The furloughs may only be on a temporary basis, however, as the House and Senate figure out how to reconcile their political differences over not only the budget, but the Affordable Care Act, which is set to take effect Tuesday and which House Republicans have vowed to dismantle for years. The FDA still anticipates continuing “vital activities” for the government shutdown.
Among what the agency deems vital is “critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”
Of the more than 8,000 FDA staff that will be retained, or about half of the agency’s total staff, 578 will continue to inspect products and manufacturers, including those in the pharma industry, as well as active inspections, recalls, emergency response.
Another 120 staff overseeing and conducting adverse event reporting, lot release protocol reviews as well as providing support for surveillance, product incidents, compliance, recalls and emergencies.
But the agency also said that FDA will be forced to cease safety activities such as routine manufacturing facility inspections, some compliance and enforcement activities, monitoring of imports, and the majority of the laboratory research necessary to inform public health decision-making.
Unknowns
But as of 5 PM EST, the details of who exactly will be furloughed and what exactly will be halted at the agency have yet to be decided as the House was expected to pick up the spending bill later tonight.
FDA spokesman Stephen King told us, “We still are reviewing what functions and activities would be performed under a furlough and we will issue a public communication about our operating status as soon as we have finalized our plans.”
“By the way, we will be working regardless if the government shuts down tomorrow,” he added.
In addition to the FDA issues, the US NIH (National Institutes of Health) is expected to see significant layoffs that will have a major impact on clinical trials. The 734 excepted to protect property related to on-going medical experiments is a subset of the over 8,000 people that work in 1,140 intramural research laboratories and clinical branches.
But even though the government is shut down, agencies can still obtain White House approval for other essential activities despite the absence of a 2014 budget. But how many of these excepted employees will be from the FDA depends on how the White House decides on the agency’s mission.