The fungal meningitis outbreak which started in September last year had serious influence upon America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and used by many persons. As a result, over 400 patients were contaminated with fungal meningitis in over 20 states. 39 persons contaminated with this disease died. 14 deaths happened in Tennessee.
It became evident that it needed to do something in order to prevent such cases. Contamination must not occur in future. The FDA had to meet with representatives of all states for discussion of this issue. So, recently a meeting took place in order to discuss ways related to prevention of contamination in the future.
It was specified during the meeting that new rules on compounding pharmacies should be introduced.
Representatives of some states claimed that they did proper job in their states and no any person suffered from troubles connected with contamination. Moreover, they noticed with criticism that they didn’t know what happened in other states.
When it comes to the FDA, its authority over such cases is not established well. Federal court cases which were during past years depressed the authority of the FDA significantly. In addition to these problems, some rules seem to be unclear.
Margaret Hamburg, the FDA Commissioner, expressed the proposal to improve the situation through the following modifications:
- to control training of state regulators;
- to promote sharing information between the FDA and states;
- to eradicate ambiguity from rules.
These items seem to be reasonable. Such modifications will probably help to promote improving public health of Americans. It goes without saying that if rules contain ambiguity, no any agreement will be reached. That’s why new laws should be elaborated and existing laws should be altered.
The FDA hopes that state regulators will coact with it in order to prevent manufacturing and shipping contaminated preparations.
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