After BCA … What Are the Next Steps?
The FY 11 appropriations process took many extra months because of Congressional disagreement over how much to spend. That won’t happen again. The newly-passed Budget Control Act of 2011 (BCA) provides exactly $1.043 trillion to the appropriations committees to spend in FY 12. This spending level provides some relief (hopefully, for FDA, as well as other public health programs) from the House FY 12 budget resolution (the Ryan budget), which envisioned a $37 billion cut in non-security spending below FY 11 levels.
Under the House resolution, subcommittee spending limits (302(b) allocations) were so low that they required major cuts, even in vital programs. For example, the House FY 12 Agriculture/FDA appropriations bill would cut FDA by $285 million below FY 11 (–11.5%) and $572 million below the President’s FY 12 budget request (–21%).
The BCA’s $1.043 trillion limitation allots $359 billion for non-security spending. This is almost as much as the FY 11 level of $361 billion. Compared to the House FY 12 budget resolution, it is about $35 billion more.
We do not yet know how the House will handle this, since some of their appropriations bills have advanced (such as Ag/FDA), while others have not been marked up yet. We assume that the appropriations committee will re-set subcommittee 302(b) spending ceilings at some point. We doubt they would actually recall the Ag/FDA appropriations bill and re-do it, but rather a higher spending ceiling for the subcommittee would be a basis for House and Senate discussions on a final bill.
On the Senate side, where no budget resolution had been adopted, the BCA’s aggregate spending ceiling for FY 12 allows the appropriations committees to move forward with their work. Based on the $1.043 trillion limitation, preliminary Senate 302(b) subcommittee allocations have been made by the committee and discussed with appropriations subcommittee staffs. However, the allocations will not be finalized or public until after the committee formally adopts them when they next meet in early September.
Nonetheless, this provides a framework for Senate appropriations committee staff to continue to work during August and to be ready for September mark-ups. It is also possible that the Senate appropriations committee could adopt/announce 302(b) allocations in early September and immediately start marking-up bills. Since the Agriculture/FDA appropriations bill has already passed the House, there is a chance that it might be one of the first to be considered in the Senate.
Beyond this information, it is impossible to say where FDA or any other federal program stands for FY 12. Many Alliance members also receive information on either NIH or USDA appropriations and I doubt that there is anything more specific being discussed with regard to those agencies.
The Alliance’s next steps haven’t changed: we have been active in presenting the Senate with reasons why FDA needs an increased level of funding in FY 12. And we have been working to show the House that a higher FDA number from the Senate would be justified and should be accepted. As described in this week’s Advocacy at a Glance, we are involved in grassroots advocacy in August and have plans for an advocacy advertising campaign in Capitol Hill media, probably in September.
The Alliance’s position hasn’t changed either. Consistent with the President’s budget request, we believe FDA needs an increase of $287 million above FY 11. This reflects four ways in which the demands on FDA will increase significantly in FY 12:
- Globalization (for example, expand and upgrade overseas offices and import systems, more aggressive enforcement, initiative on medical product import safety)
- New responsibilities from Congress (for example, Food Safety Modernization Act, creation of a biosimilars pathway, medical countermeasures initiative)
- Complexity of science (for example, increasing scientific sophistication of medical products, personalized medicine, nanotechnology)
- Growth in the size and complexity of regulated industries (for example, companies import FDA-regulated products and ingredients from roughly 200 countries, using 825,000 importers, through over 300 U.S. ports–of-entry).
FDA’s responsibilities are not going to shrink just because federal spending is being reduced. We hope Congress sees, as we do, that FDA is not optional. It is part of what society needs to function.
Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.