The 411 on the US Government Shutdown
What did the partial government shutdown mean for the US pharma industry?
Maryam Mahdi | | Quick Read
Imbued with negative political connotations, the construction of walls (wherever they might be) polarizes public opinion. And the debate about the erection of a wall on the US-Mexico border is no exception. After Congress, which is controlled by Democratic voices, refused to release the $5.7 billion required for the construction of the barrier, it resulted in the longest government shutdown in US history (35 days), which had huge implications for the FDA. The government reopened on January 25 after President Trump signed a short-term spending bill, but it doesn’t include the money for a border wall – and it runs out on February 15, after which another shutdown could be on the cards.
During the shutdown, around 40 percent of FDA workers were temporarily laid off and the agency was unable to accept regulatory submissions that required a fee payment. The FDA tried to maintain vital activities, to the extent permitted by the law, as much as possible during the shutdown, which included core functions to handle and respond to emergencies, supporting high-risk product recalls, screening food and medical products imported to the US, and mission critical surveillance for significant safety concerns with medical devices and other medical products (1). In January, some workers returned, without pay, to work on critical areas.
On Twitter, FDA Commissioner Scott Gottlieb gave frequent updates. He described the shutdown and the resulting lapse in funding as “one of the most significant operational challenges in FDA’s recent history” (2). He added, “It is not business as usual at the FDA. Many key functions aren’t getting done. But we’re focused on maintaining core activities that directly impact consumer safety and save lives.”
The agency also held outreach events for employees on furlough to provide information and resources to help them manage during the shutdown.
The threat of another shutdown looms, however, unless President Trump and Congress can come to a deal about the US-Mexico border. Some US research agencies are already preparing for another potential shutdown (3)...
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- FDA, “FDA 2019 Lapse in Funding Information” (2019). Available at https://bit.ly/2Fuoyyj. Last accessed January 16, 2019.
- Twitter, @SGottliebFDA. Available at https://bit.ly/2t9SDLi. Last accessed February 7, 2019.
- PhysicsWorld, “US Research Agencies Prepare for New Government Shutdown,” (2019). Available at https://bit.ly/2BqIFKb. Last accessed February 7, 2019.