The US shutdown has been well publicised and commented on throughout the world. I’m not going to get political about the rights and wrongs of the situation – but what effect, if any, does it have on the pharma research community?
1st October heralded the start of a new financial year for the US government and without agreement on a budget, they took the only action they could under US legislation – to temporarily shut down all “non-essential” services – forcing many government workers to take unpaid leave.
Senators are not covered by the same rules and so will continue to be paid – to be fair though, more than half, across the political spectrum have refused to take their salary during the shutdown or have said they will donate it to charity.
Two weeks later and there is talk of a compromise deal but as yet, nothing on the table. By the time I finish writing this, everything may have changed of course…
So where does this leave the FDA – and the wider research community?
The Government’s own website carries the following slightly chilling comment “research into life-threatening diseases and other areas will stop, and new patients won’t be accepted into clinical trials at the National Institutes of Health.”
Around 45% of the FDA’s nearly 15,000 staff are now on unpaid leave (furlough), which clearly has a major impact on its operation.
The FDA’s website outlines the pharmaceutical-related activities that will still continue:
- Excepted work involving the safety of human life or the protection of property, including Criminal law enforcement work will continue, as will:
- Activities funded by carryover user fee balances – including those under the Prescription Drug User Fee Act, Generic Drug User Fee Amendments, and the Medical Device User Fee Amendments.
- FDA will not be able to accept user fees assessed for the new financial year. This means that FDA will not be able to accept any regulatory submissions for FY 2014 that require a fee payment and that are submitted during the lapse period.
- The FDA does not expect that the shutdown will affect its routine product review process for submissions within the scope of the PDUFA or GDUFA programs – provided of course that the applicable fees were paid before 1st October. However, there will of course reach a point where the shutdown will start to cause serious delays.
- Due to resource constraints, certain review activities for products within the scope of the MDUFA program may be suspended during the lapse period.
A week or two may not seem a long time in clinical research but as the shutdown drags on, the resources needed to get back on track will grow exponentially. Let’s hope that a solution is found – and found quickly.
I’d love to know what you think!
Blog Author: Dr. G.C. Practice
