Government Shutdown Closes Down Some FDA Work

FDA will continue with some operations during the January 2018 federal government shutdown, but activity related to fiscal year (FY) 2018 business, including regulatory submissions for FY 2018 that require a fee payment, are on hold. The agency noted in a statement and on Twitter that it will continue to support activities funded by carryover user fee balances, which would allow the agency to review some medical products during the shutdown.

In a statement, the agency said agency operations would “continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.”

More than 40% of FDA’s workforce has been furloughed.

Mission critical, public health activities that will continue during the shutdown include maintaining core functions to handle and respond to emergencies, supporting high-risk food and medical product recalls, pursuing criminal and certain civil investigations that threaten public health, screening food and medical product imports, and addressing the ongoing IV saline shortage that was exacerbated by the 2017 hurricanes in Puerto Rico, FDA reports. The agency is also monitoring widespread flu activity.

The federal government shut down on Jan. 20, 2018 after Congress failed to pass a budget appropriation or a continuing resolution to keep the government open.

Sources: FDAScott Gottlieb Twitter Feed