Heparin Investigation Highlights More Holes in Drug Safety System

Statement

Heparin Investigation Highlights More Holes in Drug Safety System

Congresswoman Rosa L. DeLauro (CT-3), chairwoman of the House Agriculture, Rural Development, Food and Drug Administration Appropriations Subcommittee, issued the following statement about recent reports that a Chinese facility, which has not been inspected by the FDA, made the active ingredients in a blood-thinner, heparin, tied to four deaths and hundreds of allergic reactions.

"It was almost one-year ago that the American people began encountering problems with tainted pet food imported from China . A few weeks ago, we learned about contaminated leukemia drugs also from China . Today, we discover that the widely-used blood thinner, heparin, under investigation after reports of hundreds of allergic reactions and four deaths among the drug's users, includes an ingredient from a Chinese facility that has not been inspected by the FDA.

"The American people would expect the FDA to at least know which facilities ship drug ingredients to the United States . Unfortunately, the agency does not even know how many facilities this might include. Given that China is the world's largest producer of active pharmaceutical ingredients, this is a significant cause for concern.

"Despite the Cabinet-level working group created by the President last year, this Administration does not appear to take seriously the need to ensure the safety of drug imports as evidenced by the lack of resources included in the President's budget for the FDA. Congress increased the FDA's budget for 2008 by over $145 million from 2007, including an increase of $21.1 million for drug safety. However, in its FY 2009 budget request, the Administration proposed only a $2.6 million increase for FDA drug safety field activities, yet further indication of this Administration's disregard for funding activities that ensure the safety of our food supply and prescription drugs."

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