The Future of Drug Safety

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. Table of Contents Front Matter Summary 1 Introduction 2 Natural History of a Drug 3 A Culture of Safety 4 The Science of Safety 5 Regulatory Authorities for Drug Safety 6 Communicating About Safety 7 Resources for the Drug Safety System Appendix A Moving Target--The Shifting Landscape of Drug Safety in the United States Appendix B Acronyms Appendix C PDUFA Performance Goals-All Years Appendix D Committee on the Assessment of the US Drug Safety System Meeting Agendas Appendix E Summary: Preventing Medication Errors: Quality Chasm Series, Institute of Medicine Appendix F Committee Biographies Index