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

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District Setup

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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

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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

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IB Operations

•ORA Workplan•ORA Performance Goals•Assignments from the Centers, i.e.•Consumer Complaints•Recall Effectiveness•Referrals from State, OCI

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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

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FDA 483

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Questions about Inspection or Investigator

• Supervisory Consumer Safety Officer (SCSO)

• Director of Investigations• Director of Compliance• District Director

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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

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Enforcement Actions

• Civil • Seizures• Injunctions

• Criminal (Office Criminal Investigations)

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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

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Questions??

randy.pack@fda.hhs.gov

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