1. 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

2. Transforming FDA’s Office of Regulatory Affairs’ Operations and Organization Douglas Stearn Director, Office of Enforcement & Import Operations U.S. Food and Drug Administration Enforcement, Litigation, and Compliance Conference Food and Drug Law Institute December 10, 2015

3. FDA/ORA’s Drivers of Change  Program Alignment  Implementing Legislation and Center Initiatives  ORA’s Strategic Priorities

4. Program 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

6. ORA Organizational Chart - Current ACRA Deputy ACRA & Partnerships & Policy IT Staff Communication, Quality Systems Management & Project Management Executive Secretariat Office of Partnerships Office of Policy Assistant Commissioner for Operations Human & Animal Food Operations Office of Enforcement & Import Operations Medical Products & Tobacco Operations Office of Regulatory Science Audit Staff Northeast Region Central Region Southeast Region Southwest Region Pacific Region Office of Criminal Investigations Office of Resource Management

7. ORA Operations - Current Structure Operations Central Region Baltimore District Cincinnati District Chicago District Detroit District Minneapolis District New Jersey District Philadelphia District Detroit Laboratory Forensic Chemistry Center Philadelphia Laboratory Northeast Region New England District New York District Northeast Regional Laboratory Winchester Engineering Analytical Center Southeast Region Atlanta District Florida District New Orleans District San Juan District San Juan Laboratory Southeast Regional Laboratory Southwest Region Dallas District Denver District Kansas District Southwest Imports District Arkansas Regional Laboratory Denver Laboratory Kansas Laboratory Pacific Region Los Angeles District San Francisco District Seattle District Pacific Regional Laboratory Northwest Pacific Regional Laboratory Southwest San Francisco Laboratory Human & Animal Food Operations Medical Products & Tobacco Operations Enforcement & Import Operations Regulatory Science Audit Staff

8. ORA Operations - Future Structure Operations Pharmaceutical Quality Operations Director, Alonza Cruse Four Management Teams Biologics Operations Director, Anne Reid Acting Two Management Teams Medical Devices Operations Director, Jan Welch Three Management Teams BIMO Operations Two Management Teams Tobacco Operations Human and Animal Food Operations Director, Joann Givens 12 Management Teams Audit Staff

9. 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

10. Some 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

11. FDA District Office Operation Randy Pack, Director, Compliance Branch Baltimore District Food and Drug Administration Enforcement, Litigation, and Compliance Conference Food and Drug Law Institute December 10, 2015 11

12. 12

13. District Setup District Director Investigations Branch Compliance Branch *Imports Branch Administrative Branch 13

14. 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. 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. 16 IB Operations ORA Workplan ORA Performance Goals Assignments from the Centers, i.e. Consumer Complaints Recall Effectiveness Referrals from State, OCI

17. 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

18. 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

19. FDA 483 19

20. Questions about Inspection or Investigator Supervisory Consumer Safety Officer (SCSO) Director of Investigations Director of Compliance District Director 20

21. 21 Compliance Branch Consists of the following: Branch Director (DCB) Compliance Officers (COs) –Domestic –Import Recall Coordinator Freedom of Information Specialist Safety Technicians (CST)

22. 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 Area 22

23. Enforcement Actions Civil Seizures Injunctions Criminal (Office Criminal Investigations) 23

24. 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

25. Questions?? randy.pack@fda.hhs.gov 25