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Ellen F. Morrison Assistant Commissioner for Operations Office of Regulatory Affairs FDA. FDA – Progress, Trends and Compliance. AFDO 118 th Annual Educational Conference Denver, Colorado June 24, 2014. FDA - Progress, Trends and Compliance. New Laws Food Safety Modernization Act (FSMA) - PowerPoint PPT Presentation
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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
19
• 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
20
• 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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