What Happens at FDA in a Shutdown?
Please note that this Analysis and Commentary, issued by the Alliance on Friday, September 27, has been superceded by new information obtained by the Alliance. Please click here to see the most recent information.
We are inclined to agree with political analyst Stuart Rothenberg that today’s political environment dictates that deadlocks are rarely resolved before the final hours. It is also hard to see that anybody benefits — substantively or politically — by allowing a shutdown, even for a couple of days. But that actually begs the question “what happens to FDA in a shutdown?” The threat of a shutdown will still be there when the short-term CR expires, whether that is a few days, a few weeks or November 15. If the debate over ACA funding is not resolved as part of the debt limit fight, then it will come back to the CR appropriations cycle.
In trying to provide a sense of what could happen to FDA if there is a shut down, we know that past rules are generally still in effect, but are subject to re-interpretation or revision. So, we rely heavily on the HHS Shutdown Contingency plan from 2011 (available here) — while qualifying everything with the disclaimer that it could be different this time. During the frequently discussed 1995-1996 shutdowns, FDA was not affected because the Agriculture Appropriations bill had already been enacted.
In 2011, the potential shut down was in the middle of the fiscal year, so some of the impacts might be greater or smaller for a beginning of the year shut down. However, in 2011:
- 11,711 of the then 13,673 employees were to be furloughed. That is 86% of employees (including those paid from appropriations and those paid from user fees).
- One of the few functions of FDA that would continue is to “review imports offered for entry into the U.S. and make admissibility.”
- The document also highlights the critical nature of FDA, even in comparison to the other very important HHS agencies. FDA had more than 50% of the HHS employees not to be furloughed because of “human safety.” That number was 1,250 people. CDC had the bulk of the rest.
One anomaly is the statement that carryover user fees can continue to support employees (see “staff performing activities without funding issues” on page 4 of the HHS Shutdown Contingency plan). However, on the first page of the chart (at the back of the memo), only 330 FTEs at FDA are attributed to this rationale. This is about 10% of FDA’s FTEs paid for by the various user fees, so clearly user fee funds do not automatically bypass the lack of appropriations. We are seeking explanation from government sources about how to understand this discrepancy.
Finally, we have received numerous inquiries about what happens to advisory committees, PDUFA deadlines, and various other product-critical, non-safety activities. Virtually all of this would come to a halt in a shutdown. Depending on the level of user fees allowed to be spent (see prior paragraph), then medical product review activities might continue to some extent. FDA would, presumably, have discretion with regard to user fee deadlines.
We are all hoping, of course, that this is an academic discussion and that no shutdown occurs.
Note: This analysis and commentary is written by Steven Grossman, the Deputy Executive Director of the Alliance for a Stronger FDA.