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
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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)
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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
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
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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 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
10
5
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.
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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
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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
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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
• 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
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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
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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
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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
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FDA – Progress, Trends and Compliance
Program Alignment (cont.)
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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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