Richard J. Serpe, P.C. Blog

Richard J. Serpe, P.C. Blog

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Medical Malpractice

2/28/2008
Alexandrea Sumuel
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What’s going on at the FDA?
The Food and Drug Administration (FDA) has been in the news a lot lately, but not for good reasons.  Consider the latest news about Baxter’s drug heparin – heparin may be linked to 4 deaths and over 350 reports of adverse effects from the blood thinner.  As Baxter and the FDA try to determine if heparin is responsible for the deaths, troubling facts have come to light that cast the FDA in a poor light.
 
Probably the most surprising finding was that the FDA thought they had inspected the Chinese plant that supplies Baxter with the raw ingredients for heparin, however it was found later that a plant with a similar name was inspected instead.  This means that the factory supplying Baxter with the raw ingredients for heparin – which are derived from pig intestines – was never inspected by the FDA.
 
According to draft findings from a recent FDA inspection of the correct plant, the following troubling items were noted:
• A lack of specific procedures outlining removal of impurities.

• Workers reprocessed the drug that didn't meet specifications without determining what caused the initial problem.

• No records showing suppliers' source of the products.

• Some apparently improperly cleaned and maintained equipment.
 
With these latest findings, we have to wonder what is going on at the FDA.  This probably isn’t the last we’ll hear about trouble at the FDA because of mistakes and poor oversight.
 
What do you think can be done to fix problems at the FDA?  Are you concerned about this latest heparin debacle?  Leave us a comment and let us know.
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