The fungal meningitis outbreak that began in September last year had evident influence upon America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and used by numerous persons. As a result, over 400 individuals were contaminated with fungal meningitis in over 20 states. 39 persons sickened with this illness died. 14 deaths were in Tennessee.
It became evident that it needed to do anything for prevention of such cases. Contamination must not occur in future. The FDA had to meet with representatives of all states in order to discuss this problem. So, lately a conference took place in order to discuss ways related to prevention of contamination in the future.
It was noted during the meeting that new laws on compounding centers should be established.
Representatives of several states specified that they did proper job in their states and no any individual experienced problems connected with contamination. Moreover, they noticed critically that they didn’t know what occurred in other states.
As for the FDA, its authority over such situations is not established well. Federal court cases which were during past years reduced the authority of the FDA substantially. Furthermore, several laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, proposed to improve the situation through the following changes:
- to control training of state regulators;
- to induce sharing information between the FDA and states;
- to eliminate ambiguity from laws.
These items seem to be justifiable. Such modifications will probably help to promote improving public health of Americans. Of course, 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 hopes that state regulators will collaborate with it in order to prevent producing and shipping contaminated medicines.
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