pharmafileMay 17, 2017
Scott Gottlieb has wasted no time since his appointment to the role of FDA Commissioner last week. As one of his first acts in his new position, he has called for a reorganisation of its 4,000 inspection staff within the organisation which will see them working in one of six focused areas, as opposed to the broad approach which was taken previously.
The six focus areas include pharmaceuticals, medical devices, tobacco, food, biologics and research. Until this point, staff attentions were devoted to activity within their region, rather than product area, with 20 district offices reporting to five region heads.
As a result, the FDA’s 13 nationwide labs will each focus specifically on one of these new areas, while those working on imported goods will continue to oversee all products regardless of area.
Gottlieb noted that the move "will make our field programmes more modern and responsive to today’s threats and challenges, while making sure that we are taking a risk-based and science-based approach to our work. We need to make sure that we are achieving the greatest degree of consumer protection with the resources that we have."
It is thought that the effort will help with the implementation of Obama’s Food Safety Modernization Act, signed in 2011. Additionally, the restructure does not result in the loss of any staff.
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