Some Shocks -- Some Pleasant; Some Less So

Having discussed Congress’ busy September agenda in depth, here and here, I didn’t expect there would be much news to write about this week. Sure, there would be updates on Congress’ initial progress, but I didn’t envision anything of consequence so quickly.Instead, Congress is most of the way (possibly by COB Friday, all the way) to a FY 18 Continuing Resolution keeping the government in operation from October 1 to December 8, 2017. Depending on your viewpoint, this can be seen as “crisis averted” or “kicking the can down the road.”With a CR in place, the FDA -- along with other government agencies -- should be able to operate smoothly for the 10 weeks starting October 1. However, even a short-term CR works to FDA disadvantage: long-term planning is disrupted, hiring with BA monies is risky, and new non-emergency projects (depending on how defined) may be delayed because they are not “continued” from FY 17.Further, the status quo is not being fully maintained under the CR. Rather than providing funding at the FY 17 level, the CR actually calls for spending at a level that is 0.6791 percent less. The reduction will cost FDA about $3 million in BA funding (rough estimate). This is an unpleasant surprise for an agency that can ill-afford to have its budget cut, even by a small amount. It is uncertain whether the reduction will be carried over into final appropriations bills.The impact of the CR on user fees is unknown at this time. We expect that this will be clarified within the next week or so; certainly well before the CR takes effect on October 1.Summing this all up, the CR serves a larger governmental function, but is not favorable to FDA and may raise questions that need to be addressed. One thing is certain: it would be better for the agency if the Ag/FDA appropriations bill -- either freestanding or as part of the “mega-bus” appropriations bill -- becomes law as soon as possible.Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.