OIG report accuses FDA of not following policies for foreign drug inspections
A new report from the US Department of Health and Human Services’ Office of Inspector General accuses the FDA of not following its policies around foreign drug inspections, and recommends some improvements.
The OIG report, released on Thursday, found that the FDA has not always followed its policies and procedures for foreign for-cause drug inspections, and that the agency allegedly misplaced documents to prove its lead investigators completed their required training.
The OIG also accused the agency of failing to record certain information such as whether an inspection was announced, and lacking policies requiring supervisors to verify that lead investigators completed their training.
The FDA blamed limited resources and “unexpected events and complex circumstances,” according to the report. Agency officials told the OIG that due to multiple location moves, it had misplaced records showing that lead investigators met the training requirements.
The report notes that the FDA’s oversight is becoming more complicated as drugs that used to be manufactured in the US are going overseas. According to the OIG, 74 % of API manufacturers and 54% of finished goods manufacturers are now located outside the US. Though the agency started implementing some changes to the foreign inspection process in 2017, Congress has expressed concerns.
“We recommend that FDA identify and implement additional ways to improve the timeliness of its foreign for-cause drug inspection process. We also made other procedural recommendations that are listed in the report,” the report states.
According to the OIG, the FDA agreed with the recommendations and promised to work on improving the timeliness of its overall foreign inspection process. The agency also said it would implement a system to “better document and track investigators’ qualifications and certification.”
“FDA also stated that it is addressing ways to reduce the time spent writing and reviewing EIRs and that it is conducting a workload analysis for individuals responsible for determining final classification, issuing warning letters, and holding regulatory meetings,” the report said. However, no timeline was given.
Foreign inspections have always been a major topic for the FDA. Foreign drug facility inspections fell by about 10% from 2016 to 2018 as the FDA struggled to hire new inspectors. At the time, Republicans argued that the agency was not completing enough foreign drug inspections and that it couldn’t hire enough inspectors.
In March, a bill came forward that would require FDA to conduct a pilot program to increase the number of unannounced inspections of foreign drug facilities, which was a provision also included in the federal budget bill. The legislation would also issue a report to evaluate any differences between unannounced and announced inspections, barriers to conducting unannounced inspections, and challenges to evening the playing field for domestic and foreign drug inspections.