As FDA resumes foreign inspections, GAO recommends revamping the program

Regulatory NewsRegulatory News | 08 February 2022 | By

In a report published Monday, the Government Accountability Office (GAO) raises questions about the US Food and Drug Administration’s (FDA) foreign inspections program for drugs and says the program is long due for an overhaul. The report comes amid the agency’s ongoing challenges in conducting foreign inspections due to the COVID-19 pandemic.
 
Early in the pandemic, FDA paused most foreign inspections, and though it had planned to resume planning those inspections in February 2022, those plans were impacted by the rise of the omicron variant. The agency recently announced that it will proceed with previously planned foreign surveillance inspections that have received country clearance and meet federal travel recommendations, and that it plans to begin conducting prioritized foreign inspections in April. (RELATED: FDA to resume routine domestic surveillance inspections next week, Regulatory Focus 4 February 2022)
 
However, GAO’s concerns about the agency’s foreign inspections program predate the pandemic. GAO identified problems in FDA’s foreign inspection program as far back as 1998, the report to Congressional requesters states, and issues have compounded as manufacturing of drug products has increased overseas. In March 2021, FDA was responsible for overseeing more than 4,000 foreign entities manufacturing drugs for the United States, with 73% foreign entities manufacturing active pharmaceutical ingredients and 52% manufacturing finished drugs. FDA conducted 600 foreign inspections in 2019, which decreased to just 3 inspections between March and October 2020 and 18 “high-priority” foreign inspections between October 2020 and April 2021. Although FDA has begun to improve on its process for identifying which foreign establishments are subject to inspection, inspection backlogs for foreign manufacturing entities has grown as a result of the COVID-19 pandemic, GAO said.
 
In addition to increased oversight and a decrease in number of inspections conducted, FDA’s program has other problems when conducting inspections overseas, GAO wrote in their report. Investigators often are under “constrained time frames” when working internationally, inspections are usually preannounced, and inspectors tend to rely on staff on-site for translation help. Workforce recruitment and retention is also an ongoing issue, with 8 of 20 foreign drug investigator roles and 5 of 15 drug investigator roles in China and India offices vacant as of November 2021.
 
“While drugs manufactured overseas for the US market must meet the same requirements as those manufactured in the US, these unique challenges raise questions about the equivalence of foreign to domestic inspections,” GAO wrote.  
 
Although FDA has started to examine these issues, the agency has not outlined a plan or timeframe for implementing a solution to these problems, and efforts to launch pilot programs examining the impacts of unannounced inspections and using independent translators have been delayed by the pandemic.
 
GAO provided three recommendations to FDA: use leading practices to start a pilot program for unannounced foreign inspections, develop a pilot program to use different types of independent translators for foreign manufacturing inspections, and use “tailored strategies—including detailing implementation steps and time frames—focused on recruiting new and developing and retaining current investigators to specialize in conducting foreign drug inspections.”
 
“Maintaining a robust investigator workforce is particularly important as FDA will likely continue to face a backlog of surveillance inspections in future years in light of the COVID-19 pandemic,” GAO wrote.
 
For its part, Department of Health & Human Services (HHS) concurred with GAO’s recommendations to improve FDA’s foreign manufacturing inspection program. In its written comments to GAO responding to the recommendations, HHS said a pilot program is being developed to test a system for unannounced inspections in India and China scheduled for “early 2022.” HHS also said a pilot program in China using translators provided by the US Department of State will be developed, but avoided describing a specific timeline for implementation, citing concerns about potential future COVID-19 outbreaks and travel restrictions.
 
Regarding workforce recruitment and retention, HHS said the FDA is “reviewing its current hiring and retention processes and considering our key principles for effective strategic workforce planning in order to develop detailed strategies focused on recruiting new and retaining the current foreign drug investigator workforce.” Other strategies, such as a focus on recruiting bilingual drug investigators, is also being evaluated by FDA, HHS said.
 
GAO: FDA Should Take Additional Steps to Improve Its Foreign Inspection Program

 

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