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Associated Press

US, Europe, Australia Unite on Drug Inspections
July 10, 2008

WASHINGTON (AP) -- Faced with the globalization of drug production, the United States is joining with Europe and Australia to inspect factories in countries like China and India that make an increasing share of the active ingredients in medications.

Bush administration officials said Wednesday the agreement will allow regulators to coordinate their inspections and share information, thereby covering a wider territory and more foreign facilities.

"What we are seeing is the maturing of a global market, and we have to invent new tools to deal with a changing environment," Health and Human Services Secretary Michael Leavitt said.

The pilot program will concentrate primarily on facilities in third countries, such as China and India, which produce much of the world's pharmaceutical raw materials, but are sometimes beyond the reach of U.S. inspectors.

The globalization of pharmaceuticals took on new focus last spring after the blood thinner heparin — made with active ingredients from a Chinese facility — was linked to dozens of deaths and hundreds of severe allergic reactions in this country.

The drug was recalled by Baxter International and the U.S. blocked imports from the Chinese company.

The Food and Drug Administration found the heparin was contaminated with a nutritional supplement that costs less, but mimics the real drug in routine tests for potency, and thus was not detected. Investigators suspected deliberate contamination. The FDA had not previously inspected the Chinese facility because of a mix-up. And neither had Chinese drug safety regulators, because the plant was registered as a chemical factory.

The FDA expects to soon open offices in three Chinese cities — Beijing, Shanghai and Guangzhou. Thirteen employees would be assigned to work there.

Under the program announced Wednesday, authorities would share inspection schedules, results and other information. The goal is to try to reduce duplication and identify potential problems more quickly. The U.S., the European Union and Australia have similarly stringent safety standards, so coordinating inspections seemed like a natural next step.

"FDA and these trusted colleagues can spread our inspection net wider by leveraging our respective resources," Leavitt said. "Facilities will be inspected more often, and we can all focus more resources on those products that present higher risk." However, the FDA would still retain the option of going into a facility that already has been inspected by another country.

The agreement on third-country inspections is part of a broad effort to foster cooperation among U.S, European and Australian regulators. Officials are considering whether to limit production of certain "high risk" medications to designated facilities that meet specified standards. They also want to swap information more regularly on a wide range of drug development and safety issues.

Copyright 2008 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

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