1. 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

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
FDA Foreign Offices and Posts
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 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
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 Products
FY 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
Inspections - FDA Foreign
929 17
374 39
346
845 40
370 33
270
795 22
342 34
272
1,010 97 41
502
329
961
946 52
461
262
1,254
1,221
217 68
636 54
279
1,459
1,426
354 59
664 57
325
2,247
2,228
1,001 58
727 53
408
2,758
2,712
1,347 10 50
813 85
453
2,840
1,403 5 74
827 71
535
Inspections - State Domestic (Includes State Contract and State Partnership Inspections)
Foods & Cosmetics
22,053
8,762
146
4,623
8,522
22,439
9,420
150
4,480
8,389
24,061
8,959
126
6,740
8,236
25,324
9,841
167
6,939
8,377
25,358
25,361
10,330
186
6,499
8,343
25,987
26,113
10,954
6,528
8,319
24,701
24,955
10,105
173
6,200
8,223
24,949
9,983
5,776
8,152
22,988
23,799
9,804
100
5,126
7,958
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
AFDO, June 24, 2014

15. Interagency Workgroups
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

16. Interagency Workgroups
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.
AFDO, June 24, 2014

17. Import IT Projects FDA – Progress, Trends and Compliance
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

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
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
AFDO, June 24, 2014

20. High Profile Incidents
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
AFDO, June 24, 2014

21. Increasing import workload creates a need for process improvements
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. 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

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:
Year
Assignment/Activation
Discipline
Total 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
290
Melamine in Infant Formula
340
Special Event Food Defense Assignment (SEFDA) / 2008 National Political Conventions
Micro/Rad/Chem
364
2009
Inauguration Assignment
Micro 11
Chem 18
2010
Deepwater Horizon Oil Spill Assignment
307
2011
Produce Assignment
939
CVM Special Project-Pet food testing
574
2012
Polictical Convention Surveillance Assignment
153
186
Radiological
143
Arsenic Assignment in Rice and Juice
Rice = 170
Juice = 93
2014
High Volume Surveillance - Avocados
143 and counting
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