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понедельник, 11 февраля 2013 г.

Ambiguity should be disposed from rules on pharmacies


The fungal meningitis outbreak which started in September last year had obvious influence upon America. Contaminated injectable steroids were produced by the New England Compounding Center (based in Massachusetts) and introduced by a lot of persons. As a result, over 400 individuals were contaminated with fungal meningitis in over 20 states. 39 persons contaminated with this illness died. 14 deaths occurred in Tennessee.
It became obvious that it was necessary 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 situation. So, lately a meeting took place in order to find ways linked with prevention of contamination in the future.
It was noticed during the conference that new rules on compounding pharmacies should be elaborated.
Representatives of some states specified that they did proper job in their states and no any individual experienced troubles related to contamination. Furthermore, they noted critically that they were not aware of what happened in other states.
When it comes to the FDA, its authority over such situations is not established appropriately. Federal court cases that were during past years cut the authority of the FDA substantially. Furthermore, several 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 induce sharing information between the FDA and states;
- to remove ambiguity from laws.

These points seem to be justifiable. Such changes must help to induce improving public health of Americans. Undoubtedly, if laws contain ambiguity, no any agreement will be achieved. That’s why new laws should be elaborated and existing laws should be altered.
The FDA believes that state regulators will coact with it in order to prevent producing and shipping contaminated medications.

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