The Government Accountability Office (GAO), the congressional watchdog, has trained its sights on regulatory oversight of the global supply chain over the past 10 years. As the subject is on the GAO’s high risk list, the US Food and Drug Administration (FDA) has been the focus of a series of probes by the watchdog.
Earlier this month, the GAO published the findings of its latest assessment of the US FDA’s ability to oversee the global supply chain. The assessment raised some concerns.
From 2012 to 2016, the FDA increased its annual number of inspections of foreign facilities from 625 to 1,035. The rise followed a GAO recommendation that the US FDA inspect domestic and foreign sites at a comparable frequency.
However, the new report shows the trend reversed after 2016, falling by around 10% to 935 over two years. The GAO said FDA officials attributed the trend, in part, to “vacancies among investigators available to conduct inspections.” That problem may have intensified since 2018.
Staff at the US FDA Office of Regulatory Affairs (ORA) conducted around three-quarters of overseas inspections carried out by the agency in 2018. In June, the ORA had 190 investigators eligible to carry out foreign inspections. By November, the “the agency had an additional 58 vacancies in this group,” according to the GAO.
FDA officials pointed to a range of issues to explain the number of vacancies.
The GAO wrote, “FDA officials attributed the vacancies to multiple factors: investigator retirements, investigator movement to other parts of FDA, and the need to hire to additional investigator positions using generic drug user fees. Officials also said that a reorganization within ORA led to a reduced number of investigators who conduct drug manufacturing establishment inspections.”
It will take the FDA some time to recover from the staff shortages. The US FDA recently filled some vacancies but new investigators typically only start visiting foreign facilities after they have been at the agency for two to three years, suggesting there will be a lag between the appointments and any affect on the number of inspections.
Moves within the ORA could accelerate the process. Members of a small group within the ORA that is focused on foreign inspections conduct a disproportionate number of assessments, visiting 16 to 18 overseas sites a year compared to the three to six of their experienced colleagues in other groups.
The dedicated foreign inspection group shrank from 20 investigators in 2016 to 12 as of last month. To rebuild the team, the US FDA is trying to transfer people from the broader ORA group but there are doubts about whether all 20 slots will be filled.