Presentation on theme: "Director, Latin America Office Food and Drug Administration"— Presentation transcript:
1 Director, Latin America Office Food and Drug Administration The U.S. Food and Drug Administration: FDA in Latin America: Overview, Goals, Objectives, OpportunitiesMichael Rogers, M.S.Director, Latin America OfficeFood and Drug Administration
2 FDA in Latin America Overview: FDA’s organization and Mission Office of International ProgramsHistory and overview of FDA offices overseasstructure of the FDA Latin American Office (LAO).Challenges of GlobalizationThe triggering factors → InternationalRoles and Responsibilities of LAOOngoing ActivitiesFuture OpportunitiesIdentifying sources and ways to obtain information about FDA regulated products within the RegionWorking 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.VisionFDA 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.
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.MissionOIP'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 ThousandsLines 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*PAISENTRADASMexico7,970,177República Dominicana137,520Chile121,529Guatemala113,100Costa Rica108,364Colombia89,774Brasil88,380El Salvador81,114Perú74,662En 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 aprobadosColores no inocuosEtiquetado: no en inglés, ingredientes no listados y errores en generalLACF: sin FCE ni SIDPlaguicidasFalta etiquetado nutricional
11 Algunas alertas de Importación que afectan productos alimenticios colombianosQuesos: contaminación microbiológicaAletas de tiburón: suciedadPez espada: metil mercurioTamarindo: suciedadHojas de SteviaColores: ilegales o no declaradosPescado a vacío: C. botulinumViolaciones a NLEAAflatoxinas en alimentos generalFrutas y vegetales frescos: contaminación con patógenosPlaguicidas en alimentos frescos y procesados: lulo, mora, fresa, uchuva, albahacaSalmonella: 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 syrupSalmonella in mamey pulp, peppers, cantaloupes, etc.Counterfeit diabetic test stripsGentamicin pyrogenic reactionsHeparin (Condroitin Sulfate adulterant?)
14 Partner with foreign counterparts to create global coalitions of regulators focused on ensuring and improving global product safetyBuild global data information systems and networks and proactively share data with peersExpand intelligence gathering, with an increased focus on risk analytics and thoroughly modernized IT capabilitiesEffectively 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 Offices7 foreign officesAsia Pacific, China, India, Europe, Middle East and North Africa, and Sub-Saharan Africa, Latin America Office (LAO)administrative offices in MarylandLAOJanuary 6, 2009First office officially dedicated at the US Embassy in San José, Costa RicaCeremony attended by Leavitt, Von Eschenbach, Valdez and Seligman.Trip includes a visit to the Gorgas Research Institute in Panamá City, Panamá.
18 Regulatory Challenges for FDA more imported productsmore international providers of these productsmore international sub-contractors being used for manufacturing and clinical trialsmore complex supply chainsimports coming from countries, whose regulatory systems are not fully developedmore opportunity for economic fraud, counterfeiting, acts of bioterrorism
19 Today’s Reality Import Statistics Borders can no longer be a first line of defenseIt is very difficult to detect harmful products at the borderProducts grown, processed, manufactured, tested, transported to standards of safety & high quality – best defenseprimary preventionbuild in safety & quality at the source
20 Ongoing Activities Country profiles Validating contacts within the RegionBuild capacity and an understanding of foreign regulatory systemsEnvironmental ScansProject to enhance the class 1 recall processAnalytical PapersPresentations and Translating documentsTraining on FSMACollaboration with industry
21 Future Activities Pathway to Global Product Safety and Quality InspectionsProduct mappingRecallsIdentifying 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 QuestionsUS Embassy Costa Rica(506)Michael Rogers, (506)