US Government Shutdown: Senators Agree to Deal as Almost Half of FDA Staff Furloughed
Senators from both sides of the aisle agreed on Monday to the terms to end what may just be a three-day government shut down. And thanks to the user fees paid by biopharmaceutical and medical device companies, 58% of US Food and Drug Administration (FDA) staff would have still continued to work if the government had been shut down for longer.
The continuing resolution forged by Democrats and Republicans on Monday will keep the government open until 8 February.
“FDA’s current shutdown plan provides for 58% of workforce continuing to work and 42% furloughed. The number of FDA employees continuing to work in this shutdown is projected to be an increase from past shutdowns FDA user fee programs have grown significantly since 2013,” FDA Commissioner Scott Gottlieb said in a statement on Sunday.
Gottlieb was expected to go to Switzerland’s World Economic Forum on Monday but said he, at least for the moment, will remain at FDA headquarters. It's unclear if he will still attend the Forum.
Should Congress fail to pass another continuing resolution or FY 2018 appropriation, the agency said it “will not have legal authority to accept user fees assessed for FY 2018 until an FY 2018 appropriation for the FDA is enacted. This will mean that the FDA will not be able to accept any regulatory submissions for FY 2018 that require a fee payment and that are submitted during the lapse period.”
The agency’s critical health functions would have continued, though, Gottlieb added, including with reviews of food and drug imports, tracking and addressing drug, device and other medical product safety issues as they arise, and oversee food recalls and monitor and respond to outbreaks of foodborne illnesses.
“Importantly, we will also continue to address existing critical public health challenges that the FDA has been working on, including the ongoing IV saline shortage that was exacerbated by the 2017 hurricanes in Puerto Rico,” FDA said.
FDA 2018 Shutdown Information
Editor's note: Article updated 1/22/18 with news of the deal.