The Angiers, NC company AM2PAT sold tainted syringes of heparin and saline resulting in at least 5 deaths, and leading to the guilty pleas of 2 employees this week in U.S. District Court. Today's article in the News & Observer reports that numerous complaints about cloudy, off-color drugs and debris in the syringes had been made to the FDA as early as 2005, but that the agency didn't order a recall of the drugs that caused the deaths until December 0f 2007. This, despite the fact that the FDA had already recalled some batches in January of 2007, citing "an ongoing fda inspection of am2pat inc's facility". Days after the recall, the General Accounting Office presented testimony at a Congressional hearing, detailing the FDA's failure to inspect these sorts of labs at least every 2 years, as it is mandated to do.
The FDA's website has a great search engine for recalls, and offers an rss feed for all recalls. The GAO makes reports and testimony available on its website, but can be difficult to navigate if you don't know the report number or the date of release. One lazy way around this is to call up the reporter and ask for her source. If she's very nice, like Sarah Avery is, she may give you the info you need to find it online (thank you, SA)!
Wednesday, February 25, 2009
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