Regulatory Focus™ > News Articles > Shutdown Resolved, FDA Staff Returns to Work (and Backlogs)

Shutdown Resolved, FDA Staff Returns to Work (and Backlogs)

Posted 17 October 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration will, as of 17 October 2013, be up and running with something it hasn't had in nearly three weeks: a full staff.

The agency had been operating at a vastly reduced staffing level as the result of a partial shutdown of the US government's operations after legislators failed to pass a budget for the 2014 fiscal year. As a result, 45% of FDA's staff had been sent home, with the rest working either as a result of their job functions (i.e. those deemed "essential") or thanks to substantial reserves of user fees that allowed staff members to continue reviewing already-submitted applications.

Back to Work

But 16 days after the shutdown began, legislators agreed to-and the president signed into law-a continuing resolution that will see the government funded through the next few months.

Shortly thereafter, the Office of Personnel Management (OPM), led by acting director Elaine Kaplan, announced that the federal government would be open for business on 17 October 2013, and that all federal workers should return to work as of that time.

"Agencies are strongly encouraged to use all available workplace flexibilities to ensure a smooth transition back to work for employees (e.g. telework, work schedule flexibilities, and excused absence for hardship situations)," OPM wrote in a notice.

The Work to be Done

But the real difficulties may yet lie not in getting to work, but dealing with the work present when FDA staff arrives.

Companies, which have not been able to make applications to FDA since 30 September, will likely generate an instant backlog. Emails which furloughed staff have not been allowed to respond to in weeks need to be attended to. Potential problems need to be addressed; facilities inspected; Warning Letters generated; guidance and regulations submitted to the Office of Information and Regulatory Affairs (OIRA) and the Office of the Federal Register (OFR).

The list goes on.

The net effects of those challenges may be difficult to gauge at first, but are worth keeping a close eye on in the coming weeks.

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