Drug Safety: FDA Has Faced Persistent Challenges Overseeing Foreign Drug Manufacturing

What GAO Found

Over the years, GAO has reported on efforts by the Food and Drug Administration (FDA) to improve its oversight of foreign drug manufacturing establishments. FDA inspected a relatively small number of foreign establishments in fiscal year 1997 but significantly increased these numbers over the next two decades, with a peak in fiscal year 2016. However, beginning in March 2020, FDA postponed most inspections because of the COVID-19 pandemic.

During the time inspections were paused, FDA used alternative inspection tools to maintain oversight of drug manufacturing quality. These tools included relying on inspections conducted by foreign regulators and requesting and reviewing records and other information. The postponement of inspections led to a backlog of establishments never inspected or not inspected by FDA within 5 years—categories for which FDA considers inspections mandatory. GAO reported that this backlog could both extend the interval between inspections and reduce the resources FDA has available for other high-priority inspections.

Since 2007, GAO also has reported on unique challenges to conducting foreign inspections that can raise questions about their equivalence to domestic inspections. For example, in January 2022, GAO reported that, while domestic inspections have almost always been unannounced, FDA's practice of generally preannouncing foreign inspections up to 12 weeks in advance may have given 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. Further, FDA has relied on translators provided by the foreign establishments being inspected, which investigators noted can raise questions about the accuracy of information FDA investigators collect.

Vacancies among investigators available to conduct foreign inspections represent another challenge GAO identified in multiple reports. In January 2022, GAO reported that FDA had persistent vacancies among staff who specialize in foreign inspections. This included vacancies among U.S.-based staff who conduct foreign inspections and among staff in FDA's foreign offices located in China and India.

Why GAO Did This Study

FDA is responsible for ensuring the safety and effectiveness of all drugs marketed in the U.S., regardless of where they are produced. Globalization and the COVID-19 pandemic have complicated FDA's oversight of the more than 4,800 establishments manufacturing drugs for the U.S. market. FDA reported that 58 percent of these establishments were located overseas as of October 2022. GAO has had long-standing concerns about FDA's ability to oversee the increasingly global drug supply chain, an issue highlighted in our High-Risk Series since 2009. A critical element in FDA's oversight of overseas manufacturing is its inspection of foreign manufacturing establishments.

This statement discusses findings related to FDA's foreign drug inspection program that GAO has reported on over two decades, including findings that GAO previously reported in January 2022 and in its April 2023 High-Risk Series. This statement provides observations on FDA's inspections of foreign drug manufacturers, challenges unique to conducting foreign inspections, and FDA's foreign inspection workforce. For GAO's prior work, it analyzed FDA inspection and workforce data, interviewed FDA staff—including drug investigators who conduct foreign inspections—and reviewed agency documents. This statement also includes updates on the status of agency efforts to address relevant recommendations that GAO previously identified.