Government Shutdown

A government shutdown now seems increasingly likely (see, Reuters latest headline). This blog wrote extensively on the 2013 Government shutdown (here, here, and here). Although unpredictable and difficult to plan around on short-notice it is important to be aware of the impact this could have. One that affects both industry and consumers.

In the event the government does shutdown, all non-essential employees will be furloughed. The result will be moderate to severe delays in reviewing submissions, including pending 510(k)s, GRAS notices, pre-NDA request, and other user-fee and no-fee submissions. It will also pose a risk to the public through the halt in routine facility inspections.

Regulatory planning at this stage should begin to calculate-in delays due to the likely government shutdown. The length of the shutdown will determine the degree of the impact. If funding is passed over the weekend, then the impact may be very small. Any longer and the impact will be far-reaching. Pre-market applications may be delayed by 30-45 days by a shutdown lasting one to two weeks. Responses to Warning Letters, Regulatory Status Calls, or Form 483s could be delayed by as much as 60-days. The effect will be hard to predict, but delays of some length can be expected.

This was the case with the 2013 shutdown. The nearly three-week-long government shutdown created a huge backlog of unprocessed requests, including establishment registration fees, pre-market approval submissions (NDAs, 510(k)s), and other outstanding requests, like detention orders and advisory meetings. That was compounded by three weeks of missed correspondence.

While the government may shutdown industry will still be at work. There may still be some chance a new budget is passed in the waning hours before Congress.

**Disclaimer: Marc C. Sanchez, Esq. is a FDA attorney in private practice and the above is not intended as legal advice. FDA Atty law firm is hosting this blog solely for educational purposes.**