Personal Injury Law

Contaminated Chinese Heparin

At least19 people have died, and hundreds became ill after being given heparin, a blood-thinning drug sold by drug manufacturer Baxter International. Baxter obtained the drug?s active ingredient from a Chinese manufacturer.

A belated inspection of the Chinese plant found substandard conditions. Recent lab tests revealed an unknown contaminant in batches of the drug, but researchers have not identified what precisely caused the allergic reactions which caused the deaths.

The Food and Drug Administration is required to inspect plants such as the one in China which supplied the heparin ingredient. However, under the Bush Administration, it has failed to follow this mandate.

Currently, 80 percent of all active drug ingredients come from abroad, but the FDA doesn't know what percentage of foreign manufacturing facilities it has inspected. Many of these plants are in developing countries that don't have infrastructure that meets U.S. safety standards.

Critics of the FDA argue that the FDA doesn't have the resources to meet its statutory mandate to inspect domestic plants every two years, let alone inspect plants abroad. A recent Government Accountability Office report estimated that the FDA can inspect foreign firms on average once every 13 years. They point out that the agency uses antiquated, incomplete databases which led officials to believe they'd already inspected the heparin plant in China when actually they'd been to one with a similar name.

These critics argue that the FDA needs more money, either through Congressional appropriations or user fees. But, they also point out that last year Congress gave the FDA more money than the Bush administration had asked for.

Full post as published by Georgia Injury Lawyer Blog on March 17, 2008 (boomark / email).