FDA in the Global Village
by Rebecca D. Williams

Charles A. Wayne, an FDA drug specialist, stands center court as the agency's  
premier globe-trotter.

Toting a leather satchel with "FDA" engraved on one side, Wayne has travelled  
to almost every country in the world to inspect foreign drug manufacturers,    
logging more miles in his 44-year career than any other FDA investigator.      
This year he has already traveled to South America and Europe, and now awaits  
his next assignment.

"I'll go wherever they send me," he says.

Few FDA employees travel as part of their jobs, and fewer still travel as      
often as Wayne, but a certain group of investigators, scientists and           
administrators carry the agency's work outside our nation's borders.

They may conduct inspections in the rugged mountains of Peru, contact health   
officials in Japan by fax and phone, or engage in regulatory-related           
activities in remote corners of the globe. Next year, FDA plans to triple its  
inspections overseas and significantly increase other contacts with foreign    
governments.

"We have worked with every country in the world over the years in some         
fashion, even if it's just to give information," says Walter Batts, director   
of FDA's International Affairs Staff, which coordinates much of the agency's   
work with foreign governments.

FDA's international activities involve three main goals: to ensure that        
imported products are safe and effective, to offer foreign countries           
technical assistance in product regulation, and to work toward unifying        
standards around the world for food, drugs and medical devices.

Inspecting Foreign Manufacturers

FDA has conducted foreign inspections for more than 30 years.

In the late 1950s, FDA inspected only firms that produced antibiotics made     
overseas, but it has since added inspections of food, drug and medical device  
companies to make sure their products are safe for American consumers.

Inspecting these abroad, however, is much different than in the United States.

Because foreign travel requires careful advance planning, FDA can't drop in    
unexpectedly to inspect foreign manufacturers. It also cannot seize goods and  
prosecute offenders overseas because the agency has no judicial leverage over  
foreign manufacturers.

So, to monitor imports, FDA uses "the back door approach," says Richard Klug,  
who supervises international inspections in FDA's Office of Regulatory         
Affairs. 

Before any drugs or medical devices from abroad can be sold in the United      
States, they must earn FDA approval and their manufacturers must pass FDA      
inspection.

Foreign companies that want to sell their products in the United States        
usually welcome FDA investigators, Klug says.

"Generally, I think they respect FDA in foreign countries," says Klug. "We     
are very well received."

Overseas inspections are the responsibility of FDA's "international cadre," a  
team of about 80 investigators and 15 experts from among the agency's regular  
investigators. Like Charles Wayne, they travel overseas weeks, sometimes       
months, each year.

Several international investigators speak foreign languages, but most speak    
English or use interpreters when they travel. That's why in addition to        
technical proficiency, cadre investigators must practice tact and patience.

"When they go overseas, they're representing the United States, not just       
FDA," Klug says. "It's a select group."

The international cadre often returns with harrowing tales.

John Rubright, an investigator from Philadelphia, for example, made his first  
overseas inspection last February. He landed in Tokyo's airport in the middle  
of a snowstorm, only to endure an earthquake just hours later at his hotel.

"I was horrified," Rubright remembers. "The Japanese said I should feel very   
lucky to have experienced both a snowstorm and an earthquake in one day, but   
I was pretty scared."

Although most trips are not as eventful as Rubright's, some international      
investigations have been dangerous, even tragic. In 1990, during an            
investigation of the Chilean grape industry, John Harty Jr., director of       
FDA's International Affairs Staff, and Patrick Pouzar, director of             
investigations in FDA's Nashville district office, died when their small       
plane crashed in the Andes Mountains.

At a memorial service honoring Harty and Pouzar, the two were awarded the      
Secretary's Recognition Award "for stalwart, stellar service to all of         
mankind." In their memories, then-acting FDA Commissioner James Benson         
announced the establishment by FDA of an international education program to    
improve public health protection in Latin America and the Caribbean.

Help to Countries in Need

In addition to conducting foreign inspections, FDA lends technical assistance  
to many countries that need scientific advice or training.

For three years, FDA consumer safety officer Edwin Rivera-Martinez             
practically lived out of his suitcase, traveling around Latin America to       
train officials of those countries in proper drug manufacturing practices,     
quality control, and inspection techniques.

With funding from the Pan American Health Organization, Rivera-Martinez, then  
stationed in FDA's San Juan district, helped set up five month-long training   
courses in Guatemala, Colombia, Costa Rica, Brazil, and Equador for nearly     
250 officials. The students then used their training to teach others what      
they'd learned.

"I think the project had a dramatic impact," Rivera-Martinez said. "Whenever   
an FDAer goes abroad, his or her presence is perceived in a positive way."

The agency has also traveled overseas in times of emergency.

In the past year, FDA has given advice on food safety to South American        
countries hit by a cholera epidemic. An FDA official traveled to Russia to     
review vaccine-making capabilities in light of that country's recent           
political upheaval. And the agency has worked with Egypt and Saudi Arabia to   
help them establish better quality control methods in vaccine manufacturing.

"By and large, we will work with all countries except those in which there     
are government restrictions, such as Iraq or Libya," says Batts. "However, we  
evaluate requests carefully to weigh the impact on FDA resources against the   
contribution to our mission and U.S. government policies."

FDA officials have traveled to Cuba, for instance, to work on medical device   
regulations. They have gone to Taiwan, a country not officially recognized by  
the United States, and to India and Thailand, even though relationships with   
those countries are strained by disagreements over copyright and patent laws.

In 1991, FDA brought 600 foreign visitors to the United States, from           
high-level health officials eager to talk about FDA policy to laboratory       
technicians who needed hands-on training.

By way of a computerized communications link through the Department of State   
and regular mailings to embassies and foreign health officials, FDA also       
informs and receives information from other countries about recalls, new       
policies and regulations, and health hazards.

International Harmonization

Inspections and technical assistance are not FDA's only international          
concerns, however. The agency is also working to establish standard            
regulations worldwide for products it regulates. Among negotiators, this       
effort is called "international harmonization."

Regulations governing food, drugs and medical devices now vary widely among    
countries. International harmonization may speed new drug and medical device   
approvals, help FDA use its resources more efficiently, and ease trade         
restrictions between nations.

For example, FDA has agreements with some countries to exchange data from      
drug testing so that scientists don't have to duplicate efforts. Recently,     
the United States and Canada worked together to evaluate DDI, a drug to        
combat the AIDS virus. Both countries approved the drug in record time and on  
the same date.

FDA is negotiating especially with Japan and the European Community to         
harmonize drug testing requirements, since 90
 percent of drugs come from those countries and the United States.

FDA employees also participate in international conferences sponsored by the   
World Health Organization, and in a number of international trade              
negotiations. 

"It's important for us to be involved in the trade talks to make sure FDA's    
mandate isn't compromised," says Batts, FDA's primary negotiator at the North  
American Free Trade Agreement talks between Canada, Mexico, and the United     
States.

FDA welcomes the opportunity to participate in trade negotiations. However,    
it doesn't intend to relax standards on the products it regulates to improve   
trade at the expense of public health.

"Clearly," Batts adds, "FDA's mandate is to protect the public health from     
unsafe, ineffective, or poor-quality products."

Future International Affairs

The future of FDA's international activities, particularly concerning          
international harmonization, is currently under study by an agency task        
force. Although the task force's recommendations were not complete when this   
article went to press, proposals to improve FDA's monitoring of the            
increasing amount of imported food, drugs and medical devices will likely be   
among them.

The agency's international affairs staff has increased from two people only    
handling foreign visitors in the late 1970s to a staff of 16 today. Some       
industry groups have suggested that FDA station employees in Europe and        
Mexico to coordinate regulatory issues and technical cooperation overseas.

In any event, the task of harmonizing international regulations, says Batts,   
will give lasting benefits to FDA and the American public.

"[With harmonization], we can make better use of information from other        
countries, approve products faster, and regulate imports more effectively,"    
Batts says.

"In the future, FDA is going to be much more involved in activities with       
other countries and international organizations."

Rebecca D. Williams is a staff writer for FDA Consumer.