FDA could furlough nearly one-fifth of staff by Sunday

If US lawmakers are unable to negotiate a deal to prevent a government shutdown by 1 October, the US Food and Drug Administration (FDA) will have to furlough almost one-fifth of its staff and halt work that could have a critical impact on medical products industries.

As a government shutdown looks inevitable, FDA has published a contingency plan that states it will immediately have to furlough 19% of its staff until it receives more appropriations monies. Under the law, the agency can retain 64%, or 12,300 staff members, who are considered exempt from appropriations because they are either funded through the executive branch, carryover user fees, Working Capital Fund or COVID-19 supplemental funding.

While user fee carryover funding may eventually run out, the reserves can continue to be used for user fee activities such as approving new products, reviewing clinical research and publishing guidances. FDA, however, cannot accept any new user fees during a government shutdown.

Focus asked FDA how much carryover funding the agency has for each user fee program and how long the funding is expected to last, but the agency stated they could not provide that information at this time.

FDA will also retain 3,302 staff members, an additional 17%, who are either critical to address imminent health threats, are needed to protect property, or are authorized to continue working as they are related to other necessary work.

“Excepted FDA staff will continue to perform vital tasks related to imminent threats to the safety of human life including detecting and responding to emergencies, managing recalls, pursuing criminal enforcement work and certain civil investigations, reviewing import entries to determine potential risks to human health, conducting for cause and certain surveillance inspections of regulated facilities, conducting surveillance of adverse events reports for issues that could cause human harm, and other critical public health issues as appropriate,” said FDA. “These excepted staff will also be responsible for continuing efforts to address other serious public health challenges, including drug shortages, and outbreaks related to foodborne illness and infectious diseases.”

The agency noted that 229 Public Health Service Commissioned Corps officers will also continue to work at FDA if appropriations funding is halted.

Alliance for a Stronger FDA, a group that advocates for increased agency funding, published a report on 22 September arguing that a government shutdown is likely to occur. Typically, lawmakers pass a continuing resolution to keep the government funded while they hash out their differences, the Alliance noted. This time, however, the group argued the differences between the Democratic-run Senate and a faction of the Republican-run House appear too great to be resolved in time to avoid a shutdown. It also noted that hardline House Republicans have vowed to shut down the government rather than pass a month-long continuing resolution.

“As of September 22, a government-wide shutdown on October 1 seems likely,” said the Alliance. “If a CR is passed in time to avoid a shutdown now, that may push the shutdown threat forward to the last day of the continuing resolution.”

The group said a last-minute solution may be found to avoid a government shutdown but it “seems less and less likely.”

The Alliance also noted that during the most recent 2018-2019 government shutdown, most FDA websites were not updated. While some online portals were accessible for industry stakeholders, agency personnel were not always available to respond to online inquiries.

As more and more of the agency’s work has moved online, the group said the lack of online response could have a bigger impact if there is a government shutdown.

FDA contingency staffing plan
Alliance for a Stronger FDA report

FDA could furlough nearly one-fifth of staff by Sunday

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