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User Fee Triggers Require Care In Unfriendly Budget Environment, Ventimiglia Says

Executive Summary

Trigger changes could feed argument that user fees are a tax on industry.

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Biosimilars, Generic Programs Leave Little Room For Other New FDA Drug Initiatives In FY ‘13

Proposed and existing user fees would fund 44% of the $4.5 billion FDA FY 2013 spending plan. User fees are projected at $20 million for biosimilars and $229 million for generic drugs.

FDA's Projected $20 Mil. In 2013 Biosimilar User Fees Translates Into 68 More Staffers

Administration’s proposed fiscal year 2013 spending plan includes $4.5 billion for FDA, with $2 billion or 44% provided by various user fees.

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

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.

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