So ... How Do We Help FDA Get a Fair Cut of the Extra $40 Billion?

After this week’s dramatic passage of a two-year budget deal and the election of Paul Ryan as House Speaker, what’s next? And what does it mean for FDA?With regard to the $40 billion in additional non-defense discretionary spending ($25 billion in FY 16 and $15 billion in FY 17), everybody assumes that the money has not been spent yet. This may seem like a truism, but nothing prevents this leadership-driven deal from having had an informal side agreement. They may have already divvied up the money, such as "$10 billion will go to infrastructure, $5 billion to VA, $5 billion to NIH and $5 billion to education.” There is no evidence that there was such a side-deal and it does seem unlikely.If not, then sometime soon (maybe next week), the chairs of the House and Senate appropriations committees will re-do the subcommittee spending allocations and give new spending targets to each. It is possible that the money will be allocated proportionally or that certain areas will be favored with a larger percent of the new money. It is also possible that a subcommittee could be given a spending ceiling in the House and a different one in the Senate.

Once the allocations are made, it becomes the responsibility of each subcommittee to revise its earlier, committee-passed appropriations bill. Programs may get the same amount as before. Others might get more. It is not out of the question that some programs will get less, based on some event that has occurred since the earlier mark-ups.We do not know whether the finished appropriations bills will move forward as stand-alone legislation or whether they will be rolled up into an omnibus. Most people think the latter. Either way, the deadline is December 11. We can’t imagine anyone in leadership wants to risk another continuing resolution. However, the budget deal does not prevent so-called policy riders that could tie up the appropriations process with partisan disagreements.Overall, the budget deal is the end-game that we have been hoping for. It puts the appropriations committees back in charge, to sort national priorities and allocate the additional funds to areas of greatest need. It gives FDA its only chance to receive further increases in FY 16 funding.We have already been working hard on this. We held an additional Hill Day -- in September -- designed to spread the message: if funds become available, FDA can use the resources, given its increasing responsibilities, globalization, and increasing scientific complexity. We’ve stayed in touch with appropriations staff. The Members who have spoken up for increased FDA funding have been thanked.

Together, we must now take the additional steps of reminding appropriators why FDA is important, as well as remind authorizers that they have a responsibility for delivering these messages, too. For those who know what to do, please get started. For those who need a little help, we will have a toolkit ready next week for distribution to Alliance members.

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