New rules will be implemented for prevention of contamination

The fungal meningitis outbreak that started in September 2012 had obvious influence on America. Contaminated injectable steroids were produced by the New England Compounding Center (based in Massachusetts) and applied by many persons. As a result, more than 400 patients were contaminated with fungal meningitis in over 20 states. 39 individuals contaminated with this disease died. 14 deaths occurred in Tennessee.
It became obvious that it was necessary to do something 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 problem. So, recently a conference took place in order to find ways linked with prevention of contamination in the future.
It was noted during the meeting that new rules on compounding pharmacies should be elaborated.
Representatives of some states specified that they did appropriate job in their states and no any individual experienced troubles related to contamination. Moreover, they noted with criticism that they didn’t know what happened in other states.
As for the FDA, its authority over such cases is not established properly. Federal court cases that were during past years cut the authority of the FDA substantially. Furthermore, certain rules 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 induce sharing information between the FDA and states;
- to dispose of ambiguity in laws.

These points seem to be prudent. Such changes will probably help to induce improving public health of Americans. It goes without saying that if laws contain ambiguity, no any agreement will be reached. That’s why new laws should be introduced and existing rules should be altered.
The FDA hopes that state regulators will work together with it in order to prevent producing and shipping contaminated medicines.