More FDA Furloughs Expected, Gottlieb Warns

Regulatory NewsRegulatory News
| 21 January 2019 | By Zachary Brennan 

As the government shutdown enters its second month, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb and fellow leaders at the agency will be tasked with difficult decisions on who to furlough.

The agency is expected to halt its review of prescription drug applications around the first week of February, and other medical products reviewed under user fee laws will follow suit in the coming months.

“As our biggest user fee program, PDUFA, begins to run out of money, we have many more hard decisions ahead of us,” Gottlieb said Friday before a meeting on e-cigarettes. “As application workload declines, because we haven’t received new applications, we’re going to be required to furlough additional staff. We simply won’t have enough PDUFA-related work to support all of our staff. This is among the hardest and most painful decisions we have to make. It’s another consequence of the prolonged shutdown. We’ll maintain our critical safety functions and preserve as much of our review functions for as long as we can.”

According to new statistics released Friday, FDA’s 17,397 staffers are now divided into four categories: 37% exempt (meaning still paid), 31% furloughed, 23% partially exempt/excepted/furloughed (paid for exempt work) and 9% excepted (working without pay).

If the shutdown lasts until PDUFA funds run short, more employees in the exempt bucket will be shifted to the furloughed or excepted.

But a furlough official notice from FDA offers some hope for working, noting that such non-pay status, as of Monday, is not expected to exceed 30 days. “Therefore, this furlough notice expires on February 19, 2019.” The notice also informs FDA employees that if furloughed, they are not allowed to work for the government as unpaid volunteers.

“We’re in unfamiliar territory. This is a watershed moment in the life of this agency. We’ll come out stronger for having faced together this challenge, and for having prevailed,” Gottlieb added on Friday. “But the road between now and the end will be marked by continued hardships for our people, and continued impacts on our work as we focus on preserving certain functions.”

And the shutdown-related staffing issues are not the only difficult employment decisions FDA is going to have to make in 2019. According to a workforce planning report to Congress last June, the agency says that more than 40% of senior leadership will be eligible to retire this year.


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