Thu, Jun-11-15, 03:19
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Plan: P:E/DDF
Stats: 225/150/169
BF:45%/28%/25%
Progress: 134%
Location: NC
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I linked another article in the other thread, but FDA funding follows the rule: "if you pay, you can play"
Quote:
Background
The bill, the FDA Safety Over Sequestration (FDA SOS) Act would specifically exempt FDA's user fees from the effects of future budget sequestration.
The user fees, which come from the pharmaceutical and medical device industries, are meant to help fund FDA's regulatory activities, and have been a key source of the agency's funding since they were first introduced in the Prescription Drug User Fee Act (PDUFA) of 1992.
The fees, which are charged for product applications, facility inspections and manufacturer registrations, are supposed to support FDA's hiring of new regulatory staff. In return, FDA has pledged to review (though not necessarily approve) products more quickly.
FDA has become increasingly dependent on user fees in recent years. Since 1992, when FDA only relied on user fee funding for new pharmaceutical product reviews, it has enacted new user fee programs for medical devices, animal drugs, generic pharmaceuticals, biosimilars, generic animal drugs and its tobacco programs.
If FDA's proposed 2015 budget is enacted, it would receive just shy of 42% of its total funding from user fees—$1.855 billion of its $4.44 billion proposed budget.
- See more at: http://www.raps.org/Regulatory-Focu...get-Cuts/#.dpuf
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