FDA tries to strengthen its authority

The fungal meningitis outbreak which began in September last year had great impact on America. Contaminated injectable steroids were manufactured by the New England Compounding Center (located in Massachusetts) and administered by numerous persons. As a result, more than 400 patients sickened with fungal meningitis in over 20 states. 39 persons contaminated with this illness died. 14 deaths happened in Tennessee.
It became obvious 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 for discussion of this problem. Thus, lately a conference took place in order to discuss ways related to prevention of contamination in the future.
It was underlined during the conference that new rules on compounding centers should be elaborated.
Representatives of several states affirmed that they did appropriate job in their states and no any individual experienced troubles related to contamination. Moreover, they specified with criticism that they were not aware of 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, several rules 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 eradicate ambiguity from laws.

These items seem to be prudent. Such changes must help to promote improving public health of Americans. It goes without saying that if laws contain ambiguity, no any agreement will be achieved. That’s why new laws should be elaborated and existing rules should be modified.
The FDA believes that state regulators will work together with it in order to prevent manufacturing and shipping contaminated drugs.