Happier ... But Not Out of the Woods by Any Means

At a time when massive budget cuts are being discussed, FDA is a bit of an oddity. The President has actually proposed more resources for FDA, but only by a massive $800 million per year shift from taxpayer-supported BA appropriations to off-budget user fees. Neither the House Energy and Commerce Committee nor the Senate HELP committee showed any interest in the President’s approach. This week, the House Ag/FDA Appropriations Subcommittee delivered the same message by restoring the agency’s FY 17 BA funding level, appropriating $60 million in CURES monies and accepting user fee levels from the already-negotiated FDA-industry commitment letters.

The Alliance was pleased with the House action and we said so (see this media release). We believe FDA should be funded by a balanced mix of taxpayer dollars and user fees. The House subcommittee mark reaffirms this. Likewise, we feared that the President’s proposal could result in the agency's appropriation being cut by $500 million or more. The House subcommittee mark was our first sign that the appropriations committees don’t consider that a possibility.So, all of this is good news and reason to celebrate. However -- beyond the question of what the Senate will do -- we are very far from out of the woods on the FY 18 cycle.First,  FDA’s increasing responsibilities means the agency’s BA appropriation should grow each year. We have asked Congress for a BA appropriation of $2.84 billion, an $80 million increase over FY 17 (our CURES Act request is additional). Even that amount may not be enough to fully fund food safety activities and will definitely not cover new non-user fee activities contained in the pending FDARA legislation.  We hope to continue fruitful discussion with Congress about FDA’s expanding duties and the pressures on the agency to build and retain critical medical and scientific personnel.Second, a subcommittee mark-up is always subject to revision at full committee and on the floor. This year, the risk is much greater (and extends longer into the process) because a House budget resolution has not been adopted. Several House appropriations subcommittee have started marking bills up, without really knowing how much they will have to spend. It is in the realm of possibilities that the budget resolution will provide too little funding on the non-defense discretionary side and subcommittees that have marked up will have to re-look at what they have done.Third, the sequestration mechanism -- a way to reduce spending when Congress appropriates more that the budget ceiling -- leaves FDA and other agencies vulnerable to “across the board” cuts. Actually, there are two levels to this. We already know that the non-defense discretionary ceiling will, in effect, be lower in FY 18 than it was in FY 17.  Simply put, not every agency and program can get as much as they did in FY 17.  Further, the House budget committee is considering proposals that would further reduce the non-defense ceiling and would make even less money available to subcommittees.

For the coming holiday week, Ladd and I wish you lots of great family time, plenty of relaxation, and maybe a few productive moments along the way. The next "Friday Update" will be issued on July 14, but we are here to serve the Alliance throughout the intervening time.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.