View
218
Download
0
Tags:
Embed Size (px)
Citation preview
FDA Science Board Advisory FDA Science Board Advisory Committee MeetingCommittee Meeting
ORA Science Peer Review-ORA Science Peer Review-Pesticide and Industrial Chemical Pesticide and Industrial Chemical
ProgramsPrograms
April 22, 2004April 22, 2004
Overview of ORA Science Peer Overview of ORA Science Peer ReviewReview
John R. MarzilliJohn R. Marzilli
Deputy Associate Commissioner for Deputy Associate Commissioner for Regulatory AffairsRegulatory Affairs
John J. Specchio, Ph.D.John J. Specchio, Ph.D.
Professor of Food ScienceProfessor of Food Science
Montclair State UniversityMontclair State University
ORA Science Peer ReviewORA Science Peer Review
Objectives:Objectives:
– Quality of Science across our organizationQuality of Science across our organization: : Program Planning, Inspections, Investigations, Lab Program Planning, Inspections, Investigations, Lab Analysis, Regulatory Actions, Quality Management Analysis, Regulatory Actions, Quality Management SystemsSystems
– Adequacy of resourcesAdequacy of resources: Skills and Expertise, : Skills and Expertise, Technologies, Organizational InfrastructureTechnologies, Organizational Infrastructure
– Mission RelevanceMission Relevance
FDA’s MissionFDA’s Mission
The FDA is responsible for protecting the public The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security health by assuring the safety, efficacy, and security of human & veterinary drugs, biological products, of human & veterinary drugs, biological products, medical devices, our nations food supply, cosmetics medical devices, our nations food supply, cosmetics and products that emit radiation. The FDA is also and products that emit radiation. The FDA is also responsible for advancing the public health by responsible for advancing the public health by helping to speed innovations that make medicines helping to speed innovations that make medicines and foods more effective, safer, and more and foods more effective, safer, and more affordable; and by helping the public get the affordable; and by helping the public get the accurate science-based information they need to accurate science-based information they need to use medicines and foods to improve their health.use medicines and foods to improve their health.
ORA Science Peer ReviewORA Science Peer Review
Goal of Peer ReviewGoal of Peer Review
– Establish a roadmap for future improvement and Establish a roadmap for future improvement and coordination of ORA Pesticide and Industrial coordination of ORA Pesticide and Industrial Chemical ProgramsChemical Programs
– Establish a model for future review of additional Establish a model for future review of additional programsprograms
Team MembersTeam Members
John Marzilli, Deputy ACRAJohn Marzilli, Deputy ACRASusan Setterberg, Regional Director, Central Region Susan Setterberg, Regional Director, Central Region Co-Chair, Pat Schafer, Compliance Director, New Orleans Co-Chair, Pat Schafer, Compliance Director, New Orleans District District Tom Gardine, Philadelphia District DirectorTom Gardine, Philadelphia District DirectorSandra Whetstone, Director, Division of Compliance Sandra Whetstone, Director, Division of Compliance Management and Operations, Office of EnforcementManagement and Operations, Office of EnforcementMichael Ellison, National Food Expert, Division of Field Michael Ellison, National Food Expert, Division of Field InvestigationsInvestigationsFrank Mazzoni, Supervisor, Import Program, New England Frank Mazzoni, Supervisor, Import Program, New England District District Barbara George, Program Support Specialist, New Orleans Barbara George, Program Support Specialist, New Orleans DistrictDistrict
Team MembersTeam Members
Co-Chair, John Specchio, Ph.D., Science Advisor, Division Field Co-Chair, John Specchio, Ph.D., Science Advisor, Division Field Science (DFS)Science (DFS)Tom Savage, Deputy Director, DFSTom Savage, Deputy Director, DFSLarry D’Hoostelaere, Ph.D., Senior Scientific Coordinator, DFSLarry D’Hoostelaere, Ph.D., Senior Scientific Coordinator, DFSCharles Parfitt, Senior Scientific Coordinator, DFS Charles Parfitt, Senior Scientific Coordinator, DFS Tom Sidebottom, Assistant to Regional Director, Pacific RegionTom Sidebottom, Assistant to Regional Director, Pacific RegionMeredith Grahn, Assistant to the Regional Director, Southwest Meredith Grahn, Assistant to the Regional Director, Southwest RegionRegionRichard Baldwin, Senior Science Advisor, ORARichard Baldwin, Senior Science Advisor, ORA
OFFICE OF REGULATORY AFFAIRS190 OFFICES IN FY 2004
NORTHEASTPACIFIC CENTRAL
SOUTHEAST
SOUTHWEST03-04
Division of Planning, Evaluation, & MgmtORA Offices.ppt
REGIONAL OFFICES - 5DISTRICT OFFICES - 20RESIDENT INSPECTION POSTS - 140OCI FIELD OFFICES - 6OCI RESIDENT OFFICES - 6OCI DOMICILES - 13
CA
NV
WA
MT
ORID
AK
HI
AZ
UT
WY
CO
NM
TX
OK AR
MO
IANE
KS
TN NC
GAALMS
LA
FL
SC
PR
MEVT
NY
NH
MA
CTRI
MN
WI
IL
MI
INOH
PA
WV
KYVA
NJ
ND
SD
MDDE
VI
OFFICE OF REGULATORY AFFAIRS13 FIELD LABORATORIES
CURRENT FY 2004NORTHEAST
PACIFIC CENTRAL
SOUTHEASTSOUTHWEST
10/02
Division of Planning, Evaluation & MgmtORALABSCurr.PPT
5 MULTI-PURPOSE LABS 8 SPECIALTY LABS
SEATTLE
SAN FRANCISCO
LOS ANGELES
`
DENVERKANSAS CITY
JEFFERSON
DETROIT
FORENSICCHEMISTRY
CENTER
PHILADELPHIA
NEW YORK
WINCHESTER
ATLANTA
SAN JUAN
Overview of ORA Overview of ORA Science Peer ReviewScience Peer Review
John J. Specchio, Ph.DJohn J. Specchio, Ph.DORA Science AdvisorORA Science AdvisorProfessor of Food ServicesProfessor of Food ServicesMontclair State UniversityMontclair State UniversityMontclair, New JerseyMontclair, New Jersey
Peer Review ProcessPeer Review Process
Components: Components: – Design and Implementation of Data Review Design and Implementation of Data Review
ProcessProcess– Comprehensive Work Product Review on Comprehensive Work Product Review on
Pesticide & Industrial Chemical data Pesticide & Industrial Chemical data collected for one entire fiscal yearcollected for one entire fiscal year
– Structured discussions with Managers and Structured discussions with Managers and Technical expertsTechnical experts
Complexity of Review ModelComplexity of Review Model
8 District Offices visited8 District Offices visited
6 ORA Laboratories visited6 ORA Laboratories visited
12 additional District offices were 12 additional District offices were included in studyincluded in study
On-site visits included review On-site visits included review of: of:
Local SOPs for Domestic and Import WorkLocal SOPs for Domestic and Import Work
Sample Collection ReportsSample Collection Reports
Lab WorksheetsLab Worksheets
Establishment Inspection ReportsEstablishment Inspection Reports
Compliance ActionsCompliance Actions
Data Systems: FACTS, OASISData Systems: FACTS, OASISAll current guidanceAll current guidanceHistorical documents and earlier studiesHistorical documents and earlier studiesManagers and Technical Experts responsesManagers and Technical Experts responses
Database Research ModelDatabase Research Model
Used to validate the on-site interviewsUsed to validate the on-site interviewsReviewed 357 work productsReviewed 357 work productsFocused on all violative work products, Focused on all violative work products, and reviewed a portion of non-violativeand reviewed a portion of non-violativeOver 150 individuals interviewedOver 150 individuals interviewedAdditional comments received from all Additional comments received from all interested individualsinterested individualsAfter consolidation, nearly 100 pages of After consolidation, nearly 100 pages of comments were reviewed by the comments were reviewed by the committeecommittee
Analysis of Data Analysis of Data
5 Key Areas Emerged5 Key Areas Emerged– Program ManagementProgram Management– Laboratory Science IssuesLaboratory Science Issues– Productivity and TimelinessProductivity and Timeliness– ResourcesResources– Compliance and Regulatory PolicyCompliance and Regulatory Policy
Next StepsNext Steps
Finalize Review Finalize Review
Design a timeline for execution of proposed Design a timeline for execution of proposed improvementsimprovements
Final Report in Summer 2004Final Report in Summer 2004
Presentation to Science Board, Fall 2004Presentation to Science Board, Fall 2004
Thank YouThank You
John R. MarzilliJohn R. Marzilli
Deputy Associate Commissioner for Deputy Associate Commissioner for Regulatory AffairsRegulatory Affairs
John J. Specchio, Ph.D.John J. Specchio, Ph.D.
Professor of Food ScienceProfessor of Food Science
Montclair State UniversityMontclair State University