The FDA like all Government agencies has been hit hard by the political impasse that still dominates matters in Washington DC. When the shutdown started on October 1 the drug regulator was forced to send home over half of its staff and limit activities to those considered essential.
As we reported earlier this week active pharmaceutical ingredient (API) and finished drug manufacturing facility inspections are not considered essential and have not been carried out during the shutdown.
One of the few FDA staffers still working is spokesman Steven Immergut who confirmed this for in-Pharmatechnologist.com, telling us that “no routine surveillance inspections of drugs, other than generic drugs, or compounding pharmacies taking place.
“This covers domestic and international manufacturers of both API and finished products.”
Money running out
FDA Import inspection activity has continued according to Immergut who said: “Entry screening is operating and being conducted at expected levels, the examination, sampling, and laboratory analysis of imported products is more limited due to the impact of the shutdown.”
But while some FDA activity has continued the countdown to a complete stop has already started Immergut added.
“Some medical product related activities are continuing in the near term because of the use of carry-over user fee funding. These funds are limited and will run out at some point."
The agency's concerns about running out of money were echoed by healthcare advocacy group Alliance for a Stronger FDA. Deputy executive director Steve Grossman told in-Pharmatechnologist.com that what little money is left is also being focused away from facility inspections.
“Our understanding is that staff will be able to work on applications, but that manufacturing inspections required for approval will not be.”
Overseas inspections
The FDA’s primary function, from a pharmaceutical industry perspective, is to ensure that the medicines made and sold in the US are safe. However, the regulator’s activities are also important to drugmakers and patients outside the country.
US API makers, for example, are not required to obtain a written confirmation that their products were produced to standards equivalent to European good manufacturing practices (GMP) in part because the FDA’s regulation of the industry was deemed acceptable.
Similarly, according to the European Commission (EC), API makers outside the US that want to ship to Europe can use prior US FDA inspection results to prove they are in compliance with appropriate standards.
We asked the European Commission whether the suspension of FDA inspection activities inside and outside the country would change this, particularly its listing as one of the third countries that is exempt from the ‘written confirmation’ requirement.
However, the only response we received was that: “The FDA's activities concerning the inspection of drug manufacturing plants outside the US have no bearing on the country compliance with the criteria for listing.”