January 28, 2019

Government Reopens: Impact on FDA

Holland & Knight Healthcare Blog
Michael J. Werner | Ethan Jorgensen-Earp | Sara M. Klock

The federal government shutdown ended Friday, Jan. 25, 2019, with the enactment of a Continuing Resolution to fund government agencies at approximately FY19 levels through Feb. 15. That means federal employees are headed back to work and will receive back pay.

For the U.S. Food and Drug Administration (FDA), this means all employees will be back at work by Monday, Jan. 28, and the FDA will be able to resume non-user fee activities. The agency can also collect additional user fees that were paid after the shutdown began, and until Feb. 15, which provides an influx of new funding. While the additional funding is welcome, it will likely take a few weeks for the FDA to return to fully operational status (and clear the backlog of work that had built during the shutdown). In addition, the shutdown's toll might be felt for months or years as the agency lost several employees during the shutdown due to attrition and its hiring efforts were stymied.

Note also that unless the FDA gets funded after Feb. 15, it will be in the same position as during the shutdown – unable to fund non-user fee activities and unable to collect new user fees. Whether Congress and the president can agree on a funding package for the balance of the year remains unclear.

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