FDA's domestic inspection hold will continue until February
Amid a backlog of inspections, the FDA has announced that it will extend its pause of domestic inspections not considered mission-critical due to the outbreak of the Omicron variant.
While the agency will continue both foreign and domestic inspections deemed mission-critical, others will be paused through at least Feb. 4, and restart as soon as possible after that.
Previously planned foreign inspections will carry on as long as they’re in a country that has been cleared, and are within the CDC’s Level 1 or Level 2 Covid-19 travel recommendation — otherwise, they’ll be rescheduled. The FDA hopes to return to a regular cadence for foreign inspections in April.
Quietly in the start of January, the FDA announced that it paused inspections not considered mission-critical for “at least two weeks” to ensure the safety of FDA employees. Somewhat normal inspections had only just resumed in July. A November 2021 report noted that 52 new drug applications were delayed, in part due to the backlog.
“The agency will proceed with previously planned foreign surveillance inspections that have received country clearance and are within the CDC’s Level 1 or Level 2 Covid-19 travel recommendation; otherwise, the inspection will be rescheduled,” FDA spokesperson Michael Felberbaum said. “The FDA’s goal is to return to a regular cadence for foreign surveillance inspections in April.”
If foreign regulators have given the site the OK, particularly in Europe, the FDA reserves the right to make a decision based on local information. A shift to remote assessments of the facilities is the end goal, but much of the backlog is due to surveillance inspections, which must be done on-site.
The news comes days after a bill that would require the FDA to offer the same lead time to domestic companies as it does to foreign manufacturers was introduced by two Republican senators. Sens. Mike Braun (R-IN) and Joni Ernst (R-IA) have penned a bill called the Creating Efficiency in Foreign Inspections Act, in hopes of leveling the playing field and bringing more manufacturing to the country.
“This bill will put American producers on a level playing field with foreign competitors, help bring manufacturing back to the US, and reduce our reliance on communist China,” Ernst said in a press release.