Differential inspection of generic manufacturing facilities

An article in the Wall Street Journal (February 16, 2011, B1-3) describes the fact that FDA inspection of US pharmaceutical manufacturing facilities is usually once every two years but foreign plants are inspected less frequently, with 64 % of the foreign facilities never inspected.  Plant inspection is key because sales of generics require FDA approval of the plant’s manufacturing processes. Generic drug manufacturers are not charged user fees and thus wait over 2.5 years for approval, prevented them from reacting when patents run out. Should the FDA charge user fees and speed up inspection of plants both US based and global ? Will these fees increase patient costs or will it lower the costs because generic drugs will be available sooner rather than later ? Finally, given current inspection regimes, is there an incentive for domestic production of these generic drugs ?

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About aviyer2010

Professor
This entry was posted in Global Contexts, Operations Management, Supply Chain Issues and tagged , , , , , . Bookmark the permalink.

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