понедельник, 11 февраля 2013 г.

FDA met with states’ representatives to discuss contamination with meningitis


The fungal meningitis outbreak that began in September last year had great influence upon America. Contaminated injectable steroids were manufactured by the New England Compounding Center (based in Massachusetts) and given to many persons. As a result, more than 400 persons sickened with fungal meningitis in over 20 states. 39 persons sickened with this disease died. 14 deaths were in Tennessee.
It became evident that it needed to do anything for prevention of such situations. Contamination must not occur in future. The FDA had to meet with representatives of all states for discussion of this situation. So, lately a conference took place in order to prevent occurring contamination in the future.
It was underlined during the meeting that new laws on compounding centers should be implemented.
Representatives of several states affirmed that they did proper job in their states and no any individual suffered from troubles related to contamination. Furthermore, they underlined with criticism that they didn’t know what happened in other states.
As for the FDA, its authority over such cases is limited. Federal court cases which were during past years cut the authority of the FDA obviously. In addition to these unpleasant aspects, several rules seem to be unclear.
Margaret Hamburg, the FDA Commissioner, offered to improve the situation through the following modifications:
- to manage training of state regulators;
- to promote sharing information between the FDA and states;
- to eradicate ambiguity from rules.

These proposals seem to be justifiable. Such modifications will probably help to promote improving public health of Americans. Undoubtedly, if rules contain ambiguity, no any agreement will be reached. That’s why new laws should be implemented and existing laws should be altered.
The FDA hopes that state regulators will collaborate with it in order to prevent manufacturing and shipping contaminated drugs.

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