Ellen F. Morrison Assistant Commissioner for Operations Office of Regulatory Affairs FDA

1. Ellen F. MorrisonAssistant Commissioner for OperationsOffice of Regulatory AffairsFDA FDA – Progress, Trends and Compliance AFDO 118th Annual Educational Conference Denver, Colorado June 24, 2014

2. FDA - Progress, Trends and Compliance New Laws • Food Safety Modernization Act (FSMA) • Food and Drug Administration Safety and Innovation Act (FDASIA) • Drug Quality and Security Act (DQSA) • Tobacco Control Act (CTP) • Established 5 person dedicated cadre AFDO, June 24, 2014

3. FDA – Progress, Trends and Compliance Globalization • The rise of global markets and supply chains • Growing complexity of medical products and product development • Rapid advances in science and technology • Rise in the number of imported products • Risk-based focus for regulated products • Transformation from a domestic focused Agency to a global agency • FDA continues to increase the number of foreign inspections • FDA has global offices AFDO, June 24, 2014

4. FDA Foreign Offices and Posts FDA – Progress, Trends and Compliance AFDO, June 24, 2014

5. FDA - Progress, Trends and Compliance AFDO, June 24, 2014

6. FDA – Progress, Trends and Compliance The Food Safety and Modernization Act (FSMA) • A new public health mandate • Global scale and complexity of the food system • Increasingly diverse and complicated processes • Complex and extended supply chains • Integrated and collaborative approach within FDA • Leveraging and collaboration in partnership with federal, state, local, tribal, territorial, and foreign agencies AFDO, June 24, 2014

7. FDA – Progress, Trends and Compliance FSMA (cont.) • ORA co-leads several FSMA workgroups with CFSAN and CVM, to develop the operational framework for implementing FSMA. • The FSMA Operations Team (or FOT) is composed of cross-operational workgroups (Import Controls Team, Produce Safety Team, and Preventive Controls Team). • Overseeing the work produced by the FOT workgroups are the FSMA Steering Committee, Executive Council, and then finally an OFVM Governance Board. • Workgroup membership is largely subject matter experts from ORA, CFSAN, CVM, and state representatives. AFDO, June 24, 2014

8. FDA – Progress, Trends and Compliance FSMA (cont.) • The FOT workgroups are charged with such activities as determining FDA and state investigator training, industry education and outreach, and building more robust IT systems for enhanced data integration and analysis and information sharing. • There will likely be a huge culture shift for ORA investigators who have been traditionally trained to collect evidence of non-compliance. • There will be new modernized approaches to inspections and enforcement based on more of a prevention framework. The focus will be voluntary compliance before use of traditional and new enforcement tools (administrative detention, registration suspension, and mandatory recall). • More collaboration with CFSAN, CVM, and our state partners on efforts including risk-based workplanning, field assignments, resources allocation, and performance metrics. AFDO, June 24, 2014

9. FDA – Progress, Trends and Compliance The Food and Drug Administration Safety and Innovation Act (FDASIA) • Promoting innovation and enhancing the safety of the drug supply chain • Pharmaceutical quality systems and cGMPs • Development of new inspection protocols and data sharing systems AFDO, June 24, 2014

10. FDA – Progress, Trends and Compliance Drug Quality and Security Act (DQSA) • Designed to improve the safety of drug compounding and further protect the drug supply by building an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. • Signed November 27, 2013 AFDO, June 24, 2014

11. FDA – Progress, Trends and Compliance DQSA (cont.) • Compounding new provision for “outsourcer” establishments 503B • Outsourcer is – one geographic location engaged in compounding of sterile drugs • Must comply with cGMPs • Inspected according to risk based schedule • Requirements – such as reporting adverse events, provide information on products they compound • To date – we have 48 Registered Outsourcers • Continue to inspect both 503A & 503B compounding facilities • To date in FY14 we have inspected 35 facilities AFDO, June 24, 2014

12. FDA – Progress, Trends and Compliance Collaboration with States • New Long-Term Food Information Sharing Agreement (ISA) – a single-signature Food and Feed 20.88 agreement • Funding of integration efforts • Progress of Rapid Response Teams • FSMA Section 210 – Grants to enhance food safety; cooperative agreements to support states in developing advanced capabilities in investigations, inspections, response, laboratories. AFDO, June 24, 2014

13. FDA – Progress, Trends and Compliance Collaboration with States (cont.) • Investment in Partnerships for Food Protection • Investment in Partnerships with Associations • AFDO • NASDA • APHL • NEHA • NACCHO • AAFCO AFDO, June 24, 2014

14. Inspections Data FY 2004 – FY 2013 AFDO, June 24, 2014

15. Interagency Workgroups Border Interagency Executive Council (BIEC) The BIEC is designed to provide a forum for interagency coordination on matters relating to import safety with representatives from 10 federal agencies. Industry Working Group (IWG) The IWG develops recommendations to enhance the effectiveness of the FDA and improve the import clearance process at the same time. The group included over 50 members from a broad array of import community members. Automated Customs Environment (ACE)/ International Trade Data System (ITDS) FDA works with CBP and other government agencies in preparation of the ACE and the ITDS. As the largest participating government agency, FDA is committed to be fully ready for the ACE/ITDS deployment. FDA – Progress, Trends and Compliance AFDO, June 24, 2014

16. Interagency Workgroups Trusted Trader Program Working Group (TTP) The TTP is composed of industry and government representatives and is tasked with defining and finalizing Trusted Trader Programs; providing standards for participation and defining benefits to the trade participants. Commercial Targeting and Analysis Center (CTAC) CTAC provides a streamlined communication channel between agencies, enhancing Federal efforts to address import safety issues. Representatives from partner agencies are co-located in order to share knowledge, experience, and best practices for effective enforcement of our Nation’s laws. FDA – Progress, Trends and Compliance AFDO, June 24, 2014

17. Import IT Projects PREDICT Threshold Analysis Develop commodity specific scoring and thresholds to improve Center rule alteration and increase system May Proceed rate Medical Device Filer Outreach Report Improve industry guidance through sharing of line level medical device data issues to reduce admissibility review time and increase system May Proceed rate ITACS Account Management Support enhanced communication with filers through implementation of a secure account system Interoperability Web Services (IWS) Development Programming of the IWS communication linkage between CBP and FDA under the ACE initiative FDA – Progress, Trends and Compliance AFDO, June 24, 2014

18. FDA – Progress, Trends and Compliance Import IT Projects (cont.) • ORADSS Imports and PREDICT Universe • Identification of additional data elements and cleanup of canned reports to better address the needs of users • Firm management harmonization with DUNS • Coordination with the Firm Management team and Dun & Bradstreet to harmonize our firm inventory with the DUNS Number to support a unique identifier for each firm in FDA’s inventory • Remote Training • Develop video modules for using various systems (ex. ER, OASIS, ITACS) AFDO, June 24, 2014

19. Trends in Imported Products FDA – Progress, Trends and Compliance • More foreign facilities supplying the U.S. • Increasing volume of imported products • More outsourcing of manufacturing • More complexity in manufacture & supply • Imports involving countries with less developed regulatory systems AFDO, June 24, 2014

20. High Profile Incidents FDA – Progress, Trends and Compliance • Heparin contamination • Series of DEG poisonings • Salmonella Saintpaul (peppers) • Salmonella Typhimurium (peanuts) • Melamine contamination in pet food • Melamine contamination in dairy products • Infant formula without nutrients • Counterfeits AFDO, June 24, 2014

21. FDA – Progress, Trends and Compliance Increasing import workload creates a need for process improvements 10% CAGR 18M 21M 23M 28M 29M AFDO, June 24, 2014

22. PREDICT supports efficient use of data to assess risk for each import line FDA – Progress, Trends and Compliance • Results of field exams and sample analyses of previous lines • Results of facility inspections • Ratings of inherent product risks • Accuracy of product, facility, and affirmation of compliance data

23. FDA – Progress, Trends and Compliance Laboratory Optimization • Evaluation of work planning related to ORA laboratories for food and feed programs and medical product and tobacco programs. • Intended to achieve the most effective program allocation based on each laboratory’s resources including numbers of employees, personnel proficiency, instrumentation, technology platforms and facilities AFDO, June 24, 2014

24. Snapshot of FDA’s Analytical Work Total number of samples analyzed by FDA/ORA labs in the various testing program areas AFDO, June 24, 2014

25. FDA’s Network of Collaboration Number of samples analyzed by FERN laboratories for FDA: AFDO, June 24, 2014

26. FDA – Progress, Trends and Compliance Program Alignment • Commissioner Hamburg announced the Program Alignment initiative in September, 2013 • Increase operational and program alignment as FDA transitions to distinct commodity-based and vertically integrated regulatory programs • Pharmaceutical Quality • Food and Feed • Medical Devices and Radiological Health • Tobacco • Bioresearch Monitoring AFDO, June 24, 2014

27. FDA – Progress, Trends and Compliance Program Alignment (cont.) • ORA and the Centers will collaborate more closely • Enhance specialization by program • Work is based on risk to maximize our public health impact • ORA’s basic responsibilities and functions will remain the same – our tools in our tool kit will change • Streamline our business processes and decision making • Increase efficiency across each program • Enhance our public health protection AFDO, June 24, 2014