New drug applications pile up with delays as there's no easy fix for the inspection backlog
The FDA’s backlog of drug manufacturing facility inspections continues to be a sore spot for the agency, as FDA said Monday that a total of 52 new drug (but no biologics) applications still remain delayed due to the backlog from the pandemic.
And while the agency has maintained that it won’t issue a CRL for a delayed inspection, the number of delayed applications is rising as FDA said in May that 48 new drug applications have been delayed due to FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of last March.
The agency’s inability to work overseas has also hurt its output well into 2021, with just 37 foreign drug inspections between April and September 2021. Prior to the pandemic, the FDA typically conducted about 1,000 foreign drug inspections per year.
“FDA began the new fiscal year with ongoing travel restrictions and other uncertainties continuing to impact oversight operations. FDA is continuing to complete mission-critical work, prioritize other higher-tiered inspectional needs (e.g., for-cause inspections), and carry out surveillance inspections using risk-based approaches for evaluating public health impact,” FDA said in its new report.
The agency has sought to shift to more remote assessments of facilities, but the legal definition of an inspection is one that is conducted on site.
“As we have done throughout the pandemic, FDA will use every option available to meet our regulatory responsibilities and protect the public health, including continued collaboration with state, local, tribal, territorial, and foreign regulatory partners,” the agency added.
Despite the backlog, there were a few bright spots in the report too.
In early 2021, the FDA estimated that more than 15,000 surveillance inspections throughout the US had been postponed thanks to the Covid-19 pandemic. The agency predicted that it would complete 14% of those inspections, including 26% of the remaining human and animal medical domestic surveillance inspections. The agency exceeded that number two-fold, it reported, a completion rating of 134%.