Is a Shutdown on the Horizon?

FDA provides services that are core functions of government. When FDA is unable to perform them (as in a shutdown), there is no other entity (public or private) that can pick up the slack. So, it seems particularly wrong that FDA is caught up in an unrelated partisan fight over border security and that consumers, patients, and industries could be short-changed. However, none of us are positioned to affect the outcome. We are dependent on Congressional leaders and the White House to get it resolved, preferably sooner than later.On a somewhat hopeful note, government shutdowns are threatened a lot more often than they occur. At this point (about 8 days out), shutdowns always seem to be inevitable because the two sides are far apart and discussions are either not occurring or seem fruitless. Nonetheless, a further continuing resolution or a deal on the items in dispute is more likely to occur than a shutdown. Also, a shutdown is more likely to be short than long ... although the Xmas/New Year’s week/swearing-in of a new Congress may complicate that.A number of Alliance members and the media have sent questions, hopefully these answers are responsive. Let Steven or Ladd know if you have additional issues that we can address.

• This will be different from prior shutdowns (and shutdown threats) because HHS is already funded. However, virtually all of FDA’s money, including user fees, comes through Ag/FDA appropriations, a bill that has not yet been enacted. That HHS is working (except FDA and the Indian Health Service) does not, as far as we can tell, help FDA.

• Next week, if a shutdown threat still exists, HHS will publish headcount numbers for each part of the department that is unfunded and the rationale for those who will be allowed to continue to work. A shutdown would not affect commissioned corps officers, who are scattered throughout the agency. Also unaffected would be individuals working in areas where their absence would constitute a threat to public health and safety or property. So, for example, emergency inspections would be staffed, but not routine ones. Security guards and public health lab workers will mostly be on the job, but not most individuals involved in the development of regulations or the conduct of administrative or policy work. In past shutdown threats, sometimes human protection at FDA has been narrowly interpreted and other times more broadly.

• User fee work can generally continue, including the personnel needed to perform those tasks. Our understanding is that the user fee exemption from the shutdown is task driven, not individual person driven. As a result, someone working on user fee tasks can’t work on other tasks just because they are in the office. See attached relating to user fees.

• Based on past shutdown planning, products on which user fees have already been paid (e.g. NDAs) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be fully continued (or partly continued or not continued) during a shutdown.

• We know that food safety will be particularly hard-hit, as will routine inspections. Certainly, medical product companies with near-term expectations — review meetings, initiating clinical trials, etc. — are faced with the possibility of slippage in their development timelines but the impact will be subject to decisions that may be driven by individuals situations as well as interpretation of whatever general directions are provided by HHS.

• Agency websites will not be updated during a shutdown. Portals may close. Personnel who routinely respond to important matters – like Food Facility Reregistration, which must be done by December 31 – will most likely not be available.

• As described above, there is a degree of variability in the FDA’s situation that will not be clear until there is December 2019 guidance from HHS. Nonetheless, past documents (here and here) are useful guides in assessing the likely impact of the possible shut-down at midnight on December 21.

We will keep you informed as the picture becomes clearer.Editorial note: The Analysis and Commentary Section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.