The U.S. Food and Drug Administration (FDA) currently utilizes information from multiple sources to evaluate the safety of approved medical products. Active medical product surveillance is a new tool that will augment the Agency’s existing postmarket safety assessment process. Numerous issues make communicating active surveillance activities and associated findings challenging.
On November 17, the Engelberg Center for Health Care Reform hosted a one-day expert workshop to discuss issues pertaining to communication of medical product safety surveillance findings. Experts from both the private and public sectors discussed several topics including:
- Current statutory provisions and FDA activities regarding safety and risk communications;
- Stakeholder perspectives on and implications of active surveillance communication strategies (stakeholders included patients, consumers, health care providers, sponsors, data partners, payers, scientists, and media);
- Mechanisms for rapid communication that do not pre-empt journal publications with more complete analyses; and
- Strategies to educate patients, physicians, and other decision makers on how to interpret and apply active surveillance results.
Agenda
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November 17
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Stakeholder Panel III: Scientist and Publisher Perspectives
Richard Platt Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care InstituteChristine Laine Annals of Internal MedicineGref Curfman New England Journal of MedicineDeborah Zarin Lister Hill National Center for Biomedical Communications, National Library of MedicineRobert M. Califf Duke Translational Medicine Institute -
Recap and Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
Welcome and Introduction
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University -
FDA Perspectives on Drug Safety Communications
Joshua M. Sharfstein Vice Dean for Public Health Practice and Community Engagement; Professor of the Practice - Johns Hopkins Bloomberg School of Public Health @drJoshSJulie Zawisza Office of Communications, Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationRachel Behrman Director, Office of Medical Policy, Center for Drug Evaluation and Research -
Stakeholder Panel I: Patient, Consumer, and Health Care Provider Perspectives
Bill Vaughan Consumers UnionMichael McCaughan Prevision Policy LLC and The RPM ReportJean Krause American College of Physicians FoundationTom Menighan American Pharmacists Association -
Stakeholder Panel II: Sponsor, Data Partner, and Payer Perspectives
Stanley B. Watson Kaiser Foundation Research InstituteHeidi Garwood HumanaPatrizia Cavazzoni Pfizer, Inc.David Ceryak Eli Lilly and CompanyBrian Sweet WellPoint, Inc.
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