1. Director, Latin America Office Food and Drug Administration
The U.S. Food and Drug Administration: FDA in Latin America: Overview, Goals, Objectives, Opportunities
Michael Rogers, M.S.
Director, Latin America Office
Food and Drug Administration

2. 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.
Summary of presentation

3. FDA Mission FDA 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.

4. 4

5. Mission and Vision of OIP
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.

7. FDA Resources Compared Imports
Lines in Thousands
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).

9. *Fuente: ORADSS (Datos no Oficiales)
Principales países latinoamericanos exportadores de productos regulados por FDA 2011*
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
En término de número de líneas de todos los productos bajo la jurisdicción de la FDA,
*Fuente: ORADSS (Datos no Oficiales) 9

10. 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

11. Algunas alertas de Importación que afectan productos alimenticios colombianos
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

12. Changing Nature of Risk in Global Supply Chains

13. 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?)

14. Partner with foreign counterparts to create global coalitions of regulators focused on ensuring and improving global product safety
Build global data information systems and networks and proactively share data with peers
Expand intelligence gathering, with an increased focus on risk analytics and thoroughly modernized IT capabilities
Effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry and public and private third parties

15. 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.

16. FDA Foreign Offices 16

18. 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

19. Today’s Reality 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

20. 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

21. 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

22. Contact Information and Questions
US Embassy Costa Rica
(506)
Michael Rogers, (506)