FDA Inspection “Roadmap” Acknowledges Continued Delays and Challenges Ahead

Jill Wechsler
Jill Wechsler

Jill Wechsler is BioPharm International's Washington Editor, jillwechsler7@gmail.com.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

Efforts to return to a more consistent and timely federal field inspection program will take considerable time, as FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic. With a huge backlog built up since March 2020, it’s not clear when the agency’s inspection program for drugs and medical products will fully recover. These challenges are acknowledged in the recently issued “Resiliency Roadmap for FDA Inspectional Oversight,” which details how the pandemic has delayed all but the most important “mission critical” and high priority inspections this past year, leaving thousands of site visits that will need attention in the coming months—and years.

The Roadmap reports that FDA was able to carry out approximately 1600 mission critical and high-priority inspections for all regulated products from March 2020 to March 2021, including 29 in foreign countries. However, that is far short of the more than 20,000 inspections normally conducted each year for food, tobacco, and medical products. About half of all the completed inspections (741) involve drugs and medical products. If one combines mission-critical and priority inspections, the totals come to 155 inspections of establishments producing human drugs, 80 for medical devices, and 63 for biologics; the largest portion of audits include more than 400 for clinical data and research sites.

One result is that 68 of more than 13,500 applications for new medical products had approvals delayed largely due to the agency’s inability to conduct inspections.

Growing backlog

The prospects for catching up are dim because the agency must address all those site visits missed this past year, while striving to deal with continued growth in its oversight responsibilities. FDA should inspect more than 23,000 establishments across all commodities in the current fiscal year (ends Sept. 30, 2021), the number expanded by those rolled over from last year. About 4000 of these audits cover establishments producing drugs, biologics, and other medical products. But even with a return to standard operations by mid-summer, the agency expects to conduct only 851 mission critical and priority site visits for medical products. If all travel restrictions are lifted and no other emergencies occur, FDA’s best-case scenario calculates that it might be able to conduct 1600 domestic inspections this year—about half of the to-do list.

Moreover, there’s always the possibility the situation could get worse—if new variants emerge, travel remains restricted, or FDA staff appears at risk in visiting manufacturing facilities. Then the agency will have to revert to utilizing alternatives to on-site visits, such as virtual inspections, sample testing, and reliance on reports from trusted foreign regulatory partners—all considered less effective than real-time inspections.

FDA’s continued focus on mission-critical and high-priority inspections in the coming months means that it will postpone most routine surveillance activity. Mission-critical inspections include important products previously involved in recalls or serious adverse events, plus preapproval audits for breakthrough therapies, regenerative medicines, treatments for serious conditions, and products related to COVID-19. The ongoing delays in inspections for lower-risk facilities means that for some time there will be wider intervals of time between inspections for sites subject to routine post-approval surveillance, as compared to emergency use authorizations, emergency situations, or critical medicines.

For the longer term, FDA looks to modernize its inspection program as part of a multi-year effort to transform data enterprise platforms and enhance cross-program interoperability. This IT modernization initiative will review approaches to regulatory oversight using next-generation assessment technologies, while also reviewing the need for potential legislative action to enhance regulatory oversight. A new agency-wide Inspectional Affairs Council will plan and coordinate inspection activities.

About the author

Jill Wechsler is BioPharm International's Washington editor.