Impact of partial government shutdown on US FDA

According to contingency plans drawn up by the USA’s Department of Health and Human Services, 45% of the Food and Drug Administration’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a government shutdown, say Ricardo Carvajal and Kurt Karst on law firm Hyman, Phelps & McNamara’s FDA Law Blog, commenting on the stalemate resulting from the failure of agreement on the US budget.

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 (eg, drugs and tobacco products), they suggest.

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.