The U S Food and Drug Administration FDA

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 1

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. 2

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. 3

4 4

Mission and Vision of OIP Vision • 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. 5

6

Lines in Thousands FDA Resources Compared Imports 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). 7

8

Principales países latinoamericanos exportadores de productos regulados por FDA 2011* PAIS Mexico República Dominicana Chile Guatemala Costa Rica Colombia Brasil El Salvador ENTRADAS 7, 970, 177 137, 520 121, 529 113, 100 108, 364 89, 774 88, 380 9 *Fuente: ORADSS (Datos no Oficiales) 81, 114

Principales causas de rechazos de productos colombianos 2011 Ø Medicamentos no aprobados Ø Colores no inocuos Ø Etiquetado: no en inglés, ingredientes no listados y errores en general Ø LACF: sin FCE ni SID Ø Plaguicidas Ø Falta etiquetado nutricional 10

Algunas alertas de Importación que afectan productos alimenticios colombianos http: //www. accessdata. fda. gov/CMS_IA/countr y_CO. html Ø Quesos: contaminación microbiológica Ø Aletas de tiburón: suciedad Ø Pez espada: metil mercurio Ø Tamarindo: suciedad Ø Hojas de Stevia Ø Colores: ilegales o no declarados Ø Pescado a vacío: C. botulinum Ø Violaciones a NLEA Ø Aflatoxinas en alimentos general Ø Frutas y vegetales frescos: contaminación con patógenos Ø Plaguicidas en alimentos frescos y procesados: lulo, mora, fresa, uchuva, albahaca Ø Salmonella: te de manzanilla, albahaca 11

Changing Nature of Risk in Global Supply Chains 12

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? ) 13

http: //www. fda. gov/downloads/About. FDA/Centers. Offices/Officeof. Global. Regulatory. Operationsan d. Policy/Global. Product. Pathway/UCM 262528. pdf 14

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. 15

FDA Foreign Offices 16

17

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 18

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 19

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 20

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 21

Contact Information and Questions • US-FDA-LAO@fda. hhs. gov • US Embassy Costa Rica (506) 2519 -2224 • Michael Rogers, (506) 2519 -2223 22