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Institute of Medicine reports: The Future of Drug Safety
Triggered by the Vioxx recall but addressing a number of problems in the function of the Food and Drug Administration (FDA) the Institute of Medicine (part of the National Academy of Sciences) completed its 15 month analysis on September 22, 2006.
The Future of Drug Safety: Promoting and Protecting the Health of the Public
The major problems were matters of drug safety, rather than innovation or the speed of getting new drugs to market.
Areas in which improvement was needed, in their words:
- Credibility of FDA and of the pharmaceutical industry.
- Serious resource constraints
- Suboptimal organizational culture
- Unclear and insufficient regulatory authorities particularly with respect to enforcement.
- Insufficient accountability and transparency to the public
- Timely and effective communication of safety concerns
Beyond Phase III clinical trials, the study cites the need to monitoring of drug safety post-marketing and for longer durations of administration.
Could a new era in toxicology be on the horizon?
The report The Future of Drug Safety can be read online here, or purchased.
Table of Contents
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Front Matter i-x
Report Summary 1-14 (skim)
1 Introduction 15-26 (skim)
2 Natural History of a Drug 27-54 (skim)
3 A Culture of Safety 55-84 (skim)
4 The Science of Safety 85-120 (skim)
5 Regulatory Authorities for Drug Safety 121-140 (skim)
6 Communicating About Safety 141-152 (skim)
7 Resources for the Drug Safety System 153-162 (skim)
Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States 163-172 (skim)
Appendix B Acronyms 173-174 (skim)
Appendix C PDUFA Goals 175-204 (skim)
Appendix D Meeting Agendas 205-216 (skim)
Appendix E Summary, IOM Report: Preventing Medication Errors 217-236 (skim)