Baxter Labs has temporarily stopped making the blood thinner heparin because of adverse reactions. Part of the investigation involves China, and questions are being raised about the inspection process of the FDA: is it a little too thin perhaps? WSJ:

Baxter International Inc.’s investigation into the cause of deaths and allergic reactions linked to its blood-thinner heparin is focusing on variations in batches of the active ingredient for the drug, most of which were supplied by a Chinese manufacturing facility co-owned by a Wisconsin company…Heparin is a complex sugar molecule that normally exists on the lining of blood vessels in people and animals. It is now made from pig intestines, but processing them can lead to impurities. “Crushing tissue to get extracts means you can get contamination from other things in the tissue,” says John R. Hess, a blood expert at the University of Maryland…

China’s rise to become the world’s largest manufacturer of drug ingredients has helped drug companies elsewhere trim production costs, particularly for generic products like heparin, where margins are generally slim. Changzhou SPL, also known by its Chinese name, Kaipu Biochemical Co., is one of hundreds of Chinese manufacturers that have quietly become a linchpin of the global pharmaceutical industry. In 2005, China had $4.4 billion, or 14%, of the world’s $31 billion market for active pharmaceutical ingredients, topping India and Italy, according to a report written last year by Jinsong Du, a health-care analyst in Hong Kong with Credit Suisse…

The FDA isn’t legally required to inspect every foreign drug facility, but it generally does examine them if they are named as a maker in a new application to market a drug in the U.S. If the holder of an existing, approved application switches manufacturers, the new facility would usually get inspected as well. However, a legal requirement for drug manufacturers to get inspected every two years applies only to domestic plants, not the growing list of overseas facilities.

The FDA apparently inspects only about 2% of Chinese facilities that are making drugs or their ingredients that are exported to the US, as the chart above indicates. On the surface, this would appear to be some cause for concern, given the problems that China has experienced with other exports.

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