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понедельник, 11 февраля 2013 г.

Contaminated steroids led to essential problems in America


The fungal meningitis outbreak which began in September last year had serious influence upon America. Contaminated injectable steroids were manufactured by the New England Compounding Center (located in Massachusetts) and used by a lot of persons. As a result, over 400 patients were contaminated with fungal meningitis in over 20 states. 39 individuals sickened with this disease died. 14 deaths happened in Tennessee.
It became obvious that it was necessary to do anything in order to prevent such cases. Contamination must not occur in future. The FDA had to meet with representatives of all states in order to discuss this situation. So, lately a meeting took place in order to prevent occurring contamination in the future.
It was noticed during the conference that new rules on compounding pharmacies should be elaborated.
Representatives of some states affirmed that they did suitable job in their states and no any person experienced problems connected with contamination. Furthermore, they underlined critically that they didn’t know what occurred in other states.
When it comes to the FDA, its authority over such situations is limited. Federal court cases which were during past years exhausted the authority of the FDA essentially. In addition to these problems, 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 eradicate ambiguity from rules.

These points seem to be justifiable. Such changes must 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 rules should be modified.
The FDA hopes that state regulators will collaborate with it in order to prevent manufacturing and shipping contaminated medicines.

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