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David Mittleman
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FDA Dropped the Ball on Protecting Consumers from Contaminated Syringes

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We already knew that under the Bush Administration, the Food and Drug Administration was underfunded and understaffed to the point of tragedy. But now we are slowly learning just how ill equipped the agency was to foster consumer safety, and what are the real costs of those decisions. The FDA failed to stop contaminated syringes from reaching consumers during several 2007 inspections of a North Carolina syringe production facility. The syringes were prefilled with Heparin, a blood thinner, and the distribution of the contaminated syringes resulted in four deaths and 162 illnesses nationwide.

An FDA inspector visited the plant three months prior to their shipping in October 2007 to investigate reports that the syringes contained red, brown, and black particles—signs of rust. Managers at the plant had previously been ordered by FDA officials to deal with the rust, except their method of sterilization was still unreliable when the inspector visited in October. A week later, the FDA learned the distributor was recalling 1.3 million syringes. This is specifically when the FDA should have launched a full-scale investigation, except it didn’t, claiming that the agency was so understaffed that it followed a policy whereby the agency did not inspect a product after a recall, unless the product posed a serious probability of injuries or deaths.

Federal prosecutors attempted to go after the president of the syringe company, but he fled the country to evade charges of fraud and conspiracy as well as other charges that he and his firm lied about performing sterility tests. If charged, he could have received up to 95 years in prison. However, two employees of the plant, including a plant manager, were sentenced to 4 ½ years each for fraud and for allowing tainted drugs onto the marketplace.

Many of the affected families have filed lawsuits against the syringe company, but this incident represents yet another case where the FDA failed to do their job during the Bush administration. It is becoming increasingly more difficult for critics not to point a finger at the FDA for “being in bed” with the very companies who produced products that could potentially harm consumers. Since the FDA decided to turn a blind eye, there was no one left to do the job of protecting the American public from hazardous medical devices or medicines, because as is becoming more clear by the day – Americans cannot count on corporations to regulate and police themselves any longer.