Senate Committee Suggests FY16 User Fees Harmonized With House Version

In a document released last week, the Senate Appropriations Committee calls for fiscal year 2016 user fee amounts totaling nearly $1.2 billion for drugs and biologics — figures that are in line with those proposed by its counterpart in the House.

The proposed funds are part of a larger $148.3 billion measure that covers USDA programs and agriculture initiatives, as well as the FDA.

Under the proposal, prescription drug user fees would increase from $798 million to $826 million, generics user fees would grow from $312 million to $320 million and biosimilars and biologicals fees would be $21.5 million, up from $21 million. The figures in the Senate bill, S. 1800, are the same as the House version, H.R. 3049.

The Senate bill appropriates $1.36 billion for CDER, $345 million for CBER and $63.3 million for the National Center for Toxicological Research — amounts that are more or less unchanged from the current fiscal year. In the House bill, the CDER and CBER appropriations are comparable, but NCTR’s amount is significantly lower, at $59.2 million.

The Senate Appropriations Committee approved the bill, proposing $2.6 billion in discretionary funding for the FDA. Detailed information on the CDER, CBER and NCTR appropriations amounts and the breakdown of user fees were not immediately available.

Both bills now go to a floor vote in their respective chambers, after which lawmakers from both houses will meet in conference committee to hammer out any differences. No dates have been scheduled for the floor votes.

Read the bill here: www.fdanews.com/072015-senate-appropriations.pdf. — Jonathon Shacat