With omicron on the prowl, FDA extends inspection pause into February

The pandemic continues to drag on the FDA’s inspection plans. Now, the regulator is prolonging an intermission that kicked off just before the new year and was pegged to conclude last week.

The extended pause applies to certain inspection activities as the FDA keeps tabs on the COVID-19 pandemic and the spread of omicron, the regulator said Friday. While the agency will continue to perform mission-critical inspections at home and abroad, it is drawing out the pause on domestic surveillance inspections through Feb. 4. The goal is to restart those activities “as soon as safely possible.”

As for oversight overseas, the FDA said it would carry on with previously planned foreign surveillance inspections that have received country clearance and are within the Centers for Disease Control and Prevention’s level 1 or level 2 COVID-19 travel recommendation. If those requirements aren’t met, the inspection will have to be rescheduled, the FDA said.

By April, the regulator says it hopes to “return to a regular cadence for foreign surveillance inspections.”

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The agency continues to leverage tools like remote assessments and import operations surveillance to help with its food and drug oversight.

Earlier this month, the FDA announced a pause on certain inspections through Jan. 19 as it worked “to ensure the safety of its employees and those of the firms it regulates” in the wake of the troubling coronavirus variant. The pause itself was initiated on Dec. 29, the FDA said at the time. 

Before the first omicron-fueled inspection pause, the FDA had been planning to overhaul its overseas oversight mission. But in announcing the temporary halt earlier this month, the FDA said it was “postponing the planning of prioritized surveillance foreign inspection assignments that were scheduled to begin in February 2022.”

Foreign inspections have been a pain point for the agency since before the COVID-19 pandemic, Mary Denigan-Macauley, director of healthcare at the Government Accountability Office (GAO), said last year in an interview.

Two big problems stem from overseas staffing vacancies and language barriers. The FDA in December told Fierce Pharma it was “actively working on these issues.” The agency cited a pilot program planned for 2022 that would strive to “enhance translator capabilities of foreign drug inspections” as well as the recruitment of “foreign cadre staff” who would be based in the U.S. but travel to foreign countries to conduct inspections.