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Rita Peters is editorial director of Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
US government agencies, including FDA, faced the first shutdown in 17 years when the House of Representatives and Senate failed to reach agreement on a budget.
US government agencies, including FDA, faced the first shutdown in 17 years when the House of Representatives and Senate failed to reach agreement on a budget. While national parks and landmarks, including the Statue of Liberty were closed on October 1 and thousands of government workers were idled, FDA expects to retain approximately 55% of its staff during the current partial government shutdown.
According to a Department of Health and Human Services statement, FDA will continue limited activities related to its user fee-funded programs. The agency will also continue “select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”
The agency reports that it will not support the majority of its food safety, nutrition, and cosmetics activities and may have to cease safety activities such as “routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.
Reviews of pending approvals for several drugs, originally scheduled for early October, were uncertain as of Oct. 1.
A provision by House Republicans to delay the implementation of the Affordable Care Act appears to be the major sticking point to an agreement. If elected officials get past this roadblock, the next big debate, over increasing the debt ceiling, is just two weeks away.