Earlier in the week, we talked about the deadly meningitis outbreak that has claimed victims across the country. The rare fungal strain of the disease has been linked to a pharmaceutical compounder who has since recalled all of the medications it mixes at the location at which the tainted steroid injection was made. Though the recalls and the media spotlight on this serious disease will hopefully slow the infection rate, it is important to note that this is not the first time that this compounder has faced complaints.
Both in 2002 and 2003, the company faced complaints about their products. It is unclear whether their medications were making people sick or if there were similarly tainted lots of drugs, but in 2006 the company reached an agreement with governmental authorities to correct the problems.
The company seemed to be doing well: there were no risks found or complaints logged during a 2011 inspection. But by March 2012, there was another complaint about the potency medication used during eye procedures.
Surprisingly, it is not the federal Food and Drug Administration that has most of the control over a pharmaceutical compounder. Rather, state licensing boards regulate compounding facilities. Any investigation of a compounder who is accused of tampering with or tainting a batch of drugs would be investigated by the FDA with the assistance of the state.
As officials begin to look into this deadly outbreak of meningitis, the compounder who is in the middle of the investigation has agreed to suspend its operations.
Source: Reuters, "Deadly meningitis outbreak increases to 91 cases," Tim Ghianni, Oct. 7, 2012
Whether they are tainted drugs or defective automobiles, no one should have to worry about being injured by properly-used consumer products. Find out more about what we have done for the people who have unfortunately been injured by consumables by visiting our New York dangerous products page.