Ellen F. MorrisonAssistant Commissioner for Operations

Office of Regulatory AffairsFDA

FDA –

Progress, Trends and Compliance

AFDO 118th Annual Educational ConferenceDenver, 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

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FDA Foreign Offices and Posts

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FDA – Progress, Trends and Compliance

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FDA - Progress, Trends and Compliance

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.

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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.

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FDA – Progress, Trends and Compliance

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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

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

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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.

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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

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Inspections Data FY 2004 – FY 2013Inspections Data FY 2004 - FY 2013  

Inspections - FDA Domestic (Excludes State Contract and State Partnership Inspections  

Fiscal Year Total Inspections *Unique Count Foods Cosmetics Biologics Human Drugs Animal Drugs & Feeds Medical Devices and Rad. Health Tobacco ProductsFY 2004 20,815   11,004 118 2,009 2,232 2,915 2,537  FY 2005 18,885   8,770 138 1,893 2,315 3,430 2,339  FY 2006 16,766   7,500 151 1,806 2,065 2,893 2,351  FY 2007 14,555   6,489 114 1,840 1,829 2,173 2,110  FY 2008 14,222 13,728 6,544 92 1,673 1,777 2,136 2,000  FY 2009 14,985 14,465 7,176 98 1,729 1,876 1,951 2,155  FY 2010 17,676 16,976 8,781 132 1,904 2,142 2,181 2,536 1 FY 2011 19,477 18,634 10,517 153 2,012 2,215 2,051 2,529  FY 2012 19,230 18,230 10,086 160 1,972 2,120 2,108 2,741 43 FY 2013 16,699 15,792 7,658 125 2,004 1,851 2,131 2,887 43

 

Inspections - FDA Foreign  

Fiscal Year Total Inspections *Unique Count Foods Cosmetics Biologics Human Drugs Animal Drugs & Feeds Medical Devices and Rad. Health Tobacco Products

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 10 50 813 85 453  

FY 2013 2,915 2,840 1,403 5 74 827 71 535   

Inspections - State Domestic (Includes State Contract and State Partnership Inspections)  

Fiscal Year Total Inspections *Unique CountFoods & Cosmetics Cosmetics Biologics Human Drugs Animal Drugs & Feeds Medical Devices and Rad. Health Tobacco Products

FY 2004 22,053   8,762     146 4,623 8,522  FY 2005 22,439   9,420     150 4,480 8,389  FY 2006 24,061   8,959     126 6,740 8,236  FY 2007 25,324   9,841     167 6,939 8,377  FY 2008 25,358 25,361 10,330     186 6,499 8,343  FY 2009 25,987 26,113 10,954     186 6,528 8,319  FY 2010 24,701 24,955 10,105     173 6,200 8,223  FY 2011 24,061 24,949 9,983     150 5,776 8,152  FY 2012 22,988 23,799 9,804     100 5,126 7,958  FY 2013 22,492 22,492 9,557     30 5,094 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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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

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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

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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

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FDA – Progress, Trends and Compliance

ORADSS Imports and PREDICT UniverseIdentification of additional data elements and cleanup of canned reports to better address the needs of users

Firm management harmonization with DUNSCoordination 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)

Import IT Projects (cont.)

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Trends in Imported Products

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• 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

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• 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

18M 21M 23M 28M 29M

10% CAGR

Increasing import workload creates a need for process improvements

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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

PREDICT supports efficient use of data to assess risk for each import line

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FDA – Progress, Trends and Compliance

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

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Snapshot of FDA’s Analytical Work

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Total number of samples analyzed by FDA/ORA labs in the various testing program areas

FDA’s Network of Collaboration

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Number of samples analyzed by FERN laboratories for FDA:

Year Assignment/Activation DisciplineTotal samples

analyzed by FERN labs

Total samples analyzed by Cooperative Agreement Labs

2007 Melamine in Pet Food Chemistry 200

2008 Salmonella St Paul Pepper Activation Microbiology 2902008 Melamine in Infant Formula Chemistry 340

2008

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

Conventions Micro/Rad/Chem 3642009 Inauguration Assignment Micro 11

Chem 182010 Deepwater Horizon Oil Spill Assignment Chem 3072011 Produce Assignment Microbiology 939

2011-2012 CVM Special Project-Pet food testing Microbiology 574

2012Polictical Convention Surveillance

Assignment Microbiology 153Chemistry 186

Radiological 1432012 Arsenic Assignment in Rice and Juice Chemistry Rice = 170

Juice = 932014 High Volume Surveillance - Avocados Microbiology 143 and counting

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

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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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