U.S. Government Shutdown: Consequences for the FDA

In the USA, Republicans and Democrats couldn't agree on a spending plan for the fiscal year 2014, which just started on 01 October. On September 17, 2013, the Office of Management and Budget (OMB) sent out a memo advising federal agencies to begin preparing for a government shutdown. On 01 October, the United States federal government than entered the government shutdown. But what does that mean for the U.S. Food and Drug Agency FDA? Will inspections be performed? And what about submissions?

In short the general consequences are:

• Most FDA drug and device related functions will continue when funded through fees;
• Critical consumer protection functions will be continued on a select, priority basis
• Most FDA activities on food safety, nutrition and cosmetics will stop, including routine inspections and monitoring
• It seems that Warning Letters are still being issued (at least the website was updated)

Submissions:

To inform about submission processes, FDA has now set  up page on "Medical Product Activities During the Federal Government Shutdown" summarising agency activities during the "lapse period". The document lists the anticipated scope of FDA's activities from 01 October 2013 continuing until the date of enactment of an Fiscal Year 2014 appropriation or a continuing resolution for FDA.

What they will do:

• Routine product review process for submissions within the scope of the Prescription Drug User Fee Act (PDUFA) or the Generic Drug User Fee Amendments (GDUFA)  programs, provided that applicable fees were paid before 01 October2013
• FDA will accept drug submissions for which no fee is required

What they might do:

• 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.

What they will not do:

• 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.
• Certain review activities for products within the scope of the Medical Device User Fee Amendments (MDUFA) program may be suspended during the lapse period. FDA will not accept new MDUFA regulatory submissions that require fee payment
• FDA will not perform any activities with respect to drugs outside the scope of the PDUFA program.  FDA will suspend review of any pending regulatory submissions (e.g., NDAs, ANDA, BLAs, and supplements).

Source: FDA