How the Government Shutdown Affects FDA Activities

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During the lapse period, the Agency will be continuing vital activities.
During the lapse period, the Agency will be continuing vital activities.

Addressing how the Food and Drug Administration (FDA) is operating in light of the current government shutdown, Commissioner Scott Gottlieb, MD said the Agency is "doing everything we can to try to maintain our basic consumer protection role."  

The consequence of the shutdown means the budget appropriated by Congress for the Agency is on hold, resulting in ~7000 of it's 17,000 employees being furloughed. Drug therapy applications that are funded by carryover user fees will continue to be worked on by the Agency. However, the FDA does not have the legal authority to accept user fees assessed for the fiscal year 2019 during the current funding lapse.

Operations still being conducted include monitoring for and quickly responding to outbreaks related to foodborne illness and the flu, supporting high-risk food and medical product recalls when products endanger consumers and patients, pursuing civil investigations when public health is imminently at risk, and screening food and medical products that are imported to the US. Mission critical surveillance for significant safety concerns with medical devices and other medical products will also continue.

What has stopped is most food safety inspections within the US. Commissioner Gottlieb plans to recall some workers in order to begin inspections again. "I think it's the right thing to do for public safety," Gottlieb told NBC news. Facilities that have had previous safety issues and foods more prone to contamination would be prioritized.

 

Gottlieb wrote in a tweet sent on Wednesday evening that, "We're taking whatever steps we can to support our colleagues as they fulfill our commitments to the American people under challenging circumstances."

For more information visit FDA.gov.

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