Something Less Than an Ideal Scenario for FY 15 Budget

As more fully described in last week’s Analysis and Commentary, the House and Senate positions share a common base, but are quite different in many of the details. This chart makes it easy to compare the positions of each against the Administration request and prior year funding levels.Both House and Senate want to fund CFSAN at $903 million and assure that food safety receives $25 million in new monies. While that was all the BA appropriations that FDA asked for, their budget request made clear that it will take additional funds to implement FSMA. Congress has visibly, and somewhat angrily, disagreed with the Administration proposal to derive those funds from user fees. Nothing can happen in that regard without the authorizing committees (House Energy and Commerce, Senate HELP) first passing a law creating the user fee, then appropriators would have to decide whether to provide the go-ahead through the appropriations process. None of the four required committees has shown any interest.On the medical product side, the House and the Senate have different funding levels for CDER, CBER, CDRH and NCTR. All but CDER face the possibility of receiving less money in FY 15 than they did in FY 14. Implementing a new pharmacy compounding program -- an Administration priority for a law passed by Congress just last year -- would receive only half the requested monies in the House bill. The level for the pharmacy compounding program in the Senate bill, with its overall higher spending levels, is unclear.Apart from the all-important funding levels for each center and program at FDA, both House and Senate decided to ask for greater accountability in FY 15 and thereafter. For example, the House expressed concern about “the financial management of FDA’s user fee programs.” Additional monthly reporting will be required.The Senate expressed concern that “oversight of FDA has not kept pace with the growth in the agency’s regulatory authority or funding.” To address this, they propose that the HHS Office of Inspector General be given $1.5 million to fund FDA oversight. The Senate also asked for additional details on how FDA has spent the FY 13 sequestered user fees that were returned to the agency in FY 14. Their concerns specifically identify regulatory science activities as an area in which they would like greater accountability and assurance that funds are being spent.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA