FDA – Progress, Trends, and Compliance

FDA – Progress, Trends and Compliance Ellen F. Morrison Assistant Commissioner for Operations Office of Regulatory Affairs FDA AFDO 118th Annual Educational Conference Denver, Colorado June 24, 2014

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

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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

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FDA – Progress, Trends and Compliance

FDA Foreign Offices and Posts

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FDA - Progress, Trends and Compliance

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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

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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

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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

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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

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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

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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

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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

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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

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Inspections Data FY 2004 – FY 2013 Inspections Data FY 2004 - FY 2013 Inspections - FDA Domestic (Excludes State Contract and State Partnership Inspections Fiscal Year FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2013

Total Inspections 20,815 18,885 16,766 14,555 14,222 14,985 17,676 19,477 19,230 16,699

*Unique Count

13,728 14,465 16,976 18,634 18,230 15,792

Foods 11,004 8,770 7,500 6,489 6,544 7,176 8,781 10,517 10,086 7,658

Cosmetics 118 138 151 114 92 98 132 153 160 125

Biologics 2,009 1,893 1,806 1,840 1,673 1,729 1,904 2,012 1,972 2,004

Human Drugs 2,232 2,315 2,065 1,829 1,777 1,876 2,142 2,215 2,120 1,851

Animal Drugs & Feeds 2,915 3,430 2,893 2,173 2,136 1,951 2,181 2,051 2,108 2,131

Medical Devices and Rad. Health 2,537 2,339 2,351 2,110 2,000 2,155 2,536 2,529 2,741 2,887

Tobacco Products

Animal Drugs & Feeds

Medical Devices and Rad. Health

Tobacco Products

1 43 43

Inspections - FDA Foreign Fiscal Year

Total Inspections

*Unique Count

Foods

Cosmetics

Biologics

Human Drugs

FY 2004

929

153

17

374

39

346

FY 2005

845

132

40

370

33

270

FY 2006

795

125

22

342

34

272

FY 2007

1,010

97

41

502

41

329

FY 2008

961

946

153

52

461

33

262

FY 2009

1,254

1,221

217

68

636

54

279

FY 2010

1,459

1,426

354

59

664

57

325

FY 2011

2,247

2,228

1,001

58

727

53

408

FY 2012

2,758

2,712

1,347

50

813

85

453

FY 2013

2,915

2,840

1,403

74

827

71

535

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Inspections - State Domestic (Includes State Contract and State Partnership Inspections) Fiscal Year FY 2004 FY 2005 FY 2006 FY 2007 FY 2008 FY 2009 FY 2010 FY 2011 FY 2012 FY 2013

Total Inspections 22,053 22,439 24,061 25,324 25,358 25,987 24,701 24,061 22,988 22,492

*Unique Count

25,361 26,113 24,955 24,949 23,799 22,492

Foods & Cosmetics 8,762 9,420 8,959 9,841 10,330 10,954 10,105 9,983 9,804 9,557

Cosmetics

Biologics

Human Drugs 146 150 126 167 186 186 173 150 100 30

Animal Drugs & Feeds 4,623 4,480 6,740 6,939 6,499 6,528 6,200 5,776 5,126 5,094

Medical Devices and Rad. Health 8,522 8,389 8,236 8,377 8,343 8,319 8,223 8,152 7,958 7,811

*Note (1): Total (Sum) may be greater than or equal to the sum of the respective program areas since some inspections may cover more than one program area. *Note (2): Unique Count may be less than or equal to the sum of the respective program areas since some inspections may cover more than one program area. *Note (3): Data extracted from FACTS on 12/11/13 ** The count of inspections for any program area sub-total may or may not be equal to the sum of the respective sub-categories since an inspection may cover components in more than one program area; ** All Data from OPRM/DPEM Tables Generated 12/2013

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Tobacco Products

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FDA – Progress, Trends and Compliance

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. AFDO, June 24, 2014

FDA – Progress, Trends and Compliance

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.

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FDA – Progress, Trends and Compliance

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 AFDO, June 24, 2014

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)

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FDA – Progress, Trends and Compliance

Trends in Imported Products • • • • •

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

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FDA – Progress, Trends and Compliance

High Profile Incidents • 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

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FDA – Progress, Trends and Compliance

Increasing import workload creates a need for process improvements

10%

CAGR

18M

21M

23M

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28M

29M

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FDA – Progress, Trends and Compliance

PREDICT supports efficient use of data to assess risk for each import line • 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 AFDO, June 24, 2014

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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

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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

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FDA’s Network of Collaboration Number of samples analyzed by FERN laboratories for FDA: Total samples analyzed Total samples by Cooperative analyzed by FERN labs Agreement Labs

Year

Assignment/Activation

Discipline

2007

Melamine in Pet Food

Chemistry

2008 2008

Salmonella St Paul Pepper Activation Melamine in Infant Formula

Microbiology Chemistry

290

2008 2009

Special Event Food Defense Assignment (SEFDA) / 2008 National Political Conventions Inauguration Assignment

364 11 18

2010 2011 2011-2012

Deepwater Horizon Oil Spill Assignment Produce Assignment CVM Special Project-Pet food testing

Micro/Rad/Chem Micro Chem Chem Microbiology Microbiology

2012

Polictical Convention Surveillance Assignment

2012

Arsenic Assignment in Rice and Juice

Microbiology Chemistry Radiological Chemistry

2014

High Volume Surveillance - Avocados

Microbiology

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200

340

307 939 574 153 186 143 Rice = 170 Juice = 93 143 and counting

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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

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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

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