Upload
elvin-newton
View
232
Download
0
Tags:
Embed Size (px)
Citation preview
Enforcement Litigation and Compliance
Washington, DC
December 9-10, 2015
ORA and FDA District Directors Forum
Randy Pack, Director, Compliance Branch, Baltimore District, FDA
Douglas Stearn, Director, Office of Enforcement and Import Operations,
Moderated by Steven Niedelman, Lead Quality Systems and Compliance Consultant, King & Spalding LLP
Transforming FDA’s Office of Regulatory Transforming FDA’s Office of Regulatory Affairs’ Operations and OrganizationAffairs’ Operations and Organization
Douglas StearnDouglas StearnDirector, Office of Enforcement & Import OperationsDirector, Office of Enforcement & Import Operations
U.S. Food and Drug AdministrationU.S. Food and Drug Administration
Enforcement, Litigation, and Compliance ConferenceEnforcement, Litigation, and Compliance ConferenceFood and Drug Law InstituteFood and Drug Law Institute
December 10, 2015December 10, 2015
FDA/ORA’s Drivers of Change FDA/ORA’s Drivers of Change
Program Alignment Implementing Legislation and Center
Initiatives ORA’s Strategic Priorities
Program Alignment - CommitmentsProgram Alignment - Commitments
1. Establish Commodity-Based and Vertically Integrated Regulatory Programs
2. Increase Specialization
3. Enhance Training
4. Revamp Agency Work Planning
5. Improve Compliance Policy and Enforcement Strategies
6. Enhance Import Operations
7. Advance Lab Optimization
8. Address Delayering/Streamlining
ORA Organizational Chart - CurrentORA Organizational Chart - Current
ORA Operations - Current StructureORA Operations - Current Structure
ORA Operations - Future StructureORA Operations - Future Structure
What does this mean for me?What does this mean for me?
Inspectorate specialized by program Expanded technical expertise Increased ability to keep pace with changes in
manufacturing Goal of reduced timeframes for decision-making
through both streamlining as well as team-based approaches
Some Hot Issues in Field OperationsSome Hot Issues in Field Operations
FSMA rules implementation : accredited third party certification, produce rule, foreign supplier verification programs, preventative controls rule, sanitary transportation rule, intentional adulteration rule
FDASIA implementation GDUFA: ramping up drug inspections worldwide Administrative destruction
Increased surveillance and actions Compounding Dietary Supplements Data Integrity
FDA District Office Operation
Randy Pack, Director, Compliance Branch
Baltimore DistrictFood and Drug Administration
Enforcement, Litigation, and Compliance Conference
Food and Drug Law InstituteDecember 10, 2015
11
12
District Setup
13
14
Investigations Branch Consists of the following:
•Branch Director (DIB)•Deputy Director (DDIB)•Supervisory Consumer Safety Officers (SCSOs) District Office & Resident Posts (RPs)•Consumer Safety Officers (CSOs) “Investigators” •Consumer Complaint Coordinator•Consumer Safety Technicians (CST)•Program Support Specialists (PSS)•Official Establishment Inventory (OEI) Coordinator
15
Programs covered by Investigations Branch
(foreign/domestic)
• Food Safety• Fish and Fishery Products• Medical Devices• Drugs (GMP, Pre-approval) • Biologics (Blood Banks, Plasma and Human
Tissue)• Interstate Travel Program• Veterinary Medicine• BSE/Ruminant Feed Ban/Medicated Feed • Bioresearch Monitoring Program (BIMO)• Mammography/X-Ray• Imports• Tobacco
16
IB Operations
•ORA Workplan•ORA Performance Goals•Assignments from the Centers, i.e.•Consumer Complaints•Recall Effectiveness•Referrals from State, OCI
17
FDA Field Investigators (CSOs)– Conduct Establishment Inspections (Domestic & Foreign)– Perform Investigations
• Consumer Complaint follow-ups• Injury and Adverse Reactions• Foodborne Outbreaks• Tampering• Health Fraud
– Perform Recall Activities• Effectiveness checks• Attachment B Information
– Conduct Sample Collections (Domestic & Imports)– Perform Field Examinations– Entry Review/Imports Operations– Referrals from the States, OCI
Inspection Classification
• NAI - No Action Indicated• VAI – Voluntary Action Indicated (FDA 483
Issued)• OAI – Official Action Indicated (FDA 483
Issued)– Compliance Branch Involvement– Determination of Compliance Action
•Administrative Action•Enforcement Action
18
FDA 483
19
Questions about Inspection or Investigator
• Supervisory Consumer Safety Officer (SCSO)
• Director of Investigations• Director of Compliance• District Director
20
21
Compliance Branch Consists of the following:
•Branch Director (DCB)•Compliance Officers (COs)
– Domestic– Import
•Recall Coordinator•Freedom of Information Specialist•Safety Technicians (CST)
Administrative Actions• Civil Money Penalty (Medical
Devices)• Untitled Letter• Mandatory Recall (Food & Feed,
Medical Devices)• Registration Suspension (Food &
Feed)• Regulatory Meeting• Warning Letter• Combination of Actions• Other Actions based on Program
Area22
Enforcement Actions
• Civil • Seizures• Injunctions
• Criminal (Office Criminal Investigations)
23
Compliance Determination• Firm History
– Inspectional– Compliance
• Product Type• Did you report? MDR, Recalls• Who’s Responsible• Risk to Public• Firm’s Corrective Actions *No Perfect Firm*• Center & HQ Discussion
24