User Fees for Generic Drugs - What are the Issues?


On August 9, 2010, the Food and Drug Administration (“FDA”) published a notice announcing a public meeting to be held September 17, 2010, “to gather stakeholder input on the development of a generic drug user fee program.” See 75 Fed. Reg. 47,820-21. FDA also requested submission of written comments on issues relating to assessment of user fees for generic drugs, which can be submitted by no later than October 17, 2010.

While FDA acknowledged most “[n]ew legislation would be required” for it to establish and collect user fees, the Obama Administration has already included generic drug user fees in its fiscal 2011 budget. So the possibility for assessment of user fees for generic drugs seems to be greater than in the past, as it is the only other major type of medical product that is subject to an FDA approval process for which user fees are not currently assessed.

FDA has identified the issues as follows...

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