GAO Recommends Overhauling FDA Foreign Inspection Program

GAO Recommends Overhauling FDA Foreign Inspection Program

March 29th, 2022 // 1:52 pm @

Last month, the Government Accountability Office or GAO raised concerns about the FDA foreign inspection program for pharmaceuticals, saying the program should be revamped. The GAO report comes amind FDA’s challenges in doing foreign cgmp inspections during the COVID era.

In 2020 when the pandemic began, FDA stopped most foreign inspections temporarily. Although it planned to start the inspections again in February 2022, those plans were affected as the omicron variant began to spread. FDA announced earlier this year it will re-start foreign surveillance audits that have country clearance and have been approved by the US government for travel. FDA expects it will start foreign cGMP inspections in April 2022.

However, the GAO has raised concerns about the FDA foreign inspection program that predate the COVID-19 pandemic. GAO has noted problems with the program going back as far as 1998. Issues have gotten worse since more pharmaceuticals are produced overseas than 20 years ago.

In March 2021, FDA was charged with overseeing at least 4000 foreign manufacturing facilities that produce drugs for the US market. About 73% of overseas facilities make APIs and 52% make finished drugs.

FDA did 600 foreign audits in 2019, which dropped to only three between March and October 2020. There were only 18 high-priority foreign audits between October 2020 and April 2021. FDA has started to improve processes to determine with foreign facilities should be inspected. However, there is a long inspection backlog from the COVID-19 pandemic inspection pause.

FDA has additional problems when doing FDA audits overseas, GAO reports. Inspectors work on tight timeframes and audits are usually announced ahead of time. Inspectors also usually rely on drug company staff on site for help with translating.

Worker recruitment and retention is also an issue, with eight of 20 drug auditor roles for foreign drug manufacturing facilities vacant. Also, five of 15 inspector roles in China and India were vacant as of the end of 2021.

FDA still has not given a timeline for solving foreign inspection problems, and pilots to review the effects of unannounced audits and using third-party translators have been delayed by COVID.

GAO recommended in their report that a pilot program be started for surprise foreign inspections; starting a pilot program using different independent translators for foreign audits, and using tailored methods to recruit and retain FDA inspectors.

GAO wrote that maintaining a large and fully-staffed FDA auditor team is important as the agency will have a backlog of drug inspections for several years due to the pandemic.

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