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Globalization and Its Impact on
ORA and Regulated Industry
Mutahar Shamsi
Acting Regional Food and Drug Director
Northeast Region, FDA
2013 RAPS: The Regulatory Convergence
Global FDA Compliance Update
October 1, 2013 December 9, 2013
Boston Waltham, Massachusetts
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FY 12 Import Data
Nationwide Total: 29,492,157 lines
• NER: 5,123,709 (about 17% of all US lines)
• NWE-DO: 558,077 (ranks 10th of all districts; about 2% of all US lines)
• NYK-DO: 4,565,632 (ranks 2nd of all districts; about 15% of all US lines)
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FY 13 Import Data
Nationwide Total: 32,646,214 lines
• NER: 5,333,087 (16% of all US lines)
• NWE-DO: 563,655 (ranks 11th of all districts; about 2% of all US lines)
• NYK-DO: 4,769,432 (ranks 2nd of all districts; about 15% of all US lines)
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Import Data
Regulated Area
• NWE-DO
• Human Foods: 55%
• Devices: 30%
• Animal Foods:4%
• Drugs: 1.5%
• NYK-DO
• Human Foods: 49%
• Cosmetics: 24%
• Devices: 11%
• Drugs: 2%
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Import Data
Product
• Devices
• NWE-DO
1. Laparoscope
2. patient physiological monitor
3. percutaneous catheter
• NYK-DO
1. unscented menstrual pads
2. sunglasses
3. corrective shoe orthosis
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Import Data
Product
• Drugs
• NWE-DO
1. relaxant, N.E.C.
2. pharmaceutical necessities & containers
3. pharmaceutical necessities, N.E.C.
• NYK-DO
1. ultraviolet screen, N.E.C.
2. triclosan (disinfectant)
3. oxybenzone (UV screen)
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Import Data
Product
• Biologics
• NWE-DO
1.biological in-vivo & in-vitro diagnostics, N.E.C.
2.in-vitro diag products, N.E.C.
3.human serum
• NYK-DO
1.biological in-vivo & in-vitro diagnostics, N.E.C.
2.in-vitro diag products, N.E.C.
3. peripheral blood stem cells
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Import Data
Import AlertsNWE-DO:
CDER products: 3
• unapproved new drug (IA 66-41)
CDRH products: 9
• gloves – holes/defects (IA 80-04)
• electrical muscle stimulators/iontophoresis devices
(IA 89-01)
• lacks 510(k) or PMA (IA 89-08)
• laser products not meeting performance standard
(IA 95-04)
CBER products: 0 (zero)
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Import Data
Import AlertsNYK-DO:
CDER products: 31
• unapproved new drug (IA 66-41)
• micro contamination of drugs (IA 55-05)
CDRH products: 6
• gloves – holes/defects (IA 80-04)
• lacks 510(k) or PMA (IA 89-08)
• surgical instruments from Pakistan (IA 76-01)
CBER products: 0 (zero)
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Import Data
Ports of Entry
• NWE-DO
• Logan Airport
• Houlton ME
• Conley Terminal
• NYK-DO
• Buffalo/Niagara Falls
• Newark NJ
• Champlain/Rouses PT.
Globalization - Trends
32 million shipments arrive at over 300 U.S. ports of entry annually
FDA-regulated products originate from more than 150 countries 130,000 importers
300,000 foreign facilities
Growth is expected to continue
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Globalization - Production
Food ~15% of all food consumed by U.S. households is imported
Approximately 50% of fresh fruits and 20% of fresh vegetables are imported
80% of seafood eaten domestically come from outside the United States
Food imports have increased an average of 10% per year from 2005-2011
Devices At least 35% of all medical devices used in the United States are
imported
Medical device imports have grown at over 10% per year from 2005-2011
Drugs 80% of API manufacturers are located outside the United States
40% of finished drugs are manufactured abroad
Pharmaceutical product imports increased at nearly 13% per year from 2005-2011 16
Globalization - Challenges
Increased number of “facilities” - individuals, producers, and companies - geographically dispersed worldwide importing regulated products into the U.S. at increasing volumes
Complex supply chains for given product; more complex manufacturing processes
Growing availability of distribution channels for products (e.g., Internet, couriers)
Facilitated by better product mobility as a result of improvements in transportation
Increased potential to encounter Intentional adulteration & counterfeiting for economic or other reasons 17
Moving FDA Towards a Global
Operations Paradigm http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Rep
orts/UCM298578.pdf
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“Over the next decade, FDA will continue to
transform from a predominantly domestically
focused Agency, operating in a globalized
economy, to an Agency fully prepared for a
regulatory environment in which FDA products
know no borders.”
-- FDA Global Engagement Report
April 2012
2020
Global Building Blocks• Enhanced import risk management/targeting tools
– PREDICT
• Increase in foreign inspections overseas & creation of dedicated
foreign inspection cadres
– Drug, Food, Devices
• Establishment of foreign offices
– Relationship building with CAs, information gathering/sharing,
technical assistance, assistance with in-country emergency
response, inspections
• Comparability/equivalence determinations
• International agreements & multilateral activities including
harmonization efforts
– Promotes information sharing, work sharing
– Codex, PIC/S, Medical Device Single Audit
• Capacity building through leveraging with donor organizations 2121
FDA Foreign Offices
HeadquartersSilver Spring, MD
Mexico City
San Jose
Santiago
Amman
London
Parma
Brussels
Pretoria
New Delhi
Mumbai
Beijing
Shanghai
Guangzhou
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Organizational Changes to Support
Shifts to Address Globalization
Office of the Commissioner Reorganization
Directorates
− Office of Operations
− Office of Foods
− Office of Medical Products and Tobacco
− Office of Global Regulatory Operations and Policy
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Office of Global Regulatory
Operations and Policy (GO)
Components of Office of Global Regulatory
Operations and Policy (GO) Office of Regulatory Affairs
Office of International Programs
GO Directorate Mandate Make FDA’s response to globalization challenges and import safety a top
priority in years to come
Ensure that FDA fully integrates its domestic and international programs to
best promote and protect public health
Implement “Pathway to Global Product Safety and Quality”
Ensures that FDA integrates its domestic and international programs
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http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsan
dPolicy/GlobalProductPathway/UCM262528.pdf29
Four Pillars to New Strategy
• Partner with foreign counterparts to create global coalitions of regulators focused on ensuring and improving global product safety.
• Work with these coalitions to build a global data-information system and network and proactively share data with peers.
• Expand capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
• Allocate agency resources effectively based on risk, leveraging the combined efforts of government, industry and public and private third parties. 30
Summary
Product safety and quality no longer begin or end at
the border
Shift to a public health regulatory agency fully
prepared for a complex, globalized regulatory
environment
Requires a strong, multifaceted strategic solution
Together, we’ll build a public health safety net for a
globalized economy31
Overview
President Obama signed FDASIA legislation on July 9, 2012
Provides for reauthorization of the following:
– Medical Device User Fee Act
– Prescription Drug User Fee Act
Establishes user fees for generic drugs and biosimilars.
The generic drug user fee amendment provisions in FDASIA
will have a major impact on ORA
Grants FDA the authority to review applications more expeditiously
Reauthorizes FDA’s authority to compel companies to conduct
pediatric clinical trials
Takes measures to end drug shortages
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What is the Generic Drug User Fee Amendment (GDUFA)?
GDUFA is an agreement between FDA and regulated industry to provide additional resources to the Agency, which will speed the review of generic drug applications.
During the five-year period from fiscal year 2013 through 2017, the generic drug industry will provide FDA an inflation-adjusted $299 million each year in user fees, supplementing the Agency’s allotted budget for assessing the safety of generic drugs.
By reducing the time it takes to determine whether a particular generic drug can be marketed in the United States, GDUFA will improve patient health and reduce uncertainty for industry
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Consumers and Industry
GDUFA will impose user fees on several areas:
– Applications that are pending as of October 1, 2012 at the FDA
– New applications coming in on or after October 1, 2012
– Drug master files
– Facilities – both domestic and foreign – involved in the manufacture of generic drugs
Companies involved in these areas will be required to pay fees
GDUFA is not expected to add more than $0.10 to the cost of a generic drug prescription.
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ORA Effect
• GDUFA• Increase number of inspections
• Hiring 80 new Investigators nationwide
• Drug Shortages• Enforcement actions
• Drug Supply Chain• Risk based inspection model
• Medical Device Improvements• Proactive information on recalls
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