1

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

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.

3

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.

44

5

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.

6

7

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).

8

0

500

1000

1500

2000

2500

2008 2009 2010 2011

Fiscal Year

Foreign Inspections

9

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

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

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

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

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

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.

1616

FDA Foreign OfficesFDA Foreign Offices

17

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

• 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

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

• US-FDA-LAO@fda.hhs.gov

• US Embassy Costa Rica(506) 2519-2224

• Michael Rogers, (506) 2519-2223

Contact Information and Questions