FDA LAW BLOG--October 07, 2013 The Shutdown: An Update on FDA Activities By Kurt R. Karst –

     

We’re now entering the second week of the shutdown of the federal government (or “the lapse period” as some have called it), and there does not appear to be an end in sight.  In fact, the environment in Washington, D.C. has been described as “toxic.”  On the FDA front, confusion (both in and out of the Agency) seems to have been the state of affairs for several days last week.  What’s on and what’s off for FDA has been an ongoing topic of discussion since before the shutdown and after FDA issued an initial statement on affected activities (see our previous posthere).  

Meanwhile, on Capitol Hill, a bill – H.J. Res. 77, Food and Drug Administration Continuing Appropriations Resolution, 2014 – cleared the House Rules Committee last week that would provide continued funding for FDA under Fiscal Year 2013 levels through December 15th, thereby effectively ending the partial shutdown of FDA (for the time being).  (A score of the bill by the Congressional Budget Office is available here.)  Although the House of Representatives passed the bill by a 235-162 vote Monday evening, the prospects of that bill, along with other bills providing appropriations for targeted government activities, getting past the President’s desk, are slim to none.  In a Statement of Administration Policy, the Office of Management and Budget indicated that “[i]f the President were presented with . . . H.J. Res. 77 [and other other similar resolutions], he would veto the bills.”

Last Friday, the Alliance for a Stronger FDA sent out a helpful list of FDA activities anticipated to be affected by the shutdown.  The list is from a posting on FDA’s website that was taken down later in the day (a copy of the original FDA posting is available here).  On October 7th, FDA reposted an updated version of the list, which we provide below for posterity (because you never know when the next shutdown might occur).  Following FDA's list are some additional notes based on our experience.

Medical Product Activities During the Federal Government Shutdown

This document summarizes the anticipated scope of FDA’s activities beginning on October 1, 2013, and continuing until the date of enactment of an FY 2014 appropriation or Continuing Resolution for FDA (the “lapse period”). Please note that FDA’s anticipated activities are subject to resource constraints on the Agency due to the lapse in appropriations and may change in the event of a protracted lapse period.

Overview

• During the lapse period, FDA activities related to medical products generally will be limited to the following:
  • Excepted work involving the safety of human life or the protection of property, including Criminallaw enforcement work; and
  • Activities funded by carryover user fee balances, including user fee balances under the Prescription Drug User Fee Act (PDUFA), Generic Drug User Fee Amendments (GDUFA), and the Medical Device User Fee Amendments (MDUFA).
• Carryover user fee balances will be spent on activities for which the fees are authorized under PDUFA, GDUFA, or MDUFA, as applicable.
• FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation or Continuing Resolution for FDA is enacted.  This means that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.
• We do not anticipate that the lapse in appropriations will affect our routine product review process for submissions within the scope of the PDUFA or GDUFA programs, provided that applicable fees were paid before October 1, 2013. We cannot predict whether we will experience delays in these programs in the event of a protracted lapse in appropriations.
• Due to resource constraints, certain review activities for products within the scope of the MDUFA program may be suspended during the lapse period.
• Generally, scheduled advisory committee meetings regarding the approval of, or postmarketing safety issues regarding, products within the scope of the PDUFA, GDUFA, or MDUFA programs may go forward during the lapse period, subject to constraints on resources and travel. Other advisory committee meetings that can be conducted with carryover user fee balances will be handled on a case-by-case basis.

PDUFA

• During the lapse period, FDA will not accept PDUFA applications or supplements that require payment of a fee (e.g., New Drug Applications (NDAs) or certain Biologics License Applications (BLAs)), unless the FY 2014 fee was paid prior to October 1, 2013.  FDA expects to continue to review PDUFA applications and supplements for which all applicable user fees were received prior to October 1. 
  • For example, for an application or supplement that requires a fee, if the FY 2014 fee was received on September 30, 2013, FDA expects to review the application, even if the application or supplement itself is submitted during the lapse period.
  • However, if an application or supplement was received on September 30, 2013 and the fee was received on October 1, then FDA will not review the submission, because it cannot accept the fee.
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