US FDA has stopped taking fees and accepting drugs for review as a result of shutdown

The US Government shutdown on Friday after politicians failed to agree a budget  for the year.

Federal agencies are required to halt most activities and ‘furlough’ – enforce temporary leave upon - non-essential personnel.

The US Food and Drug Administration (FDA) announced that it does not have legal authority to accept user fees assessed for FY 2018 until an FY 2018 budget is settled.

It explained, “This will mean that the FDA will not be able to accept any regulatory submissions for FY 2018 that require a fee payment and that are submitted during the lapse period.”​

“FDA will be unable to support the majority of its food safety, nutrition, and cosmetics activities.”​ 

The agency also said it will, “have to cease safety activities such as routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs, and the majority of the laboratory research necessary to inform public health decision-making​.”

FDA Commissioner Scott Gottlieb outlined the agency's shutdown plan in a thread  on twitter. He also confirmed the organisation will furlough 42% of its staff.

The US Senate is due to vote whether to end the shutdown this afternoon​.

The Alliance for a Stronger FDA​, an advocacy group committed to ensuring the agency has sufficient resources, told us, "FDA provides services that are core functions of government. And when FDA is unable to perform them as in a shutdown, there is no one other entity public or private that can pick up the slack. So, it seems particularly wrong that FDA is caught up in an unrelated partisan fight and that consumers, patients and industries will be short-changed​."

"The degree of damage to FDA depends a lot on how long a shutdown lasts and how effective the agency is in allocating resources to urgent and emergency tasks, both during a shutdown and immediately after. A short government shutdown will have consequences, but few are likely to be visible. The amount of time the agency will need to catch-up is probably longer than people realize, especially in offices that have vacancies and are already under heavy workload pressures​."