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Generic Program Is Biggest Extra Item In Senate User Fee Reauthorization Bill

 
• By Nielsen Hobbs

US FDA would need additional appropriations to cover all activities contemplated in the legislation – and the bill appears to need a pay-for because it increases the deficit.

FDA entrance sign 2016

The US Congressional Budget Office (CBO) has concluded that FDA would need additional resources beyond user fees to carry out all the programs envisioned in the Senate's user fee reauthorization bill, with activities related to generic drugs accounting for much of them.

CBO's score estimates that, "assuming appropriation actions consistent with the bill," FDA would spend an additional $1.24 bil. over the next five years – $566 mil. of which...

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