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What We Know … And What We Don’t

June 22, 2015

When the President releases his budget and when the Congressional committees start voting on the bills, those are the times when appropriations analysts are expected to earn their keep. So, it is personally frustrating not to be able to provide a full description of the situation in the House, where the Ag/FDA subcommittee favorably reported an FY 16 funding bill.

We know some things, but we are also missing a number of pieces. Metaphorically, we are a few bricks short of the load needed to build a proper analysis. The missing pieces will be contained in the committee report, which usually is not circulated until full committee mark-up.

Why are we in this incomplete state of knowledge, which doesn’t seem to be the case for other programs in the agriculture funding bill or NIH? The reason is that few agencies have two major sources of revenue. FDA derives approximately $2.6 billion in budget authority (BA) appropriations (taxpayer funding) and $1.9 billion in user fees (industry funding). (Note that the user fee number is skewed by the nearly $600 million in tobacco user fees.)

Each pot of user fee monies is usually distributed to two or more centers, as well as the Office of Commissioner. User fees also help pay for rent and IT. In short, almost every program level number at FDA (except at CFSAN) is a mix of funds. The committee report (not yet available) allows us to separate BA funding from user fee funding and program-level totals. The bill and one-paragraph summary (both available now) do not.

What we know is this: FDA’s BA appropriation would be increased by $30 million. We believe this will take the agency from $2.590 billion to $2.620 billion. That is, at the same time, both a needed step forward and a disappointment, even given the severely restricted budget situation.

The bill summary also tells us that FSMA funding will increase by $41.5 million and medical product safety will increase $4.2 million. This is presumably BA money and creates a situation where there must be an offset if there is only a net overall $30 million BA increase. Possibilities include: cuts to centers and the Office of the Commissioner; administrative savings, perhaps from White Oak build-out monies that don’t need to be funded again; a reduction in rent costs and etc. We will know for sure when the committee report is released, but there is a chance that we will be able to find the answer to this sooner.

So, there you have it. The subcommittee has voted and we are reporting what we know or can project. If the full committee marks-up next week, then we will be able to say more in next week’s report. If not, it will likely be July before we have answers.

Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.

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