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Nov 17

Past Event

Communicating Findings from Active Medical Product Surveillance

Event Materials


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.

Event Agenda

  • Welcome and Introduction

  • FDA Perspectives on Drug Safety Communications

    • Joshua Sharfstein

      U.S. Food and Drug Administration

    • Julie Zawisza

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

    • Rachel Behrman

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

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

    • Bill Vaughan

      Consumers Union

    • Marc Boutin

      National Health Council

    • Michael McCaughan

      The RPM Report and Prevision Policy LLC

    • Jean Krause

      American College of Physicians Foundation

    • Tom Menighan

      American Pharmacists Association

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

    • Stanley Watson

      Kaiser Foundation Research Institute

    • Heidi Garwood


    • Patrizia Cavazzoni

      Pfizer, Inc.

    • David Ceryak

      Eli Lilly and Company

    • Brian Sweet

      WellPoint, Inc.

  • Stakeholder Panel III: Scientist and Publisher Perspectives

    • Richard Platt

      Harvard Medical School and 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 Califf

      Duke Translational Medicine Institute and Duke University Medical Center

  • Recap and Closing Remarks


November 17, 2010

8:30 AM - 3:00 PM EST

The Brookings Institution

Saul/Zilkha Rooms

1775 Massachusetts Avenue, NW


For More Information

Engelberg Center for Health Care Reform

(202) 797-4391

SERIES: Expert Workshops | Number 6