• As Partial Government Shutdown Kicks In, FDA’s Foods Program Is Hardest Hit
  • October 3, 2013 | Authors: Ricardo Carvajal; Kurt R. Karst
  • Law Firm: Hyman, Phelps & McNamara, P.C. - Washington Office
  • According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations - popularly referred to as a government shutdown.  Now that the shutdown has materialized, the effects will be felt throughout the agency, but the blow is likely to be softened (at least in the near term) for centers that operate programs funded by industry-paid user fees (e.g., drugs and tobacco products).  For those FDA components, carryover balances from user fees previously collected under the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments, the Medical Device User Fee Amendments, the Animal Drug User Fee Act, the Animal Generic Drug User Fee Act, and the Family Smoking Prevention and Tobacco Control Act can be spent - until exhausted - on activities for which the fees are authorized under the statute.

    That’s not to say programs funded by user fee carryover balances will escape unscathed.  As indicated in a notice posted on FDA’s website on the first day of the shutdown (referred to as "the lapse period"):

    With respect to medical product user fees, during the lapse period, FDA will not have legal authority to accept user fees assessed for FY 2014 until an FY 2014 appropriation for FDA is enacted. This will mean 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.

    Hardest hit is FDA’s foods program, which is generally not funded by user fees.  By all accounts, the majority of activity in that program has ground to a halt.  In particular, notification programs such as those for GRAS uses of substances, food contact substances, and infant formula have ceased operation, leaving a number of submissions in limbo.

    The effects of the shutdown will also be felt in relation to services that are not center-specific.  For example, the Division of Dockets Management is shuttered and will remain so indefinitely.  It is not clear how, in the interim, any submissions that must be made in person at the Division of Dockets Management will be handled (e.g., original citizen petitions).  For routine docket submissions, the regulations.gov website says: "You can still submit comments to agencies using Regulations.gov during the shutdown."

    Also, it appears that other operations, such as recall operations, have been significantly curtailed and that remaining resources will be focused as necessary for the protection of human life.