1 the u.s. food and drug administration: fda in latin america: overview, goals, objectives,...
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The U.S. Food and Drug Administration:
FDA in Latin America:Overview, Goals, Objectives, Opportunities
Michael Rogers, M.S.Director, Latin America OfficeFood and Drug Administration
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FDA in Latin America • Overview:
– FDA’s organization and Mission• Office of International Programs
– History and overview of FDA offices overseas
• structure of the FDA Latin American Office (LAO). – Challenges of Globalization
• The triggering factors → International• Roles and Responsibilities of LAO
– Ongoing Activities– Future Opportunities
• Identifying sources and ways to obtain information about FDA regulated products within the Region
• Working with industry and foreign governments.
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FDA MissionFDA Mission• FDA is charged with protecting the public health by ensuring the safety,
effectiveness, and security of human and veterinary drugs, biological products, and medical devices; ensuring the safety of foods, cosmetics, and radiation-emitting products; and regulating tobacco products.
• Specifically, FDA is responsible for advancing the public health by:– Helping to speed innovations that make foods safer and make medicines and
devices safer and more effective;– Ensuring the public has accurate, science-based information they need to use
medicines, devices, and foods to improve their health;– Regulating the manufacture, marketing, and distribution of tobacco products and
reducing tobacco use by minors; and,– Addressing the Nation’s counterterrorism capability and ensuring the security of
the supply of foods and medical products.Vision• FDA is dedicated to world-class excellence as a science-based regulatory
agency with a public health mission. We aim to provide effective and innovative leadership — both domestically and internationally — to protect health, prevent illness, prolong life, and promote wellness.
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Mission and Vision of OIPVision• The FDA's Office of International Programs (OIP) advances the
mission of the FDA and public health worldwide in partnership with other FDA components, other U.S. agencies, foreign governments and international organizations.
Mission• OIP's mission is to lead, manage, and coordinate all of FDA's
international activities, with the following goals.• Effect an affirmative public health agenda in the international area; • Enhance and maximize FDA's communications and interactions
globally, to assure they reflect the Agency's policies and best scientific, legal, and policy thinking;
• Assure that FDA international communications and interaction are consistent with the U.S. Department of Health and Human Services public health objectives, and,
• Leverage resources with counterpart agencies to meet our public health missions.
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FDA Resources Compared Imports
0
5,000
10,000
15,000
20,000
25,000
1995 1997 1999 2001 2003 2005 2007 2009 2011est
Fiscal YearFTEs LINES
Lin
es
in T
ho
usa
nd
s
Lines are shipments of a certain type of product (i.e. if a container includes 1 million bottles of water and 5 million bottles of club soda, that would be one entry containing two lines).
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0
500
1000
1500
2000
2500
2008 2009 2010 2011
Fiscal Year
Foreign Inspections
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Principales países latinoamericanos exportadores de productos regulados por
FDA 2011*
*Fuente: ORADSS (Datos no Oficiales)
PAIS ENTRADAS
Mexico 7,970,177
República Dominicana 137,520
Chile 121,529
Guatemala 113,100
Costa Rica 108,364
Colombia 89,774
Brasil 88,380
El Salvador 81,114
Perú 74,662
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Principales causas de rechazos de productos colombianos 2011
Medicamentos no aprobados Colores no inocuos Etiquetado: no en inglés, ingredientes no listados y errores
en general LACF: sin FCE ni SID Plaguicidas Falta etiquetado nutricional
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Algunas alertas de Importación que afectan productos alimenticios colombianos
http://www.accessdata.fda.gov/CMS_IA/country_CO.html
Quesos: contaminación microbiológica
Aletas de tiburón: suciedad Pez espada: metil mercurio Tamarindo: suciedad Hojas de Stevia Colores: ilegales o no declarados Pescado a vacío: C. botulinum
Violaciones a NLEA Aflatoxinas en alimentos general Frutas y vegetales frescos:
contaminación con patógenos Plaguicidas en alimentos frescos
y procesados: lulo, mora, fresa, uchuva, albahaca
Salmonella: te de manzanilla, albahaca
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Changing Nature of Risk in Global Supply Chains
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Latest wakeup calls• Melamine in pets foods and in infant formula• Listeria in cheese, guacamole, etc.• DEG in toothpaste, in glycerin used in teething
gel and in cough syrup• Salmonella in mamey pulp, peppers,
cantaloupes, etc.• Counterfeit diabetic test strips• Gentamicin pyrogenic reactions• Heparin (Condroitin Sulfate adulterant?)
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http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf
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History of FDA’s Latin American Office
• OIP’s Foreign Offices– 7 foreign offices
– Asia Pacific, China, India, Europe, Middle East and North Africa, and Sub-Saharan Africa, Latin America Office (LAO)
• administrative offices in Maryland
• LAO– January 6, 2009
• First office officially dedicated at the US Embassy in San José, Costa Rica
• Ceremony attended by Leavitt, Von Eschenbach, Valdez and Seligman.
• Trip includes a visit to the Gorgas Research Institute in Panamá City, Panamá.
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FDA Foreign OfficesFDA Foreign Offices
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Regulatory Challenges for FDA
• more imported products• more international providers of these products• more international sub-contractors being used
for manufacturing and clinical trials• more complex supply chains• imports coming from countries, whose regulatory
systems are not fully developed• more opportunity for economic fraud,
counterfeiting, acts of bioterrorism
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• Import Statistics• Borders can no longer be a first line of defense• It is very difficult to detect harmful products at
the border• Products grown, processed, manufactured,
tested, transported to standards of safety & high quality – best defense– primary prevention– build in safety & quality at the source
Today’s Reality
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Ongoing Activities• Country profiles• Validating contacts within the Region• Build capacity and an understanding of foreign
regulatory systems• Environmental Scans• Project to enhance the class 1 recall process• Analytical Papers• Presentations and Translating documents• Training on FSMA• Collaboration with industry
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Future Activities
• Pathway to Global Product Safety and Quality• Inspections• Product mapping• Recalls• Identifying sources of information within the
Region that have a direct impact on FDA regulated products or firms shipping to the U.S.
• Leverage information generated by foreign governments
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• US Embassy Costa Rica(506) 2519-2224
• Michael Rogers, (506) 2519-2223
Contact Information and Questions