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Questions and Answers About the FDA’s FY 15 Budget

April 4, 2014

Q: News articles are saying the House is likely to consider an FY 15 budget resolution. Given the Ryan-Murray budget deal sets caps on FY 15 discretionary spending, why would the House do a budget resolution?

A: Strictly speaking, we don’t need a budget resolution for FY 15. And any House effort is presumptively “dead on arrival” in the Senate.

However, the Ryan-Murray deal leaves a one-year/election year hole in Republican efforts to be seen as the party most committed to reducing the budget deficit … so it makes sense for them to stay active. A budget resolution might affirm their bona fides and create some votes that can be used against Democratic incumbents.

The immediate fear is that House Budget Committee Chairman Paul Ryan will use the budget resolution mark-up as a vehicle for breaking down the FY 15 division between defense and non-defense spending. That scenario would reprise the FY 14 House budget resolution, which attempted to move $40 billion from the non-defense spending cap to pay for defense increases.  Thus far, it is unclear whether the House will try to do this again in FY 15.

Independent of that, there is still plenty of room for the House to use an FY 15 budget resolution to push the envelope on entitlements and scoring methodologies in FY 15 and beyond … and to advocate for out-year (FY 16 and beyond) changes in discretionary spending. This suggests that any House effort is a long-term worry for us (2016 and beyond), but not a short-term concern (2015). However, there are a number of places (substantively and politically) where a budget resolution could impact domestic discretionary spending and become an immediate concern to us.

Q: FDA continues to push hard on how the President’s budget proposal allows program growth in FY 15. What is the problem with their analysis?

A:  Instead of an increase, the President’s FY 15 budget request will leave FDA programs with more responsibility and less money than they had in FY 14.

The Administration is claiming its request is a $358 million increase over FY 14, over 8%. However, when you subtract proposed (but not enacted) user fees and increases in tobacco user fees, a very different picture emerges. Specifically:

  • FDA’s food safety activities would gain $23 million in appropriated funding, but have about $15 million less from existing (current law) user fees than in FY 14.  The Administration has said that implementation of FSMA requires more than $200 million in additional funding. However, those monies would come from a proposed food user fee program that—regardless of merit or lack of merit—is not going to become law this year. Commissioner Hamburg admitted as much at the March 27, 2014 House hearing. Thus, in the food safety arena there is virtually no money provided against an acknowledged rapid increase in responsibilities.
  • FDA’s  medical products programs would receive no net increase in appropriations across an incredibly vast set of responsibilities that are growing as a result of program mandates and globalization. Even the Administration’s proposal for $25 million to implement regulation of pharmacy compounding is coming from other program activities, not new monies.

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

[The Alliance’s sitemaster apologizes for the delay in posting this material to the Alliance’s web site. This information was circulated to the Alliance membership on March 28, 2014]

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