With pandemic restrictions lifted, FDA restarts U.S. inspections and seeks to whittle its massive backlog

FDA Building 2
With a return to normal operations, the FDA can work on its backlog of inspections in the United States. In May the agency said it had more than 21,000 outstanding inspections due by the end of the fiscal year on September 30. (FDA)

With the easing of restrictions in the U.S., the FDA is free to attack its pandemic-induced backlog of site inspections.

During an educational industry conference hosted by the agency on Monday morning, acting FDA commissioner Janet Woodcock said that inspections in the U.S. have returned to normal.

"As of this month, we've begun transitioning back to standard operations for domestic inspections, while continuing to prioritize mission-critical work for foreign inspections," Woodcock said.

An agency spokesman confirmed that the FDA resumed domestic inspections on July 1. 

To catch up on last year’s backlog, which grew rapidly during the pandemic, the FDA said in May that it needed to complete 23,297 surveillance inspections in the fiscal year that ends on September 30. Of those outstanding inspections, 21,521 remained in the U.S. 

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While most of the lingering inspections covered sites that produce food products, delays have also hit the biopharma industry. Of the 857 outstanding inspections for human drugs as of May, the agency had 515 domestic inspections yet to complete and 342 overseas.

In all, 48 drug applications had been affected by site inspection delays, the FDA said.

At the outset of the pandemic, the FDA said it would halt domestic and foreign inspections. The agency made some exceptions, including for sites that produced COVID-19 countermeasures and breakthrough therapies. 

Among the drugmakers hit by the delays were Revance and Mallinckrodt, each with skin drugs that could have been ready for approvals if not for inspection dealys.

RELATED: FDA's inspection woes to grow if agency doesn't address COVID-19 backlog: GAO

But the case of Bristol Myers Squibb garnered the most attention in the biopharma industry last year. Delays on the CAR-T drug Breyanzi, in part stemming from pandemic restrictions, cost investors mightily as BMS couldn't get medicine approved by the end of 2020. Breyanzi's approval by the end of 2020 was one requirement in a multibillion-dollar contingent value right tied to the Celgene buyout.