The fungal meningitis outbreak which began in September last year had evident impact upon America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and introduced by many persons. As a result, more than 400 patients sickened with fungal meningitis in more than 20 states. 39 persons contaminated with this illness died. 14 deaths occurred in Tennessee.
It became evident that it was necessary to do anything for prevention of such situations. Contamination must not take place in future. The FDA had to meet with representatives of all states in order to discuss this situation. So, recently a conference took place in order to prevent occurring contamination in the future.
It was noted during the conference that new rules on compounding centers should be established.
Representatives of some states underlined that they did suitable job in their states and no any individual suffered from problems linked with contamination. Moreover, they noted critically that they were not aware of what happened in other states.
As for the FDA, its authority over such cases is limited. Federal court cases that were during past years cut the authority of the FDA significantly. Furthermore, some laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, offered to improve the situation through the following modifications:
- to control training of state regulators;
- to promote sharing information between the FDA and states;
- to get rid of ambiguity in laws.
These items seem to be prudent. Such modifications must help to promote improving public health of Americans. Undoubtedly, if rules contain ambiguity, no any agreement will be achieved. That’s why new laws should be introduced and existing laws should be modified.
The FDA hopes that state regulators will coact with it in order to prevent producing and shipping contaminated preparations.
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