EU urges more collaboration after Heparin scandal
June 9, 2008
According to Reuters, Western drug agencies need to step up cooperation to head off a repeat of the recent scandal over tainted Heparin and protect patients from counterfeits, Thomas Lonngren, the head of the European Medicines Agency, said recently.
Part of the answer may be joint programs of inspections of foreign factories by Western watchdogs.
According to Lonngren, the U.S. Food and Drug Administration had agreed this week to join a pilot project with Europe, Canada and Australia to work together in inspecting overseas plants making active pharmaceutical ingredients, or APIs.
APIs are the basic chemical ingredients of medicines, many of which are now made cheaply in China and India.
Chinese-made Heparin, a blood thinner, has been blamed for fatalities and adverse reactions in U.S. and German patients. In the United States, tainted Heparin from China was used by at least 81 patients who died, prompting a recall by Baxter International Inc.
Much lower -- and generally safe -- levels of impurities have also been found in some batches of Sanofi-Aventis''s drug Lovenox.
Baxter''s Heparin recall was the latest in a string of problems with Chinese-made products that have highlighted oversight gaps in China, causing worries in the West over how drugmakers control foreign manufacturing.
Lonngren said both the pharmaceuticals industry and regulators had to be vigilant as more and more production shifted to Asia, and that there is the need for global cooperation.
Such cooperation would also help stamp out the threat of counterfeit medicines, which are increasingly entering the supply chain in developing countries and, to a lesser extent, the industrialized world.