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16 Aug 2011

U.S. Government & Generic Industry Reach Deal on User Fees

Not everyone has seen user fees as a good idea, with critics raising questions about the idea of the FDA receiving funding from the very companies it's regulating.

The generic drug industry has agreed to pay $299 million in annual fees to allow for inspections of foreign manufacturing plants every two years after many years of negotiations with the U.S. government.


Experts are predicting Congress will bless the deal, which Hovione CEO Guy Villax calls "epoch-making."


User fees have long been a contentious issue. FDA Commissioner Margaret Hamburg has called them necessary because they could help in alleviating the backlog of drug applications.


"If a program along the lines of what the parties are working on is enacted by Congress, it would represent a real breakthrough," said FDA Commissioner Margaret Hamburg, as quoted by t

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