Gov't Shutdown Halts FDA Product Submissions and Other Functions

Planning to submit to the FDA today? Think again. The agency put a forced pause on key services and functions – and furloughed 6,620 FDA employees – as a result of last night’s government shutdown.

Stephen King, a member of CDER’s communications team at FDA, said in an email that “no new regulatory submissions that have fees attached” – including NDAs – “will be accepted for 2014 until the date of enactment of a [fiscal year] 2014 appropriation or a Continuing Resolution.” King did not respond to the question of whether products already accepted for FDA review would face potential delays as a result of the shutdown.

While FDA awaits a budget appropriation or continuing resolution, it will be limited to the following tasks, according to an official statement:

• Emergency work involving the safety of human life or the protection of property;

• Criminal law 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), Medical Device User Fee Amendments (MDUFA), Animal Drug User Fee Act (ADUFA), Animal Generic Drug User Fee Act (AGDUFA), and Family Smoking Prevention and Tobacco Control Act. Carryover user fee balances will only be spent on activities for which the fees are authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

As described in a Department of Health and Human Services (HHS) contingency plan for the shutdown, FDA will be “unable to support the majority of its food safety, nutrition, and cosmetics activities. FDA will also have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.”