FDA: ambiguity must be eradicated from rules on pharmacies

The fungal meningitis outbreak that began in September 2012 had evident influence upon America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and applied by many persons. As a result, over 400 patients were contaminated with fungal meningitis in over 20 states. 39 persons sickened with this disease died. 14 deaths happened in Tennessee.
It became evident that it needed to do anything for prevention of such situations. Contamination must not occur in future. The FDA had to meet with representatives of all states in order to discuss this problem. Thus, recently a meeting took place in order to find ways linked with prevention of contamination in the future.
It was underlined during the meeting that new rules on compounding centers should be elaborated.
Representatives of some states said that they did proper job in their states and no any person suffered from troubles related to contamination. Moreover, they noticed critically that they didn’t know what happened in other states.
When it comes to the FDA, its authority over such cases is not established properly. Federal court cases which were during past years cut the authority of the FDA essentially. Moreover, 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 dispose of ambiguity in laws.

These items seem to be reasonable. 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 laws should be implemented and existing laws should be modified.
The FDA believes that state regulators will coact with it in order to prevent manufacturing and shipping contaminated medicines.