The Woman in Charge: Margaret Hamburg | The Politic:
". . . The Politic: Let’s move on to the recent meningitis outbreak. Was the FDA in this case supposed to have prevented the outbreak, or was the role of the FDA more in the response portion?
Sadly, the current regulatory framework for these so-called compounding pharmacies is inadequate and ambiguous as to the state role and the federal role, and we need to address that concern. I hope we can work with Congress to craft new legislation that will strengthen and clarify existing law. Within the existing legal framework, we are in a much more reactive posture rather than a preventive one.
As a public health official and the head of the FDA, I would really like to be able to see a system that could help us prevent this type of tragedy going forward. As we've seen the industry and healthcare system evolve, I think what has always been a concern about a lack of clarity between state and federal responsibilities has gotten more pronounced and more dangerous. More and more health care systems are relying on sort of hybrid compounding pharmacy/manufacturer in order to produce products they need. These facilities are in a gray area in between state and FDA regulations. . . . "
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