Tuesday, April 04, 2006

When is a generic not a generic - the US FTC to investigate

US pharmaceutical legislation grants an exclusivity period to the first generic competitor of a branded drug. An FTC enquiry is to investigate the impact of pharma companies taking advantage of their ability to themselves launch unbranded drugs (authorized generics) during this period. There is concern that this could stifle the competition hoped to be generated by the exclusivity available to the first generic manufacturer.

A reminder that there are always wheels within wheels of each particular situation. General calls for manufacture of generics, or in other fields parallel importing or exporting, will not necessarily resolve the problem. Step by step analysis, and realistic forward thinking, are required.

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