While the FDA has made efforts to recruit and retain drug investigators who conduct inspections in foreign countries, the agency’s capacity to conduct such inspections remains challenged, according to the updated High Risk List released this week by the Government Accountability Office.
Despite implementing a workgroup to address long-standing challenges recruiting investigators to work in its offices in China and India, the GAO found that the FDA “continues to face significant vacancies among investigators critical to ensuring the safety of the drug supply.”
Specifically, the congressional watchdog warned that the FDA “faces vacancies among those who inspect entities conducting clinical research as well as those who inspect drug manufacturers.” As of June 2024, the GAO revealed there are 51 vacancies of FDA drug manufacturing investigators.
After talking to agency officials, the GAO revealed that investigator positions have the highest levels of attrition at the FDA, which has “hindered its ability to resume inspections at rates comparable to the rate prior to the COVID-19 pandemic.”
While the FDA in fiscal year 2024 began its planned increase of routine inspections of drug manufacturers for the first time since the pandemic, the GAO said the agency “needs to do more to define its oversight approaches and evaluate them to ensure progress.”
To fill the significant investigator vacancies and help increase the number of inspections, the GAO recommended that the FDA develop and implement plans to address the root causes of attrition for investigators who inspect drug manufacturers.
The FDA is conducting a pilot program to evaluate the effectiveness and efficiency of unannounced inspections to decide if this approach should be applied more broadly, according to the GAO. As of January 2025, the agency is in the process of evaluating interim results of the unannounced inspection pilot.
In February 2024, Mary Denigan-Macauley, the GAO’s director of healthcare, testified before a congressional subcommittee that the FDA continues to face “persistent challenges” overseeing foreign drug manufacturing. That same month, the agency said it planned to increase inspections of Indian manufacturing facilities.
However, in a June 2024 letter, the chairs of the House Energy and Commerce Committee and two subcommittees pressed the FDA for more information after the members of Congress discovered “tremendous variation in inspection outcomes” in the agency’s foreign drug inspection program.
The congressional analysis of FDA inspections in India and China, from January 2014 to April 2024, focused on inspectors with 10 or more inspections in either Asian country. While some of the agency’s inspectors found compliance issues during all or nearly all of their inspections, other inspectors rarely reported finding a single compliance issue.
“These are unusual inspection outcomes, the opposite of what would be expected given the widely reported failures in quality control and lack of adherence to current good manufacturing techniques by drug manufacturing facilities in China and India,” the chairs of the committee and subcommittees said in their letter to the FDA.