FDA tallies pandemic inspection toll, issues new 'resiliency roadmap'

Regulatory NewsRegulatory News | 05 May 2021 |  By 

A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward.
“The numbers reveal the state of our inspectional oversight and how we plan to address postponed inspectional work using a risk-based approach,” wrote acting FDA director Janet Woodcock, MD, in a forward to the Resiliency Roadmap for FDA Inspectional Oversight.
Inspections were largely halted in March 2020 when the scope and seriousness of the global pandemic became known. Some inspections were deemed unavoidable, despite the risks of travel and in-person activities during the pandemic, so FDA staff did conduct a limited number of in-person domestic and foreign exemptions even as COVID-19 cases mounted. From March 2020 through March 2021, FDA conducted a total of 49 “mission-critical” in-person inspections in support of its oversight of human drugs.
The agency also completed eight mission-critical in-person inspections related to medical devices and radiological health and 10 biologics-related mission-critical inspections. A total of 29 of 821 mission-critical inspections were conducted in foreign countries, though food- and animal drug-related inspections are part of those totals.
FDA’s approach to resuming inspections was informed both by the risk of the pandemic and by a risk-based analysis to identify which inspections needed to be prioritized. The report breaks inspections down by the period from March through October 2020, and from October 2020 through March 2021. According to FDA’s tally, 68 out of over 13,500 applications for medical product approval or authorization have been delayed because of inability to conduct inspections since March 2020.
In the first half of that 12-month period, inspections related to human drugs, devices and biologics numbered 51, 30 and 22, respectively. The figures in each category rose in the second half of the year, to 55, 42 and 31, respectively. (RELATED: FDA’s inspection backlog: GAO raises concerns as delays mount, Regulatory Focus 09 March 2021)
Eight of 79 domestic for-cause inspections were delayed in FY20. A total of 115 such follow-up activities need to be completed in FY20 in order for the agency to meet its performance target in this area.
“While FDA has continued many of our oversight activities, there is no doubt that the pandemic has had an impact on our inspectional work,” wrote Woodcock in a forward to the report, which, she said, was issued “in the spirit of transparency.”
As the agency has detailed previously, FDA also “looked at existing oversight tools and authorities and considered ways to optimize our surveillance and weave new approaches into our oversight scheme,” according to the report. Such alternatives included records reviews and using remote inspections. The latter approach was applied primarily to human and animal food importers.
Trusted foreign regulatory partners were also engaged through mutual recognition agreements (MRAs) and other confidentiality agreements. FDA noted in the report that information exchange via MRAs with the UK and the EU was already up and running before the pandemic, but the agency increased its reliance on these agreements during the pandemic. Another agreement with New Zealand, Australia and Canada allowed FDA to rely on inspections by local regulators in those countries.
“In response to the global pandemic, FDA assessed expanding the use of MRA beyond in-country inspections to include third-country inspections and has begun to accept and classify third-country inspections conducted by countries deemed capable under section 809 of the [Food, Drug & Cosmetics] Act,” wrote the agency in the report.
FDA also participates in a similar mutual recognition program for medical devices, the Medical Device Single Audit Program (MDSAP), through the International Medical Device Regulators Forum (IMDRF). In this case, one regulatory audit “satisfies the requirements of multiple regulatory jurisdictions.”
In FY20, 2,842 facilities were inspected through MDSAP, and an additional 536 had been conducted by the end of March 2021.
A final alternative to facility inspections is to perform risk-based sampling and testing of products domestically and at international borders; this approach was one factor that led to FDA’s decision to put all hand sanitizers from Mexico on import alert early in 2021. (RELATED: FDA puts all Mexican hand sanitizers on import alert, Regulatory Focus 27 January 2021)
For each regulated commodity, FDA has set forth priorities for inspections ranging from those deemed mission critical, to higher- and lower-priority categories. The report also lays out its predictions of how a variety of scenarios will impact future inspections, taking an approach that takes into account the unpredictability of the future path of the pandemic around the world. This section of the report details the most likely scenario, as well as a best-case and worst-case possibility.
Through these exercises, FDA is laying plans to achieve “a more consistent state of operations…going forward,” noted Woodcock.


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