Lawmakers Pledge to Raise More Money For Foreign Inspections

Scott Kappes
Contributor
(866) 735-1102 Ext 346
Posted by Scott KappesMay 02, 2008 5:29 PM
Tags: Heparin

After hearing tearful testimony this week of the family members who recently lost loved ones treated with contaminated batches of the popular blood-thinner Heparin. Heparin was recalled in February when it was discovered that some batches of the product had become contaminated. The contamination was traced back to a Chinese plant that produces the raw ingredients for the American manufacturer Baxter International. The FDA had never inspected the plant. The FDA now believed that the contamination was most likley intentional, in effort to cut costs and improve profits. It is apparent that more inspections are need to ensure the safety of foreign manufacturing plants, but the under funded agency has simply does not have the estimated $250 million it would take to perform the inspections.

 

One proposal would require drugmakers to pay fees to the U.S. Food and Drug Administration to boost capacity to check overseas manufacturing sites in an effort to keep counterfeit or contaminated drugs from reaching the U.S. market.

 

While this seems like a good option at face value, some lawmakers were concerned with the intricacies of the proposal, and called for better explanation of exact how the fee would be used.

 

Over 80 percent of active drug ingredients are produced abroad. With the recent recalls of Chinese toys for lead paint violations and contaminated pet foods, the recall of Heparin should be cause for some concern. The contaminated Heparin has already been linked to 81 deaths, and something must be done to ensure that this does not happen again in the future.

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