Impact of COVID-19 on FDA Inspections
The COVID-19 pandemic profoundly disrupted the FDA’s inspection capabilities, prompting concerns raised by the U.S. Congress regarding the backlog in assessing pharmaceutical manufacturing facilities[i]. This tumultuous period led to a significant reduction in annual inspections, plummeting from the usual 1000 to 821 inspections within a year and delaying over 15,000 inspections across the United States[ii].
Figure 1: Number of Food and Drug Administration (FDA) monthly drug quality assurance inspections by world region, 2012–22 (iii)
Shift in Inspection Paradigm
Comparative analysis between FY 2020 and FY 2021 reveals a marked departure from the traditional reliance on onsite inspections for the issuance of warnings and alerts[iv]. Despite encountering workforce challenges such as staff shortages and potential burnout, the FDA has remained committed to a forward-looking strategy. Evidenced through initiatives like the Technology and Data Modernization Action Plans, the agency is focused on modernizing its inspection programs and incorporating cutting-edge technologies for data collection, review, and analysis to optimize public health outcomes[v].
Implications for the Pharmaceutical Industry
These adaptive measures carry profound implications for the pharmaceutical industry. They signal a potential transformation in the paradigm of drug approval processes, emphasizing a more data-centric and adaptable approach[vi]. The industry might witness an increased emphasis on comprehensive data analysis, innovative inspection methodologies, and remote assessments, potentially streamlining and modernizing the drug approval pipeline while ensuring robust safety and efficacy evaluations[vii].
Shaping Future Regulatory Practices
The adaptations made by the FDA during this tumultuous period are poised to significantly influence future regulatory practices. They underscore the potential for more flexible, technology-driven inspection approaches, setting a precedent for a more adaptable regulatory framework. Future regulatory strategies may prioritize data integrity, technological integration, and innovative assessment methodologies, ultimately ensuring greater agility in responding to unforeseen challenges while maintaining stringent safety standards.
Outlook, updated in 2023
In 2023, the impact of the COVID-19 pandemic on FDA inspections is evident. Data from 2012 to 2022 revealed a sharp decline in both foreign and domestic inspections during the pandemic’s peak in 2020. Even by 2022, inspection rates remained significantly below pre-pandemic levels, dropping by 79% for foreign inspections and 35% for domestic ones compared to 2019. Interestingly, despite reduced inspections, there was no corresponding decrease in drug manufacturing or imports, indicating the industry’s resilience.
Surprisingly, the resources allocated per inspection surged during this period despite the FDA’s overall budget and staffing remaining steady. Equally striking was the substantial rise in citations issued.
These findings underscore a critical need for innovative and reliable methods beyond traditional inspections to ensure drug safety. Regulatory bodies must adapt to these challenges, emphasizing the urgency of exploring alternative approaches to maintain rigorous safety standards in drug manufacturing. This is essential for preserving public trust and confidence in pharmaceutical products amid evolving global circumstances.
KVALITO is a strategic partner delivering global quality and compliance services to its network of regulated clients in healthcare.
KVALITO serves its clients with successful audits & assessments, remote audits, and health authority inspections globally. Visit us at www.kvalito.ch to find out more and feel free to send us an email at contact@kvalito.ch
[i] Total number of inspections completed in the month FDA https://www.accessdata.fda.gov/scripts/fdatrack/view/track.cfm?program=oip&id=OIP-Number-of-inspections-completed-in-country-by-commodity
[ii] https://www.gmp-compliance.org/gmp-news/fda-report-on-impact-of-pandemic-on-inspections
[iii]https://www.healthaffairs.org/doi/10.1377/hlthaff.2023.00686
[iv]Francis Godwin at Regulatory Education for Industry (REdI): Pharmaceutical Quality Symposium
October 26 & 27, 2021 https://sbiaevents.com/pqs2021/#virtual
[v]GAO-12-409T, COVID-19: FDA’s Future Inspection Plans Need to Address Issues Presented by COVID-19 Backlog https://www.gao.gov/assets/gao-21-409t.pdf) 9-10
Sidley Austin LLP: FDA’s COVID-19 Facility Inspection Backlog: Likely Re-inspection Delays Emphasize Importance of Facility Readiness: https://www.sidley.com/en/insights/newsupdates/2021/04/fdas-covid19-facility-inspection-backlog-likely-reinspection
https://www.fda.gov/media/148197/download
