An Inspector Calls?

The US Government Accountability Office (GAO) has aired concerns about the FDA’s ability to oversee pharma’s increasingly global supply chains since 2009, but the challenges have been further intensified by the backlog caused by the pandemic. From March 2020 to the end of the fiscal year, only three inspections were conducted. Instead, the FDA is using alternative tools and approaches to oversee drug manufacturing quality, including inspections conducted by foreign regulators, requesting and reviewing records and other information, and sampling and testing drugs. But these efforts are not equivalent to a full FDA inspection, according to the GAO.

The GAO has issued a report discussing the number of FDA foreign inspections; the FDA’s response to the pandemic and impact on inspections; and persistent foreign inspection challenges that have been an issue for years (1).

As of February 2021, the FDA has resumed some foreign inspections but no date has been set for resuming routine foreign surveillance inspections in all countries. Clearly, if inspections continue to be postponed, the backlog can only grow. The GAO has recommended that the FDA develops inspection plans for future fiscal years that identify, analyze, and respond to the issues presented by the backlog. But even prior to COVID-19, the FDA faced challenges in conducting foreign inspections, including inspection staff vacancies, preannouncing inspections (which could allow companies to cover up problems), and translation barriers. 

“Over the years since we first examined this issue, FDA has made significant changes to adapt to the globalization of the pharmaceutical supply chain and has greatly increased the number of inspections it conducts of foreign establishments,” the GAO report states. “However, we found in December 2019 that the agency faced many of the same challenges overseeing foreign establishments that we identified over the last two decades. Subsequently, the outbreak of COVID-19 has added a layer of complexity. Therefore, it will be important for FDA to utilize lessons that it has learned during the COVID-19 pandemic to improve its foreign drug inspection program, including efforts to identify alternative mechanisms to satisfy foreign inspection requirements and plans to address its growing backlog of inspections.”