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Office of Drug Safety Updates Drug Safety and Risk Management Advisory Committee Meeting February 10, 2006

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Drug Safety and Risk Management Advisory Committee Meeting February 10, 2006 Gerald J. Dal Pan, MD, MHS Director, Office of Drug Safety US Food and Drug Administration – PowerPoint PPT presentation

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Title: Office of Drug Safety Updates Drug Safety and Risk Management Advisory Committee Meeting February 10, 2006


1
Office of Drug Safety UpdatesDrug Safety and
Risk Management Advisory Committee
MeetingFebruary 10, 2006
  • Gerald J. Dal Pan, MD, MHS
  • Director, Office of Drug Safety
  • US Food and Drug Administration

2
Office Leadership
  • Director
  • Gerald Dal Pan, MD, MHS
  • Acting Deputy Director
  • Jonca Bull, MD

3
Division Leadership
  • Division of Drug Risk Evaluation
  • Mark Avigan, MD, CM, Director
  • Rosemary Johann-Liang, MD Deputy Director
  • Division of Surveillance, Research and
    Communication Support
  • Toni Piazza-Hepp, PharmD, Acting Director
  • Division of Medication Errors and Technical
    Support
  • Carol Holquist, Director
  • Denise Toyer, PharmD, Deputy Director

4
Reorganization Goals
  • Reflect the commitment of CDER to sustained,
    multi-disciplinary, cross-Center approach to drug
    safety
  • Placement in organization must reflect level of
    commitment
  • Need focus and consistency and improvement in
    communication about drug risks and benefits
  • Need focus for cross-center policy development
  • Locus for Critical Path Activities

5
Reorganization Proposal
  • New Associate Center Director drug safety
    policy and risk communication focus
  • Consolidate certain communications activities
  • Elevated organizational status unit responsible
    for epidemiology and surveillance (current Office
    of Drug Safety)
  • Report to Center Director
  • New super-office combining OCPB, OB,
    responsible for CP projects and other
    cross-cutting science activities

6
New Database Acquisitions
  • Four organizations with linked pharmacy-medical
    claims databases
  • Contracts signed September 2005
  • Allows for collaborations between ODS
    epidemiologists and experts at these
    organizations
  • Four organizations
  • HMO Research Network/Harvard Pilgrim Health
  • Kaiser Family Foundation
  • Vanderbilt University
  • Ingenix (i3Drug Safety)

7
New Database Acquisitions
  • Four organizations
  • Harvard Pilgrim Health/HMO Research Network
  • Eight geographically diverse health plans with
    3.2 million members
  • Electronic medical records available for 6 of 8
    sites
  • Kaiser Family Foundation
  • 6.1 current members in northern and southern
    California
  • Fully integrated databases, linked to vital
    statistics and cancer registries
  • Unique formulary limited to selected drugs and
    indications
  • Vanderbilt University
  • Two state Medicaid populations (Tennessee and
    Washington)
  • 2.2 millions members, some at high medical risk
    (eg, the poor, nursing home residents)
  • Ingenix
  • Geographically diverse insured population of 12
    million members
  • Some laboratory data also available

8
CMS Interactions
  • ODS epidemiogists are working with CMS and AHRQ
    staff to understand better the nature of CMS data
  • Current efforts focused on using Part B data for
    a pilot drug safety study
  • Still in learning/exploratory stages

9
Active Surveillance
  • Request for Information issued April 2005
  • Responses received June 2005
  • Responses currently under review
  • Agency will decide on next steps

10
Other Developments
  • White Oak
  • ODS moved to White Oak in September 2005
  • All ODS offices on 3rd and 4th floors of the D
    wing
  • Allows for close collaboration within ODS and
    with the Office of New Drugs
  • Process Improvement Teams
  • Office of New Drugs Process Improvement Team
  • Office of Drug Safety Consult Improvement Team
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