Communicating Findings from Active Medical Product Surveillance
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
Stakeholder Panel III: Scientist and Publisher Perspectives
Richard Platt
Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute
Christine Laine
Annals of Internal Medicine
Gref Curfman
New England Journal of Medicine
Deborah Zarin
Lister Hill National Center for Biomedical Communications, National Library of Medicine
Robert 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
Julie Zawisza
Office of Communications, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
Rachel 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 Union
Michael McCaughan
Prevision Policy LLC and The RPM Report
Jean Krause
American College of Physicians Foundation
Tom Menighan
American Pharmacists Association
Stakeholder Panel II: Sponsor, Data Partner, and Payer Perspectives
Stanley B. Watson
Kaiser Foundation Research Institute
Heidi Garwood
Humana
Patrizia Cavazzoni
Pfizer, Inc.
David Ceryak
Eli Lilly and Company
Brian Sweet
WellPoint, Inc.
More Information
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