After many years of negotiations with the U.S. government, the generic drug industry has agreed to pay $299 million in annual fees to allow for inspections of foreign manufacturing plants every two years. 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 the New York Times. "FDA's entire generic drug program would be placed on a much more stable footing."
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. But, as the NYT notes, the FDA would need more than 13 years to inspect every foreign drug plant exporting to the U.S. And with scandals like tainted heparin popping up every so often, the FDA has faced mounting pressure to increase inspections, so these fees could definitely help.
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