FDA’s authority was weakened

The fungal meningitis outbreak which began in September 2012 had serious impact upon America. Contaminated injectable steroids were produced by the New England Compounding Center (located in Massachusetts) and used by a lot of persons. As a result, over 400 individuals were contaminated with fungal meningitis in over 20 states. 39 persons contaminated with this illness died. 14 deaths were in Tennessee.
It became evident 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 underlined during the meeting that new laws on compounding pharmacies should be introduced.
Representatives of several states said that they did appropriate job in their states and no any individual suffered from problems connected with contamination. Moreover, they underlined critically that they didn’t know what happened in other states.
As for the FDA, its authority over such cases is not established well. Federal court cases which were during past years depressed the authority of the FDA significantly. Moreover, some laws 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 induce sharing information between the FDA and states;
- to eliminate ambiguity from rules.

These proposals seem to be rational. Such changes must help to promote improving public health of Americans. Of course, if laws contain ambiguity, no any agreement will be reached. That’s why new rules should be introduced and existing rules should be modified.
The FDA hopes that state regulators will collaborate with it in order to prevent manufacturing and shipping contaminated preparations.