The US Government initiated a shutdown last night after politicians arguing over Obamacare failed to agree a new budget. The decision will see 800,000 Federal employees - including staff of the US Food and Drug Administration (FDA) - forced to take unpaid leave and bring a halt to all non-essential activities.
How the US shutdown will impact operations at the FDA is still very much a topic of debate, however the agency has stated that it will continue to conduct all essential activities.
Whether these essential activities will include inspection of domestic and foreign drug ingredient production facilities is not clear, but according to the European Commission (EC) this work is likely to continue.
The Commission told in-Pharmatechnologist.com it “has had no indication of reduced inspection activities by the FDA.”
API import waiver
Continued FDA inspections would be good news for European drugmakers that source active pharmaceutical ingredients (APIs) in the US.
Such regulatory activity is one of the reasons manufacturers in the country were granted a waiver from European import requirements introduced in July.
If this situation changes and the US Government shutdown does hinder the FDA’s inspection activities the European Commission may reconsider the US waiver.
A Commission spokeswoman told us that: “Should such changes [to FDA inspection activities] be confirmed, the Commission will consider whether a reassessment of the country compliance with the criteria for listing is necessary.
“Listed countries are expected to notify any important changes in the conditions under which the listing has been granted.”
The UK Medicines and Healthcare products Regulatory Agency (MHRA) told this publication that “it is too early to say what the impact [of the US shutdown] will be.”