US FDA to focus only on ‘mission-critical’ foreign inspections
With cases of the coronavirus still growing globally, the US Food and Drug Administration (FDA) has taken a precautionary step of following government recommendation to limit travel for government employees.
The decision was reached due to a ‘number of factors’, the aforementioned travel prohibition, as well as access restrictions being imposed by various countries, and the safety of the agency’s staff, the FDA stated.
This means that the agency will forego all inspections of foreign facilities, except those judged to be ‘mission-critical’.
Despite the limitations this will place on the physical inspections of sites, the FDA stated that it was able to reach the decision based on “the confidence we have in our ability to maintain oversight over international manufacturers and imported products using alternative tools and methods.”
Amongst the alternative tools it will use, the agency suggested that it would deny entry of unsafe products into the US, perform physical examination or product sampling at borders, make decisions based on companies’ previous compliance history, and by sharing information with foreign governments.
Further than this, the agency moved to reassure the US public that it was taking action against the virus: “Our leadership team meets daily to talk about the myriad of urgent issues facing us as we actively facilitate efforts to diagnose, treat and prevent the disease.”
The news of inspections halting follows on from the news that the first drug shortage had been reported due to a site affected by the coronavirus. At the time, Stephen Hahn, FDA commissioner, had warned that it would likely not be the only shortage faced during the course of the virus.
This stance was backed up by the action of Indian government only days after to limit the export of certain active pharmaceutical ingredients, which caused concern among European manufacturers about supply issues.