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FDA Looking Abroad to Boost Drug Safety

By Pharmaceutical Processing | June 3, 2009

TOMOKO A. HOSAKA Associated Press Writer TOKYO (AP) — The FDA has expanded offices around the world and heightened contacts with counterpart agencies in order to improve product safety for Americans at home, a senior agency official said Wednesday. Globalization has transformed the food supply as well as the manufacturing process of drugs and cosmetics, said Dr. Murray Lumpkin, the FDA’s deputy commissioner in charge of international programs. “What we now recognize … is that in order for us to do a better job at home, we have to do a better job with our counterpart agencies around the world,” he told reporters at the U.S. Embassy in Tokyo. Over the last several months, the FDA has established its first overseas posts in China, India, Latin America and Europe. “It shows our agency evolving from a very domestically focused agency historically to one now that realizes that it does have a place in a much more complex regulatory world,” said Lumpkin, in Tokyo for an annual meeting with Japanese officials. Its international foray represents a significant shift in strategy for the agency, which until now relied extensively on border inspections to identify unsafe goods. Inspection is a critical part of the process, but it can no longer serve as the first line of defense, Lumpkin said. The agency’s reputation has been tarnished in recent years, in part due to recurring outbreaks of food-borne illnesses that have undermined confidence in its oversight. Food scares out of China, including tainted milk products and pet food, have led U.S. lawmakers to call for greater regulation. Dr. Margaret Hamburg, confirmed as head of the FDA in mid-May, has said she wants to restore public confidence in the agency by putting science first and running an open and accountable operation.

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