Members

Agency Communication to Sponsors

Communication Between the FDA and the Public

CONDUCTING AN ADVISORY COMMITTEE MEETING

Roles of the Principal Participants

Agency Presentations

FDA-Committee Interaction

Seating Arrangements

Closed Deliberations

CUSTOM TAILORING OF COMMITTEE MEMBERSHIP

MEETING FOLLOW-UP

8 Organization and Management

SYSTEM MANAGEMENT

The Commissioner and His Office

Center Directors

Office and Division Directors

Executive Secretaries

COMPENSATION

ORIENTATION AND TRAINING.

TYPES OF ADVISORY COMMITTEES

Policy Advisory Committee

Other Issues

Appendix A Resource Implications

CURRENT SYSTEM COSTS UNDERESTIMATED

RECOMMENDATIONS THAT WILL HAVE RESOURCE IMPLICATIONS

Appendix B Glossary.

Notes:

"Division of Health Care [sic] Policy, Institute of Medicine."

Includes bibliographical references.

ISBN:

9786610246861

9781280246869

1280246863

9780309585200

0309585201

9780585085500

0585085501

OCLC:

923262665