The US Food and Drug Administration (FDA) was forced to send home nearly half of its 8,000 strong workforce last week after politicians’ failure to agree a budget for 2014 prompted the Government to halt or shutdown all non-essential programmes.
While the agency's review of drug products has been relatively unaffected, its manufacturing plant inspection activities have halted according to a contingency plan issued last week.
In the document the agency says it has stopped “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.”
Understandably given the furlough the FDA was unable to respond to a request for data about the number of planned inspections that have been postponed during the shutdown so far. However, a search of the agency’s database suggests that it conducts at least three visits to manufacturing plants a month.
Inspection backlog
When the shutdown began on October 1, many observers expected that the crisis would prompt politicians to quickly settle their differences with most predicting that it would last only a few days.
However, with the political impasse looking set to enter its third week, early hopes of a swift resolution are fading.
The Alliance for a stronger FDA (ASF), a US healthcare advocacy group, said: “The shutdown will end, we just don’t know when. At that point, FDA will have a huge backlog of work to do, but everyone will sigh with relief.”
Debt ceiling complication
A further complication is that on October 17 the US debt is expected to pass the $14.3tr limit. When this happens the US Government will either have to ask for the limit to be raised or drastically reduce its spending, which would also impact the FDA.
Late last week Republicans in the US House – whose opposition to Obamacare was at the heart of the disagreement that led to the shutdown – proposed a six week extension on the debt ceiling, but again declined to agree a 2014 budget.
The Alliance for a stronger FDA said: “The best case for FDA is that the government shutdown ends as part of a deal on the debt ceiling. However, the lack of progress and the Republican offer covering only the debt ceiling is discouraging.
“The worst case for FDA is that a debt ceiling deal becomes politically possible only if House Republicans retain negotiating leverage by continuing a government shutdown.”