US Gov. Office asks FDA to improve Foreign Inspection Program

As reported on several occasions, the FDA has reduced its inspection activities due to the pandemic. Internationally, almost no inspections have been carried out at all.

Already last year, US Congress Committee on Energy and Commerce had expressed concern about the backlog of inspections of pharmaceutical manufacturers and of applications for marketing authorisation. For the authors of a letter to the FDA, the strategy for resuming inspections and addressing the backlog that had developed remained unclear. Moreover, it was not clear how the delayed inspections would affect the processing of drug applications and their approvals.

In its Roundup of 4 January this year, the FDA announced that it was now adjusting its planned inspection activities to the developing COVID-19 pandemic and the spread of the Omicron variant. The agency has therefore postponed certain inspection activities again. As a result, the agency also postponed the scheduling of surveillance inspections abroad, which were supposed to begin in February 2022.

Now, the United States Government Accountability Office (GAO) has released a report to Congress entitled "FDA Should Take Additional Steps to Improve Its Foreign Inspection Program".

Interestingly, the GAO's concerns go back to before the pandemic. The GAO found problems in the FDA foreign inspection programme as early as 1998. Since then, the problems have intensified, in part because of the increase in manufacturing activities overseas. In March 2021, for example, the FDA was responsible for overseeing more than 4,000 foreign companies (both drug and drug substance manufacturers). In 2019 (before the pandemic), the FDA conducted just 600 foreign inspections; between March and October 2020, only three, and between October 2020 and April 2021, eighteen. This has further increased the backlog of inspections of foreign production sites, the GAO says.

Furthermore, the GAO criticises the conduct of inspections abroad. Investigators are often under time pressure and have to rely on on-site support.  And it is precisely for this purpose that FDA personnel are lacking on site (e.g. in the offices in India and China).

The GAO now defines three recommendations ("Recommendations for Executive Action ) for FDA:

• Ensure that FDA considers the practices identified by GAO when finalizing its plans for evaluating the effectiveness and efficiency of unannounced overseas inspections.
• Ensuring that FDA takes the identified practices into account when finalizing its plans for evaluating the costs and effects of using different types of translation services during foreign inspections.
• Ensuring that the FDA agency develops tailored strategies-including detailed implementation steps and timelines-focused on recruiting new investigators and developing and retaining existing investigators.