FDA Outlines Priority Plan for Inspections

The FDA said yesterday that it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September.

In a new report, the agency outlined projections on how it could return to a more normal schedule of inspections based on three pandemic scenarios — most likely, best case and worst case.

The agency’s plan involves three tiers of postponed drug facility inspections: mission-critical (tier 1), higher-priority (tier 2) and lower-priority (tier 3).

Under the most-likely scenario, the agency estimates that it can take care of 851 (26 percent) of the 3,229 human and animal medical product domestic inspections scheduled but not yet completed in the rest of fiscal 2021.

In the worst-case scenario, where new variants emerge and/or new pandemic-related challenges occur, the agency said it would continue to rely more heavily on alternative oversight tools, which it has used extensively to conduct oversight of drugmakers during the pandemic.

The report includes figures on agency inspection numbers during the pandemic. For example, it shows that from March to September 2020, the FDA conducted 25 domestic and foreign mission-critical inspections for drug facilities. The agency stayed within sight of that number from October 2020 to March 2021, conducting 24 inspections. Pre-pandemic the agency carried out 143 inspections from March to September 2019 and 110 inspections from October 2018 to March 2019.

For prioritized (but not mission-critical) domestic drug facility inspections, the agency conducted 51 inspections from March to September 2020, and even increased that number from October 2020 to March 2021, hitting 55 inspections.

As of March of this year, an estimated 48 drug applications had been delayed because pre-approval, premarket or pre-license inspections could not be conducted, with six of those applications seen as mission-critical. Only one biologics application saw its decision delayed in that time period.

The report shows that in fiscal 2019, the agency was able to take care of 94 percent of its planned 18,000 routine surveillance inspections. However, in fiscal 2020, the pandemic limited the FDA to fulfilling only 61 percent of its 21,000 planned routine surveillance inspections. For fiscal 2021, the agency has set a target of conducting 26,250 surveillance inspections. As of March, it had inspected 2,953 of those companies, or around 11 percent.

The figures also show that, in fiscal 2020, the agency conducted 90 percent of its planned 79 domestic follow-up activities related to Official Action Indicated (OAI)/compliance follow-up, with eight inspections postponed. This fiscal year, the agency has so far conducted 49 of its 164 planned domestic OAI/compliance inspections, leaving 115 to go.

Read the full report here: www.fdanews.com/05-05-21-ResiliencyRoadmap.pdf. — James Miessler