Mar 8

Past Event

Legal Issues in Active Medical Product Surveillance

Summary

The Engelberg Center for Health Care Reform at Brookings hosted a small expert workshop to discuss legal issues in the development and implementation of FDA’s Sentinel Initiative for medical product safety surveillance.

The one-day workshop featured productive discussion and exchange of ideas with panelists representing government, academia, and the private sector on topics including:

  • Protecting patient privacy in medical product safety surveillance;
  • Appropriate human-subject protections for research use of Sentinel System data; and
  • Addressing legal liability in medical product safety surveillance.

Details

March 8, 2010

8:30 AM - 3:45 PM EST

Washington Marriott at Metro Center

Grand Ballroom

775 12th St. NW

Map

For More Information

Engelberg Center for Health Care Reform

(202) 797-4391

Event Agenda

  • Welcome, Introduction, and Meeting Objectives

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies

  • The Sentinel Initiative

    • Rachel E. Behrman

      Center for Drug Evaluation and Research, Food and Drug Administration

  • Panel 1: Scientific and Data Needs for Active Medical Product Surveillance in the Near and Longer Terms

    • Richard Platt

      Department of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute

    • Paul Stang

      Johnson & Johnson and Observational Medical Outcomes Partnership

    • Judy Racoosin

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

  • Panel 2: Protecting Patient Privacy in Medical Product Safety Surveillance

    • Kristen B. Rosati

      Coppersmith Schermer & Brockelman PLC

    • Deven McGraw

      Health Privacy Project, Center for Democracy and Technology

    • Joy Pritts

      Office of the National Coordinator for Health Information Technology, HHS

    • Donald O. Beers

      Office of Chief Counsel, Food and Drug Administration

  • Panel 3: Appropriate Human-Subject Protections for Research Use of Sentinel System Data

    • Barbara Evans

      Health Law & Policy Institute and Center for Biotechnology & Law, University of Houston

    • Jerry Menikoff

      Office for Human Research Protections, HHS

    • Kenneth W. Goodman

      University of Miami Bioethics Program

    • Laura Youngblood

      National Center for Emerging and Zoonotic Infectious Diseases, Centers for Disease Control and Prevention

    • Kate Cook

      Office of the Center Director, Center for Biologics Evaluation and Research, Food and Drug Administration

  • Panel 4: Addressing Legal Liability in Medical Product Safety Surveillance

    • Kristen B. Rosati

      Coppersmith Schermer & Brockelman PLC

    • Stanley Watson

      Kaiser Foundation Research Institute

    • Heidi Garwood

      Humana

    • Dan Troy

      GlaxoSmithKline

  • Recap and Closing Remarks

    • mmclellanimage

      Mark B. McClellan

      Director

      Economic Studies