FDA Gears Up for Potential Government Shutdown

Agency would have to put 40% of its workforce on unpaid leave. Drug approvals may slow.

The Trump administration is now saying that it can find the $5 billion it wants to build a border wall without forcing a government shutdown at the end of the week over a budget impasse with Congress. Such a shutdown would have a big effect on the FDA, Stat reports this morning, because the FDA wasn’t one of the agencies that Congress earlier this year sought to protect with emergency funding that would keep it running even during a shutdown. If the shutdown does in fact occur (and right now it’s a shifting story), the FDA would have to put 40% of its workforce on unpaid leave of absence.  

“A shutdown at the FDA is more complicated than at some other federal agencies, in part because so-called user fees from drug and device companies help support much of the workforce,” Stat reports. “Even if federal appropriations stop flowing, individuals whose work is funded by user fees may continue their work. That includes many regulators who oversee drug and device applications, as well as some staff who work on regulating tobacco.”

Other FDA employees who would continue to work include people who respond to disease outbreaks, drug shortages, and recalls.

Still, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, a nonpartisan advocacy group, tells Stat that any drug company that wants to file a new application should do so quickly.

“This is ‘just in case,’ because in the past there has been a distinction between product reviews on which fees have been paid … and those on which a fee had not been paid at the time of the shutdown.”