FDA Shutdown – Preparing for the Likely Government Shutdown

***UPDATE: Congress approved a short term budget deal that will fund the government through December 11th. There remains a liklihood that a FDA shutdown could occur if a deal is not reached before then. The final quarter of the year will likely experience a rush to submit filings to the FDA in anticipation of a December shutdown. More on the short term budget here.***

The end of September marks the close of the Federal Fiscal Year (FY). The close of one FY is also the close of annual registrations and reduced filing fee qualifications (e.g. medical device small business qualification under MDUFA).

In a previous post (click here) we discussed what steps importers and domestic facilities must take to plan for the new FY. Typically this is a routine renewal of registrations for medical device and drug facilities or submission of the new reduced filing fee qualifications. In general the end of September is a quiet time where few filings occur due to the limitations of the end of the fiscal year.

This year, like in 2013, there is a new element to consider when working with the FDA. Media outlets report the odds of a federal government shutdown at 75% (click here). 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 inspections.

Regulatory planning at this stage should begin to calculate-in delays due to the likely shutdown. The length of the shutdown will determine the degree of the impact. 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.

There may still be some chance a new budget is passed in the waning legislative days before Congress. Please contact our Washington D.C. or Charlotte offices with any questions about regulatory planning, registrations, or the potential impact of a government shutdown.