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Biosimilar, Generic and Rx User Fees Rely On Different Adjusters For Needed Appropriations

 
• By Derrick Gingery

The biosimilar and generic drug user fees use different CPI measures, meaning they could increase the appropriations needed to allow user fee collection at different rates.

The required appropriations for the prescription drug, generic and biosimilar user fees will increase based on different calculations, potentially creating a headache for FDA and congressional appropriators.

Congress also may have to increase the amount appropriated for the generic drugs program to a level recommended in 2010 just to ensure fees can be collected, according to draft legislation outlining

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