Excerpt

The Institute of Medicine's (IOM’s) Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007 to consider the types and magnitude of resources needed to implement some of the most resource-intensive recommendations of the [2005] IOM report [The Future of Drug Safety: Promoting and Protecting the Health of the Public]. The symposium’s presentations and discussions were in most cases framed by selected recommendations from the report, and are summarized here in seven key areas:

• addressing the FDA’s resource challenges;
• strengthening the scientific base of the agency;
• integrating pre- and postmarket review;
• enhancing postmarket safety monitoring;
• conducting confirmatory drug safety and efficacy studies;
• enhancing the value of clinical trial registration; and
• enhancing the FDA’s postmarket regulation and enforcement.

Contents

• The National Academies
• Planning Committee for the Symposium on Challenges for the FDA: The Future of Drug Safety
• Forum on Drug Discovery, Development, and Translation
• Reviewers
• Preface
• Summary
  • ADDRESSING THE FDA’S RESOURCE CHALLENGES
  • STRENGTHENING THE SCIENTIFIC BASE OF THE AGENCY
  • INTEGRATING PRE-AND POSTMARKET SAFETY REVIEW
  • ENHANCING POSTMARKET SAFETY MONITORING
  • CONDUCTING CONFIRMATORY DRUG SAFETY AND EFFICACY STUDIES
  • ENHANCING THE VALUE OF CLINICAL TRIAL REGISTRATION
  • ENHANCING POSTMARKET REGULATION AND ENFORCEMENT
  • LOOKING TO THE FUTURE
• 1. Introduction
• 2. Addressing the FDA’s Resource Challenges
  • HISTORICAL OVERVIEW
  • CURRENT FDA FUNDING
  • INDUSTRY USER FEES
  • RESOURCE NEEDS
• 3. Strengthening the Scientific Base of the Agency
  • RESEARCH NEEDED TO IMPROVE DRUG SAFETY: CURRENT FDA INITIATIVES TO EXPAND RESEARCH CAPACITIES
  • BUILDING THE FDA’S CAPACITY FOR SCIENCE-BASED PREMARKET REVIEW
• 4. Integrating Pre- and Postmarket Review
  • OPERATIONAL CHALLENGES TO INITIATING A LIFE-CYCLE APPROACH TO DRUG REVIEW
  • CURRENT INITIATIVES FOR INTEGRATING PRE- AND POSTMARKET REVIEW
• 5. Enhancing Postmarket Safety Monitoring
  • FDA INITIATIVES FOR IMPROVING DRUG SAFETY MONITORING
  • PUBLIC–PRIVATE PARTNERSHIP FOR DEVELOPING A NATIONAL ACTIVE SURVEILLANCE SYSTEM
• 6. Conducting Confirmatory Drug Safety and Efficacy Studies
• 7. Enhancing the Value of Clinical Trial Registration
• 8. Enhancing Postmarket Regulation and Enforcement
  • THE FDA’S REGULATORY AUTHORITY
  • THE FDA’S STATUTORY AUTHORITY
  • PHASE IV COMMITMENTS
  • RESOURCES FOR ENHANCED ENFORCEMENT
  • THE FDA’S REGULATORY AUTHORITY OVER DRUG LABELING
  • PATIENT SAFETY AND ACCESS
  • INDUSTRY PERSPECTIVE
• 9. Looking to the Future
  • PREREQUISITES FOR REVITALIZING THE U.S. DRUG SAFETY SYSTEM
  • THE FUTURE OF DRUG SAFETY REGULATION
• References
• Appendixes
  • Appendix A Workshop Agenda
  • Appendix B Speaker Biographies

Rapporteurs: Leslie Pray and Sally Robinson

Support for this project was provided by the Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and 223-01-2460), American Diabetes Association, American Society for Microbiology, Amgen, Inc., Association of American Medical Colleges, AstraZeneca Pharmaceuticals, Blue Cross Blue Shield Association, Burroughs-Wellcome Fund, Doris Duke Charitable Foundation, Eli Lilly & Co., Entelos, Inc., GlaxoSmithKline, March of Dimes Foundation, Merck & Co., Pfizer Inc., and UnitedHealth Group.

Suggested citation:

Institute of Medicine (IOM). 2007. Challenges for the FDA: The future of drug safety. Workshop summary. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

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.