FDA's drug manufacturing oversight lags as pandemic wears on

Two and a half years in, the COVID-19 pandemic continues to drag on the FDA’s oversight of drug manufacturing plants.

In fiscal year 2021, the FDA sent out 70% of follow-up letters to manufacturing facilities within 90 days of an inspection. Over that same stretch, the regulator completed 48% of regulatory actions for facilities in need of follow-up within six months of inspection closing, the agency said in a new report.

To put those stats in perspective, the agency in fiscal year 2020 sent 78% of classification letters within the 90-day time frame and knocked out 63% of regulatory actions required over a six-month span. And in 2019, it sent out 87% of letters and completed 74% of regulatory actions during those time frames.

The report hints at the FDA’s ongoing difficulty tackling inspection and oversight duties during the pandemic. As the virus has spread, evolved and settled in, the regulator has at several points had to pause site visits at home and abroad. Twice last year it signaled concerted efforts to get its oversight back on track.

An anonymous former FDA official told Stat the newly disclosed shortfalls represent “a pretty significant drop" and could have “real-world implications.”

Drug applications could be put on hold, drugmakers might have to seek out new suppliers and certain products could fall into shortage, the former official told Stat.

The FDA’s latest “Concept of Operations” report comes from the agency’s Center for Drug Evaluation and Research and the Office of Regulatory Affairs, which banded together in 2017 in pursuit of a more consistent, efficient and transparent regulatory approach for human drug facilities.

The FDA did not immediately reply to Fierce Pharma’s request for comment, nor did it provide an update on the number of surveillance inspections it completed in fiscal year 2021.

In an update to the agency’s inspection resiliency “roadmap” in November, the FDA said it had completed more than twice the number of domestic inspections it figured it could complete in fiscal year 2020 and 2021.

The update came after the regulator in March 2021 estimated that there were more than 15,000 domestic inspections that had been postponed because of COVID-19—a number that included drug, device and food plants.

Despite that win at home last fall, concerns have persisted over the FDA’s ability to knock out inspections of foreign drug manufacturing facilities, especially in countries like China and India.