FDA: ambiguity causes problems in regulation linked with pharmacies

The fungal meningitis outbreak which began in September 2012 had serious impact on America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and given to numerous persons. As a result, over 400 patients sickened with fungal meningitis in more than 20 states. 39 persons contaminated with this disease died. 14 deaths occurred in Tennessee.
It became obvious that it needed to do something for prevention of such cases. Contamination must not take place in future. The FDA had to meet with representatives of all states for discussion of this situation. Thus, recently a conference took place in order to prevent occurring contamination in the future.
It was affirmed during the meeting that new laws on compounding centers should be implemented.
Representatives of certain states claimed that they did proper job in their states and no any individual experienced troubles connected with contamination. Furthermore, they underlined with criticism that they didn’t know what occurred in other states.
As for the FDA, its authority over such situations is not established properly. Federal court cases that were during past years depressed the authority of the FDA evidentially. Furthermore, several laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, proposed to improve the situation through the following changes:
- to improve training of state regulators;
- to induce sharing information between the FDA and states;
- to remove ambiguity from laws.

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