The FDA unexpectedly closed its on-site facility inspections in early March in order to keep all its employees safe and protected from the novel Coronavirus. More than two months have passed, and drug makers are now calling for relief. With new rules and guidance, the FDA shows that it might be willing to accommodate.
The agency is currently working with the Centers for Disease Control and Prevention to work out an efficient phased approach so that inspections of domestic and foreign drug manufacturing facilities can be restarted as soon as possible. The FDA has not provided any details on how the rollout would work, but according to analysts, the plan will most likely continue with an increased focus on high-priority inspections on a case-by-case basis.
So far, the FDA has been using various volunteer teams to conduct the inspection of facilities termed mission-critical. In light of the extensive facility checks, the agency has also improved its alternative quality control methods, like examining the physical product at the border, reviewing compliance records, and sharing inspection-related information with all foreign governments. The FDA’s willingness to consider the proposal of resuming on-site inspections could offer a break to foreign manufacturers that have pleaded for an avenue for bringing their drugs and pharmaceutical ingredients to the U.S. market.
In April, prominent Indian pharmaceutical companies reached out to the FDA asking to conduct desk reviews or virtual facility inspections amidst the pandemic in order to make sure that the continuous supply of much-needed drugs is maintained. The FDA responded to it by saying that it had not conducted any virtual inspections but also added these alternative approaches to the on-site inspection of facilities had provided it with useful insights. The FDA’s move to restart on-site inspections would significantly help drugmakers put their supply chains back in order after the U.S. reported shortages of critical drugs during the pandemic.