FDA Budget Proposal Shifts More Toward User Fees Reliance
This article was originally published in The Tan Sheet
User fees make up the bulk of FDA’s human drug spending under President Obama’s fiscal 2014 budget proposal, a trend fueled by new user fee programs and cuts to taxpayer funding.
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FDA’s $4.7 billion fiscal 2014 budget request proposes new fees including $58.9 million from food establishment registrations and inspections, $19.1 million from cosmetics firms and $15.04 million from medical product reinspections.
Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.
HELP Chairman Harkin and ranking member Enzi say potential riders added to the FDA user fee bill could slow down passage and add more work for agency staff. The senators’ concern follows House appropriators’ doubts as obstacles to approval for new food safety user fees.