The fungal meningitis outbreak which began in September 2012 had evident impact on America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and administered by a lot of persons. As a result, more than 400 persons sickened with fungal meningitis in more than 20 states. 39 individuals sickened with this illness died. 14 deaths happened in Tennessee.
It became obvious that it was necessary to do something 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, recently a conference took place in order to prevent occurring contamination in the future.
It was affirmed during the conference that new laws on compounding centers should be implemented.
Representatives of several states claimed that they did good job in their states and no any person experienced troubles linked with contamination. Moreover, they specified critically that they were not aware of what happened in other states.
As for the FDA, its authority over such situations is not established properly. Federal court cases that 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 promote sharing information between the FDA and states;
- to escape from ambiguity in rules.
These items seem to be prudent. Such changes will probably help to induce improving public health of Americans. Of course, if rules contain ambiguity, no any agreement will be reached. That’s why new rules should be elaborated and existing laws should be modified.
The FDA believes that state regulators will work together with it in order to prevent producing and shipping contaminated preparations.