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FDA Refuses To Give Budget For Modernizing Plan

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At a Senate hearing several weeks ago, Janet Woodcock, director of the Food and Drug Administration’s Center for Drug Evaluation and Research, assured the American public that the heparin found in the United States is safe. Heparin is a blood-thinning drug sold by Baxter International. It is believed to have been tainted by a contaminant in the active ingredients of the batches being processed by one of Baxter’s Chinese suppliers. The FDA says it never investigated this plant due to a clerical error. However, the agency does admit if they had investigated the facility they still probably would not have found anything wrong since the heparin contaminant appeared chemically identical to genuine heparin in initial testing. This contaminant has led to eighty-one deaths in the United States alone.

 

            Woodcock’s reassurance, however, was met with a warning to the Senate Health, Education, Labor, and Pensions Committee that the FDA is underfunded, a 20h-century domestic agency battling to protect American consumers in a globalized, 21st-century world. She asks that the FDA be given more inspectors, modern information technology systems and enhanced science. Dr. Woodcock, however, would not give the Senate a specific price of how much money the FDA needed for the task. By the end of the year, the FDA is set to open three offices in China, staffed with thirteen inspectors.  http://www.washingtonpost.com/wp-dyn/content/article/2008/04/26/AR2008042601662_pf.html