US FDA will take time to recover from shutdown but drug firm delays will be minimal says advocacy group
US Politicians’ failure to agree a budget on Friday January 19 triggered a Government shutdown and prompted US agencies cease work programmes and told employees to go home without pay.
As a result the US Food and Drug Administration (FDA) stopped accepting user fees and regulatory submissions. The agency only furloughed 42% of its staff.
The shutdown lasted just three days, ending on Monday when politicians agreed a temporary funding Bill.
But despite the shutdown lasting only a day, it is likely to take the FDA a considerable time to catch up according to the Alliance for a Stronger FDA, an advocacy group committed to ensuring the agency has sufficient resources.
An Alliance representative illustrated the impact with a hypothetical, telling us, “If an [FDA] office has 100% utilization with its current workload and misses five days, then it will take a long time until they reach the same point they would have been without a shutdown.
“They will be a week behind until they can work off 5 missed days with no spare capacity to do so—105% and 110% weeks will eventually catch them up.”
Despite this, the Alliance is confident that the impact on drug companies seeking Agency approval will be minimal.
The representative told us, “No company or product will necessarily suffer more than a week’s delay,” adding, “it is the office that bears the brunt of catching up.”
He also stressed the importance of having a functioning and appropriately funded Food and Drug Administration (FDA).
“If FDA were to disappear, then sick people die and patient safety is at risk. However, work is always being triaged and this is true during as well as after a shutdown.
“There is a lot of work that has to be done that doesn’t have immediate front-line patient consequences and presumably the FDA will try to let that work be delayed rather than patient safety issues,” he said.
