Fuzzy Math and New Score (but Not on Goal)

The CBO score on the Senate committee-passed FDARA bill is probably not going to matter. I have been told that the Manager’s Amendment that will be offered on the floor (including updated technical assistance from FDA) will be quite different from the committee version; at least enough so that the bill on the floor and the CBO report will not be aligned. Nonetheless, there are several important lessons to be learned from the CBO report about new programs and requirements that will need BA funding and cannot be funded from user fees.First, budget scoring rules are often arcane and will tend to overstate the BA monies that will be needed. For example, BA programs that are expiring September 30 and being reauthorized for October 1 are treated as entirely new costs, even though they were funded in FY 17 and are part of FDA’s base appropriation. It also appears that increases in the authorized level of existing discretionary programs are being treated as new costs, even though the additional dollars might not be appropriated.Second, it would appear that at least some of the items identified as “new” and needing BA funding are likely to be carried out largely or entirely by staff that is already in place at FDA. In some, perhaps many, cases, the cost of the “new” activity is already in the existing FDA appropriations base and does not require additional hires.Third, the boundary between what can and cannot be paid for with user fees is well-defined, but not in every instance. CBO identified some programs and requirements as needing BA funding that I am told are similar to, or extensions of, activities now funded by user fees.Fourth, some distinction should be made between “need to have” funding and “nice to have” BA funding. Where the FDA is required to act (with non-user fee funds), then these become “unfunded mandates” if the appropriations committees don’t provide funding. However the CBO score also involves things that Congress thinks are valuable, but which do not compel FDA to act. These are “nice to have,” but the agency can choose not to act in the absence of resources.The Alliance is a zealous advocate for all of the funding that FDA needs to fulfill its responsibilities and carry out its mission. However, realistically, we cannot tell appropriators that just because of FDARA the agency needs an additional $250 million per year/$1.2 billion over 5 years in BA funding. It’s just not credible, largely because we know it’s unlikely to be true. However, on further examination, we see that there are a number of reasons why the actual amount of new money is likely to be substantially overstated by CBO. Further, not all of the money is of equal urgency.Ideally, we would like to be able to say to appropriators: here is the amount of new money that is absolutely required and therefore urgent … and here is the amount needed for additional items that provide substantial public benefit but are not mandates. We can say for sure: FY 18 will not be a year in which inflated requests and fuzzy math will go unchallenged.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA