House committee seeks more from FDA on inspection backlog, when to restart work on foreign sites
House Energy & Commerce committee leaders are raising fresh questions about the FDA’s ability to conduct foreign manufacturing site inspections and bring down its growing backlog.
“While we understand that the emergence of COVID-19 required the agency to suspend in-person inspection activities temporarily, we remain concerned that more than one year into the pandemic, the strategy for resuming all inspections and addressing the backlog of delayed inspections remains unclear,” E&C chair Frank Pallone (D-NJ) and a group of five other bipartisan leaders of the committee wrote to FDA acting commissioner Janet Woodcock.
As Woodcock struck a more optimistic tone in that announcement, the House representatives note that foreign facilities inspected by US-based staff are only subject to mission-critical inspections, and while the agency has alternative methods to inspect sites remotely, “it is largely unclear for which types of inspections, if any, FDA can appropriately use these alternatives as a full substitute for an in-person inspection,” the representatives wrote.
For example, remote evaluations cannot satisfy the statutory requirement for surveillance inspections, as those must be either onsite or conducted by the FDA’s foreign counterparts. The agency said it postponed nearly 8,000 non-mission-critical surveillance inspections in 2020 due to the pandemic.
“We are also concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections (PAIs). PAIs may occur well in advance of targeted dates for drug approval decisions. Therefore, drug applications and approvals may be affected in the future if inspections continue to be postponed, possibly delaying patient access to needed medications,” the letter says.
According to a report from the FDA in May, an estimated 68 applications (including 48 for different drugs) have already been delayed due to the FDA’s inability to conduct pre-approval, pre-market, or pre-license inspections as of March.
The lawmakers also questioned Woodcock, seeking responses by Aug. 5 on whether the agency has an analysis to determine how delayed inspections may impact the agency’s ability to make drug approval decisions in the coming months and years.