The fungal meningitis outbreak that began in September last year had serious influence on America. Contaminated injectable steroids were manufactured by the New England Compounding Center (based in Massachusetts) and introduced by numerous persons. As a result, more than 400 persons were contaminated with fungal meningitis in over 20 states. 39 persons sickened with this disease died. 14 deaths happened in Tennessee.
It became obvious that it was necessary to do something in order to prevent such situations. Contamination must not occur in future. The FDA had to meet with representatives of all states in order to discuss this situation. Thus, recently a conference took place in order to discuss ways related to prevention of contamination in the future.
It was specified during the conference that new rules on compounding pharmacies should be elaborated.
Representatives of certain states specified that they did suitable job in their states and no any person experienced problems connected with contamination. Moreover, they noted with criticism that they were not aware of what happened in other states.
As for the FDA, its authority over such situations is limited. Federal court cases that were during past years weakened the authority of the FDA substantially. In addition to these problems, several rules seem to be unclear.
Margaret Hamburg, the FDA Commissioner, expressed the proposal to improve the situation through the following modifications:
- to control training of state regulators;
- to promote sharing information between the FDA and states;
- to get rid of ambiguity in rules.
These points seem to be fair. Such changes must help to promote improving public health of Americans. Of course, if rules contain ambiguity, no any agreement will be achieved. That’s why new rules should be elaborated and existing laws should be modified.
The FDA hopes that state regulators will cooperate with it in order to prevent producing and shipping contaminated medications.
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