User Fee Triggers Require Care In Unfriendly Budget Environment, Ventimiglia Says
Trigger changes could feed argument that user fees are a tax on industry.
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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.
Administration’s proposed fiscal year 2013 spending plan includes $4.5 billion for FDA, with $2 billion or 44% provided by various user fees.
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.