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

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

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.

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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.

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).

*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

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

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

Changing Nature of Risk in Global Supply Chains

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?)

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 http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegulatoryOperationsandPolicy/GlobalProductPathway/UCM262528.pdf

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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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

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

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

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

Contact Information and Questions US-FDA-LAO@fda.hhs.gov US Embassy Costa Rica (506) 2519-2224 Michael Rogers, (506) 2519-2223