lunes, 1 de julio de 2013

Consumer Updates > FDA Forges Partnerships in Latin America

Consumer Updates > FDA Forges Partnerships in Latin America

FDA, U.S. Food and Drug Administration

FDA Forges Partnerships in Latin America

FDA Latin America Office meeting in Chile

Staff members in FDA's Latin America Office meet often with their regulatory counterparts in Latin America. Here, Michael Rogers (middle left side) and Edmundo Garcia (second, left side) meet with Chile's Minister of Agriculture Luis Mayol Bouchon (middle, right side) and his colleagues to discuss regulatory and public health issues that affect both nations. Get this photo on Flickr2.

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There's a good chance that some staple in your daily life—a food that you like or a medical product that you need—comes from Latin America.

To ensure that these foods are safe and these medical products are safe and effective, the Food and Drug Administration (FDA) has staff who represent the agency in 44 countries and territories within Mexico, Central America, South America and the Caribbean.

And that staff brings multi-tasking to a whole new level.

Latin American companies that manufacture, grow or process products regulated by FDA must meet the same federal standards applied to their U.S. counterparts. By working with local government and industry, FDA's Latin America Office (LAO) helps ensure that this critical safeguard is effective.

That's no small task.

"If you think about the 44 countries and territories that typically contain a Ministry of Health and a Ministry of Agriculture, that's 88 entities we have the opportunity to communicate with, sometimes on a daily basis," says Michael Rogers, LAO director. (Typically the Ministry of Health in each country covers medical products and processed foods, while the Ministry of Agriculture covers produce.)

Of all the products regulated by FDA, which include food, drugs, medical devices and others, about 30 percent come from the Latin American region. The percentage is even greater for fresh produce and seafood. Of the top 10 countries exporting fresh produce to the U.S., eight—Mexico, Guatemala, Chile, the Dominican Republic, Peru, Costa Rica, Honduras and Ecuador—are in Latin America.

LAO's challenge is made more complex by the fact that Latin America is so diverse, home to a wide variety of languages, cultures and economic realities, as well as a range of regulatory and public health systems.

LAO's Responsibilities

The LAO opened posts in San Jose, Costa Rica, and Santiago, Chile in 2009. A post in Mexico City opened in 2010. The post that focuses largely on Brazil operates from FDA headquarters in Silver Spring, Maryland. LAO's responsibilities and strategic objectives include:

  • developing contacts to ensure that FDA’s counterparts in Latin America and stakeholders from industry, commerce, agriculture and academia are informed about FDA regulations and processes affecting them;
  • establishing effective communication—in languages that include Spanish, Portuguese and English—with FDA's counterparts in each country;
  • working with headquarters in developing procedures for U.S. inspection of Latin American facilities involved in the production of FDA-regulated products, as well as working with local governments to join and follow up on FDA's inspections when significant problems are observed;
  • assisting FDA efforts in emergencies, such as a serious and widespread problem with an FDA-regulated product; and
  • coordinating with headquarters in fostering mutually beneficial partnerships related to laboratory testing for food safety.

Opening Lines of Communication

"Part of what we do is to figure out who the most relevant, knowledgeable and influential people are, whether in government, industry, commerce, agriculture or academia," says Edmundo Garcia, assistant regional director in Chile. "We know these people. We know these agencies. And they know us."

According to Lisa Lopez, assistant regional director in Costa Rica, key to these efforts are FDA foreign-service national employees who come from the country in which they serve. They not only speak the language literally, but they know the nuances of their culture and government, Lopez says.

Rogers says the agency's counterparts in Latin America benefit by understanding FDA's approach to product safety and quality. "I have seen that public health protection is a common language and mission between regulators," he says.

"In some cases, we have seen host governments take FDA's information about a noncompliant firm or product, and subsequently initiate their own action. These actions, taken under local law, not only maximize resources but far exceed what FDA can achieve on its own," Rogers says.

One thing that has helped enormously has been the establishment of a single e-mail address.

Poised to Respond

Staff members at each post collect information to better understand the laws and regulatory systems that exist within the 44 countries and territories. "In an emergency, such as a foodborne illness outbreak, we need to be well positioned and prepared to reach out to regulatory entities so they can help us understand the scope of the problem and what FDA's role will be in helping to restore safety," Rogers says.

"Further, we work with headquarters to assess what impact the affected products might have on the U.S," he adds. Should import inspectors be alerted? Are these products already in the U.S.? Is a recall needed?

On the other hand, Rogers says it is important that Latin American countries are well informed about essential U.S. regulatory initiatives, such as the landmark FDA Food Safety Modernization Act (FSMA), designed to prevent food safety problems before they occur.

"I see FSMA as an enormous game changer in the global marketplace of which Latin America is a key player," he adds. LAO staff has met frequently with Latin American counterparts in agriculture, public health and commerce to relay information about FSMA's role in ensuring that imported products are safe for U.S. consumers.

"I have a saying," Rogers says. "In some cases, what's old news to us is new news to the people who don’t have routine contact with the FDA. And so we are serving as the face of the agency to carry forward these messages."

This article appears on FDA's Consumer Updates page6, which features the latest on all FDA-regulated products.

July 1, 2013


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