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Posted 23 July 2021 | By Michael Mezher 

House E&C leaders grill FDA on inspection backlog

2807 Leaders of the House Energy and Commerce committee on Thursday wrote to Janet Woodcock, the US Food and Drug Administration's (FDA) acting commissioner, requesting information about the agency's plans to address its inspection backlog driven by the lull in on-site inspections during the COVID-19 pandemic.
In March 2020, when the scope and seriousness of the pandemic became known, FDA halted all but mission-critical inspections, relying instead on alternative tools such as inspection reports from foreign regulators, records requests, and product sampling to complement its oversight activities. While the agency has resumed some of its foreign inspectional activities, and as of this week has begun transitioning to its standard operations for domestic inspections, the agency is faced with a backlog of inspections numbering in the thousands.
Now, leaders of the Energy and Commerce committee, including Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Cathy McMorris Rodgers (R-WA), Health Subcommittee Chairwoman Anna G. Eshoo (D-CA) and Ranking Member Brett Guthrie (R-KY), Oversight and Investigations Subcommittee Chair Diana DeGette (D-CO) and Ranking Member Morgan Griffith (R-VA), are asking FDA for answers on the agency's return to normal operations and the impact the delayed inspections has had on product approvals. (RELATED: FDA issues long-awaited pandemic remote inspections guidance, Regulatory Focus 14 April 2021; FDA tallies pandemic inspection toll, issues new 'resiliency roadmap', Regulatory Focus 5 May 2021)
"While we understand that the emergency 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. The agency's May 2021 Resiliency Roadmap report states that even under a best-case scenario in which standard operations would have resumed for domestic inspections in May, FDA would only have been able to inspect 50 percent of its remaining fiscal year (FY) 2021 inspections of domestic drug manufacturing facilities," the representatives wrote, noting that foreign establishments would still only be inspected by US-based staff in mission-critical cases.
The letter also points to a report compiled by the Government Accountability Office in January that found FDA conducted 56 percent fewer drug manufacturing inspections in 2020 than it did in the previous two fiscal years. (RELATED: Inspections: GAO calls on FDA to plan for backlog, review alternatives, Regulatory Focus 1 February 2021; FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 9 March 2021)
The representatives also voiced concerns about the potential impact the delayed inspections might have on product approvals. "We are also concerned that we have not yet seen the full impact of delayed inspections, particularly in the case of preapproval inspections (PAIs)," they wrote.
In response, the representatives ask Woodcock to clarify when the agency intends to resume its standard operations for foreign inspections, as well as for information on the number of applications that received complete response letters that cite a deficiency related to FDA's inability to conduct an inspection.
The representatives also asked whether FDA has conducted an analysis of how delayed inspections may impact its ability to make approval decision in the near future, and whether inspection delays are behind a slip in the agency's performance in acting on biosimilar product applications before their goal date.
Additionally, the representatives asked several questions about FDA's ability to rely on inspections under its mutual recognition agreements (MRAs) with other regulators, including whether the agency is looking into such agreements with additional authorities and when the agency will make a determination on extending inspectional reliance with MRA partner countries to preapproval inspections.
Statement, Letter


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