FDA in the Global Village

by Food and Drug Administration (FDA)

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.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.