U.S., Europe, Australia to expand drug inspections

Tag : factories china
WASHINGTON – Faced with the globalization of drug production,the United States is joining with Europe and Australia to inspectfactories in China and India that make raw materials formedications.
Bush administration officials said Wednesday the agreement willallow regulators to cover a wider territory and inspect moreplants.
“What we are seeing is the maturing of a global market and wehave to invent new tools to deal with a changingenvironment,” Health and Human Services Secretary MichaelLeavitt said.
The pilot program will concentrate first on facilities in China andIndia.
The reach of U.S. inspectors took on new focus last spring afterthe blood thinner heparin – made with Chinese ingredients– was linked to dozens of deaths and hundreds of allergicreactions. The drug has been recalled by Baxter International andthe U.S. has blocked imports from the Chinese company.
The Food and Drug Administration found the drug was contaminatedwith oversulfated chondroitin sulfate, which mimics heparin andthus was not detected in routine testing.
The FDA wants to establish foreign offices in three Chineselocations – Beijing, Shanghai and Guangzhou. Thirteenemployees would be assigned to work there.
The program announced Wednesday with Europe and Australia wouldgive FDA the option of going into a facility that already has beeninspected by another country's inspectors.