Another Week Down and Two to Go

Republican and Democratic leadership -- in both the House and Senate -- know exactly what outcome they want: a 10-week continuing resolution that will cover federal spending from October 1 until about December 11. All these leaders see a government shutdown as politically counter-productive and a waste of government time and resources.However, none of the leaders is in a position to assure the desired outcome. So, it is likely to be a tense 12 days until there is resolution (CR) or dissolution (shut-down). And then, if there is a CR, there is still the risk of yet another deadlock when the CR expires.While some scenarios are worse than others for FDA, any uncertainty is bad for the agency. I am sure that the Office of Management and Budget (OMB) and the Office of Personnel Management (OPM) have dusted off their shut-down plans from 2 years ago. Policies and priorities -- as well as their interpretation -- may have changed in that time, requiring a full review.I suspect that federal departments, such as HHS, have begun interpreting OMB and OPM guidance and applying it to situations within the Department. If no continuing resolution has passed by Monday, September 28 or Tuesday, September 29, there will probably be a public release of shutdown plans. This may come sooner to lessen confusion. Through all of this, FDA will have been actively figuring out how the rules will apply to them. Travel will be cancelled on October 1 and those away from their home base directed to return, whether their trip is complete or not.A shutdown is, of course a waste, not to mention distracting for FDA and all federal agencies. Because of user fees, FDA will have more individuals at work than most agencies. But even that activity is limited to work on which fees were paid pre-September 30. No new fees are collected. Worst of all, the disruption takes a toll even after FDA funding is restored -- the backlog of work takes time to erase. This will be particularly acute in food safety, where almost no one will be allowed to work if there is a shutdown.The shutdown is the worst case, one that we don’t think will occur (even while it can’t be ruled out fully). However, the uncertainty of waiting for CR vs. shutdown means that hiring will be delayed and new initiatives shuttled aside. A continuing resolution comes with its own restrictions, most notably that no new programs can be started. It literally forces an agency to stay within the boundaries of the previous year.This “no new programs” rule can be uneven in its application. We believe that FSMA work can continue under a CR, even if it involves new regulatory areas that saw little or no work in FY 15. On the other hand, FDA leadership will find it hard to start any projects unless precedent can be found in work that occurred in FY 15.Let us all hope for a more upbeat column next Friday, when there will be only 5 days left.Note: This week’s Analysis and Commentary was written by Steven Grossman, the deputy executive director of the Alliance for a Stronger FDA.