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CRS report R44750 on FDA user fee programs
Congressional Research Service overview of the FDA's human medical product user fees.
- Dates
- 21 Nov 2017
Connections 1
author
- Congressional Research Service 21 Nov 2017 Primary record 1
Timeline 2 dates
- 21 Nov 2017 CRS report R44750 on FDA user fee programs
- 21 Nov 2017 Congressional Research Service authored CRS report R44750 on FDA user fee programs
Proof 1 source
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FDA Human Medical Product User Fee Programs: In Brief (R44750), Congressional Research Service, 21 Nov 2017.
Primary record
In FY2007, prescription drug user fees provided 56% of the PDUFA program total costs (appropriations provided 44%); in FY2016 (from the most recent financial report available), user fees covered 72% of PDUFA program total costs
Prior to the passage of GDUFA I, generic drug companies submitting ANDAs were not subject to user fees from FDA
In FY2013, the first year generic drug user fees were collected
Some critics of the current scope of the user fee programs are concerned that FDA's mission to protect public health may be compromised if reliance on these fees affects the impartiality of FDA's scientists.
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