Appropriations For CDER, CBER Would Grow In FY 2012 Under House Bill That Keeps FDA Flat

Funding bill prepared for mark-up on May 24 relies on growth in user fees and reductions elsewhere in the FDA budget.

Funding for FDA's drug and biologics programs would increase in fiscal year 2012 compared to fiscal 2011 under a draft House bill that essentially keeps overall agency approprations at the same level in both years.

Spending at the Center for Drug Evaluation and Research would grow to $1.03 billion, up from $957 million in FY 11, according to the legislation, which was unveiled May 23 in preparation for a May 24 markup during which Agriculture/FDA Appropriations Subcommittee members will vote on the measure.

The budget for the Center for Biologics Evaluation and Research would increase to $327.7 million, up from $325.6 million.

User fees will provide an ever-growing portion of money for the two centers, which receive the bulk of PDUFA fees. While CDER and CBER would increase by a combined $76 million, the prescription drug user fees will increase by $189 million, up from $667 million in FY '11 to $856 million in FY '12.

Overall, user fees will grow from $1.204 billion in FY '11 to $1.49 billion in FY '12. Instead of increasing funding for FDA, however, Republican budget cutters propose to use the fees to keep overall FDA appropriations at $3.654 billion, down $1.5 million from $3.656 billion in FY '11. This would enable them to cut the agency's budget authority, or direct federal spending, by about $286 million.

The proposed cuts in budget authority are not as hefty as those proposed by House Republicans for FY '11 (Also see "FDA User Fees Soften Sting Of Second Round Of House Budget Cutting For 2011" - Pink Sheet, 14 Feb, 2011.).

Those were turned into an increase for the agency after negotiations with the Senate (Also see "FDA Budget To Rise By $418 Million In FY 11 As Congress Decides To Cut Spending Elsewhere" - Pink Sheet, 12 Apr, 2011.).

-Cathy Dombrowski ([email protected] )