In a recent hearing before the House Subcommittee on Oversight and Investigations, a Government Accountability Office official reiterated the challenges faced by the Food and Drug Administration in overseeing foreign drug manufacturing facilities.

Mary Denigan-Macauley, director of health care at the GAO, indicated that her agency has long reported about FDA efforts to increase the number of foreign drug manufacturing establishments it inspects. Foreign establishment inspections rose markedly from fiscal year 1997 to a peak in FY 2016, and after experiencing decreases during FY 2016-18 inspections rose again in FY 2019. The GAO has noted that the postponement of inspections due to the COVID-19 pandemic led to a backlog of establishments never inspected or not inspected within five years, which the FDA has sought to address.

According to Denigan-Macauley, there are a number of challenges that are unique to conducting foreign inspections, including the fact that, while domestic inspections are almost always unannounced, the FDA generally pre-announces foreign inspections up to 12 weeks in advance, which may afford foreign establishments the opportunity to fix problems before the inspection. As a result, investigators may be less likely to see the true day-to-day operating environment of foreign establishments as compared to domestic establishments. The FDA has also relied on translators provided by the foreign establishments being inspected, which raises questions about the accuracy of the information collected by investigators.

In this regard, the GAO has reported that the FDA had planned on implementing pilot programs focused on evaluating the effect of conducting unannounced inspections and using independent translation services and recommended that the FDA incorporate leading practices into the design of both its unannounced inspection and translation pilot programs.

Another challenge highlighted by Denigan-Macauley at the hearing are persistent vacancies among FDA investigators available to conduct foreign inspections, although she did note that as of March 2023 the FDA had made progress implementing tailored strategies to ensure it has a sufficient foreign inspection workforce.

For more information on this and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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