The fungal meningitis outbreak that started in September last year had evident influence upon America. Contaminated injectable steroids were produced by the New England Compounding Center (based in Massachusetts) and administered by many persons. As a result, over 400 persons were contaminated with fungal meningitis in over 20 states. 39 individuals sickened with this disease died. 14 deaths happened in Tennessee.
It became evident that it needed 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 for discussion of this problem. Thus, recently a meeting took place in order to prevent occurring contamination in the future.
It was affirmed during the meeting that new laws on compounding centers should be elaborated.
Representatives of several states said that they did suitable job in their states and no any individual suffered from problems linked with contamination. Furthermore, they specified critically that they didn’t know what happened in other states.
When it comes to the FDA, its authority over such cases is not established properly. Federal court cases which were during past years weakened the authority of the FDA essentially. In addition to these unpleasant aspects, certain rules seem to be unclear.
Margaret Hamburg, the FDA Commissioner, proposed to improve the situation through the following modifications:
- to improve training of state regulators;
- to induce sharing information between the FDA and states;
- to remove ambiguity from laws.
These points seem to be prudent. Such changes will probably help to promote improving public health of Americans. It goes without saying that if laws contain ambiguity, no any agreement will be reached. That’s why new rules should be elaborated and existing rules should be altered.
The FDA believes that state regulators will cooperate with it in order to prevent producing and shipping contaminated preparations.
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