FDA Supplier Shutdown and Cancer Drug shortages

An article in the Wall Street Journal (Dec 8, 2011) describes overdue preventive maintenance, quality issues (such as urine in a can in the storage area) not invetsigated enough and excessive defects in some products.  The result – the Bedford, Ohio plant of Ben Venue, a division of Boehriner Ingelheim and a supplier to Johnson & Johnson. The consequence – a shortage of a drug used against ovarian cancer – Doxil.  New patients are not being signed up and existing requirements met by allocation of existing supplies.  Given the different responses of European vs US drug regulatory authorities, with European authorities not recalling Doxil, how should the global supply chain react ? Should J&J be held responsible for appropriate in stock levels and if so, what should that level be targeted to be ? Should the FDA anticipate supply chain impact before shutting down the plant ?

About aviyer2010

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

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