GAO to FDA: Address foreign inspection backlog

The U.S. Government Accountability Office is asking the FDA to establish a plan to mitigate its foreign facility inspection backlog. In a new report, the GAO also asked the agency to develop new strategies to increase the recruitment of foreign investigators. 

The GAO is saying that in order to get things back on track the FDA must take three major steps. The agency must incorporate a pilot program to track the effectiveness of unannounced foreign inspections; the pilot program should evaluate the costs of using different translation services during foreign inspections; and the agency must develop a solid plan to attract and retain investigators on the foreign inspections team.

The FDA's backlog on facility inspections is long-standing, and the issue has been furthered by the pandemic. Between March and October of 2020, the FDA only conducted three foreign inspections, compared to more than 600 during the same time frame the previous year, according to the GAO. From October 2020 to April 2021, the agency inspected only 18 foreign facilities, most of which took place in China, the office said.

It’s not just the pandemic making these foreign inspections problematic, according to the GAO. Inspections are generally pre-announced and many FDA inspectors rely on translation services when conducting their investigations. The translation services typically come from the facility being inspected, raising potential questions about the quality of information being received. 

Staff shortages have also continued to complicate the inspectional process. The GAO found agency data that showed eight of 20 positions were vacant among FDA investigators that solely focus on foreign inspections and that five of 15 drug investigator positions were vacant in India and China.