Pharmaceutical & Drug Policy
Incorporating information on therapeutic alternatives into the IRA prescription drug negotiations
On June 13, 2008, the Engelberg Center for Health Care Reform hosted a public forum on prescription drug safety and post-market evidence. This public event included a brief overview of current Food and Drug Administration (FDA) activity concerning drug safety; a discussion of a broad-based approach to generating a distributed data network for post-market evidence; and a review of progress to date on a host of technical, legal, and communications-related challenges identified in the course of our ongoing collaborative work in this area.
Mark McClellan, Director of the Engelberg Center for Health Care Reform and Leonard D. Schaeffer Chair in Health Policy Studies at the Brookings Institution, provided introductory remarks and helped moderate this discussion among many of today’s leading health care policy-makers and analysts.
Read full event summary »
Meeting Materials:
Agenda »
Panelists’ Slide Presentations »
Drug Safety Collaboration Legal Guidance Document »
Sentinel Project Handout »
Agenda
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June 13
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Forum on Drug Safety and Post-Market Evidence
8:30 am - 12:30 pm
The Engelberg Center for Health Care Reform hosted a public forum on prescription drug safety that included a brief overview of current Food and Drug Administration activity as well as progress to date on a host of technical, legal and communications-related challenges identified in the course of the center’s ongoing collaborative work in this area.
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke UniversityAvEAndrew von Eschenbach Commissioner, FDAJWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug AdministrationACArnold Chan OptumInsight Life SciencesGHGigi Hirsch Executive Director, MIT Center for Biomedical InnovationJKJudy Kramer Executive Director of the Clinical Trials Transformation Initiative, Duke UniversitySLSharon Levine Associate Executive Medical Director, Kaiser PermanenteJMJanet Marchibroda Chair, Health Information Technology InitiativeGNGarry Neil Johnson & JohnsonRPRich Platt Harvard Medical School and Harvard Pilgrim Health Care InstituteKBRKristen B. Rosati Coppersmith Schermer & Brockelman PLCLRLee Rucker AARP Public Policy Institute, AARPMDWMarcus D. Wilson President - HealthCore
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke UniversityAvEAndrew von Eschenbach Commissioner, FDAJWJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug AdministrationACArnold Chan OptumInsight Life SciencesGHGigi Hirsch Executive Director, MIT Center for Biomedical InnovationJKJudy Kramer Executive Director of the Clinical Trials Transformation Initiative, Duke UniversitySLSharon Levine Associate Executive Medical Director, Kaiser PermanenteJMJanet Marchibroda Chair, Health Information Technology InitiativeGNGarry Neil Johnson & JohnsonRPRich Platt Harvard Medical School and Harvard Pilgrim Health Care InstituteKBRKristen B. Rosati Coppersmith Schermer & Brockelman PLCLRLee Rucker AARP Public Policy Institute, AARPMDWMarcus D. Wilson President - HealthCore
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