FDA wants to achieve clearness in rules

The fungal meningitis outbreak that started in September last year 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 persons were contaminated with fungal meningitis in more than 20 states. 39 persons sickened with this illness died. 14 deaths were in Tennessee.
It became evident 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 problem. Thus, lately a meeting took place in order to find ways linked with prevention of contamination in the future.
It was underlined during the conference that new laws on compounding centers should be established.
Representatives of certain states claimed that they did suitable job in their states and no any person experienced troubles linked with contamination. Moreover, they underlined with criticism that they were not aware of what happened in other states.
When it comes to 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 significantly. In addition to these problems, several laws seem to be unclear.
Margaret Hamburg, the FDA Commissioner, expressed the proposal to improve the situation through the following changes:
- to improve training of state regulators;
- to promote sharing information between the FDA and states;
- to eradicate ambiguity from laws.

These items seem to be fair. Such changes will probably help to promote improving public health of Americans. It goes without saying that if rules 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 coact with it in order to prevent manufacturing and shipping contaminated drugs.