When Congress was considering the 21st Century Cures legislation (signed into law by the President in December 2016), they were acutely aware that the new Act would create a number of requirements and program initiatives that were not paid for in the FDA’s base appropriation. The Senate HELP and House Energy and Commerce Committees were willing to pay for those additional costs through a reduction in unrelated mandatory spending under the control of the two committees. This met with understandable objections from the appropriations committees that it undercut their jurisdiction over FDA funding. This disagreement almost sank the legislation.Instead, the legislation created a hybrid pot of money -- the FDA Innovation Account -- that is neither budget authority (BA) appropriations nor user fees. On the one hand, savings from the cuts in mandatory spending can be used to fund specific provisions of the 21st Century Cures Act. On the other hand, the money would have to be included in an appropriation bill before it could be transferred to agency. The glue that made the deal work: while the transfer to the agency was not automatic, the inclusion of the monies in an appropriations bill was not to count against discretionary budget ceilings. So, appropriations committees were required to act, but it didn’t force them to weigh one use of funds for FDA against another.
Over a 9-year period, the FDA Innovation Account will receive $500 million, starting with $20 million in FY 17 (the first year). In FY 18, the amount was $60 million, and both House and Senate committees signed off on $70 million for Cures programming in FY 19. Click here to review the allocation by year. The funds will be set aside solely for FDA’s use to carry out Cures-generated responsibilitiesThe unique status of the Cures funding created something of a dilemma for the Alliance. Naturally, we are advocates for full funding. However, we don’t want appropriators to see narrowly-focused Cures money as addressing the broad array of new FDA responsibilities. If the agency needs more funding, it must occur through BA, not Cures monies. Our “ask” has been: the amount of increased and needed BA (taxpayer) funding “plus the separate $70 million from the Innovation Account to pay for Cures activities.” As a message, it was precise, but rather clunky.So, we were relieved when the President’s budget request was released, as it treated the Cures money as completely separate from BA funding. Once the House and Senate Ag/FDA appropriations subcommittees followed suit, we were able return to a full-time focus on advocating for increased BA funding and not divide our attention to cover Cures.We think this bodes well for future years. Now that it is accepted by all affected parties that Cures needs to be handled separately from consideration of BA appropriations, we expect appropriators to see this as a win-win. They get to approve vital FDA monies, but it doesn’t count against their budget ceilings.
Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.