If There Is a Shutdown (and We Still Hope There Won't Be) ...

FDA provides services that are core functions of government. And when FDA is unable to perform them (as in a shutdown), there is no one 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 and that consumers, patients and industries will 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, hopefully sooner than later.The question remains: how much damage will FDA and the public incur if there is a shutdown? Based on some e-mails I have received, there is a lot of concern about this and the media is likely to fan the flames of anxiety. 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.We know that product review programs that are partly paid by user fees will be staffed, but won’t be fully-staffed because taxpayer funding will not be available. Based on past shutdowns, 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 continued (or fully continued or not continued) during a shutdown.

The degree of damage to FDA depends a lot on how long a shutdown lasts and how effective the agency is in allocating resources to urgent and emergency tasks, both during a shutdown and immediately after. A short government shutdown will have consequences, but few are likely to be visible. The amount of time the agency will need to catch-up is probably longer than people realize, especially in offices that have vacancies and are already under heavy workload pressures. If the government is shut for a week, it may take several weeks (in some cases, longer) for the backlog to be worked down.We do not think a shutdown will extend beyond the coming week (five missed days), but there is no doubt that a longer shutdown will have a proportionally greater impact on the agency. If there is a shutdown (and we still hope there won’t be), then next week’s column will reflect what has been learned in the interim and take a deeper dive on the consequences for the agency.

Editorial note: The Analysis and Commentary section is written by Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA.