Then and Now – Shutdown Showdown

The last time we faced a government shut down, there were some advance communications on how various government agencies were going to be operating during the “event”. Last time, the executive brand had issued a memorandum on September 17, this time there seems to be less information about what may happen or what may not. Perhaps we are still too far out from the time or perhaps we are just getting used to it.
But in any case, it seemed like it might be a good idea to begin thinking about some of the things. What did FDA do last time?

Here are a few things to note:

  • Back in 2013 (and even in 2011), the answers ahead of time were not so black and white. There was a lot of gray area. Prepare for the same this time, even based on past experience.
  • FDA had to furlough thousands of employees and had a page set up to answer employee questions. Presumably that information will be similar for this time.
  • There was some thinking last time that while the government had indicated that only essential operations would continue during the shutdown, that some FDA activities funded by user fees might occur – such as advisory committees. It should be noted, however, that some advisory committees were postponed due to the shutdown. As of right now, there is only 1 Advisory Committee meeting and it is not scheduled until October 23 (last time there were nine meetings scheduled for October – leading one to wonder if schedulers are on to something).
  • A question raised last time was whether or not approvals and PDUFA dates would be affected – but there are press releases announcing approvals in the files that were released during that time and the media office was staffed by an individual and the agency did note that where carryover user fee funds were not available during the shutdown, that existing dates would be extended by the number of days of the shutdown.
  • Food and drug inspections might not carry forward during a shutdown.

Anyone interested on catching up on what the impact was of the last shutdown can find some reading here “Impacts and Costs of the October 2013 Government Shutdown”. Among the FDA related impacts were:

  • 500 delayed food and feed domestic inspections and 355 safety inspections under state contracts
  • delay in the approval of drugs and devices – noting in particular an inability of FDA to accept applications for approval
  • inability of FDA to answer consumer questions about regulated products

Hopefully the lack of advance word is indicative of a non-event.

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