Past Event

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

P

Richard Platt

Professor and Chair, Department of Population Medicine - Harvard Pilgrim Health Care Institute

L

Deborah Zarin

Lister Hill National Center for Biomedical Communications, National Library of Medicine

Recap and Closing Remarks

Welcome and Introduction

FDA Perspectives on Drug Safety Communications

O

Julie Zawisza

Office of Communications, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

D

Rachel Behrman

Director, Office of Medical Policy, Center for Drug Evaluation and Research

Stakeholder Panel I: Patient, Consumer, and Health Care Provider Perspectives

Stakeholder Panel II: Sponsor, Data Partner, and Payer Perspectives

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