And Now for FY 17 -- Starting January 12

Closure of the FY 16 appropriations process, along with a 5% funding increase, allows us renewed confidence in FDA’s ability to achieve its goals in 2016. FDA can now proceed with its work plans for the year, knowing that it has urgent food safety funding and some new dollars for initiatives on the medical product side. In accomplishing its goals, FDA would have been better off if it had its appropriation on October 1; however, the appropriations drama could well have spilled into next year, to the further detriment of the agency.

This timing of the omnibus appropriations bill -- just before the holidays -- means that we get a short rest from the marathon 12-month Congressional appropriations cycle. The President’s state-of-the-union address -- on January 12, only 3½ weeks away -- is the starter’s gun for the next race.Some think that the FY 17 appropriations will be simple. The thinking goes: with a Presidential election looming, the appropriations process will be desultory until September, then quickly morph into a continuing resolution (6 months?) that will give a new administration some opportunity to influence spending in the second half of fiscal year 2017. Since a 6-month CR is rarely a good outcome for FDA, we have to wish for other scenarios.An “immediately-in-January” consideration is that the President’s budget request is going to be a muddle. The budget will have been put together using FY 15 as the base for FY 17, rather than the FY 16 final that hasn’t existed until this week. Here is how that becomes a detriment for FDA: the Administration might well have renewed its FY 16 request for a $147 million increase over FY 15. However, $133 million of that is already accounted for in the FY 16 increase. Thus, the Administration “ask” translates into a mere $14 million increase. Eventually, this will get sorted out with a revised budget request, but that may take time and will sow confusion.

Meantime, the Appropriations chairs and House and Senate leadership have all committed to a regular appropriations cycle, with bills emerging from committee, being voted upon on the floor, and eventually resolved in a House-Senate conference. An omnibus bill may be better than a continuing resolution, but it is not as good as having 12 individual appropriations bills considered and adopted. This should translate into some serious efforts to move bills and not wait for a September CR.

We don’t yet know what type of year 2016 will be. The constant is: FDA will need our help making the case for more resources. The Alliance and you, our members, need to be ready for the battle.Wishing everyone a restful holiday season and a happy new year.

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