Three prominent American lawmakers have raised concerns about the Food and Drug Administration’s (FDA) foreign drug inspection program in India and China.
In a letter to FDA Commissioner Robert Califf on Monday (24), the lawmakers expressed their worries about the differences in inspection results. They believe these differences highlight ongoing issues and inefficiencies within FDA’s foreign drug inspection program.
The letter dated June 21, was signed by Cathy McMorris Rodgers, Chair of the House Energy and Commerce Committee, Brett Guthrie, Chair of Subcommittee on Health, and Morgan Griffith, Chair of the subcommittee on Oversight and Investigations. This letter follows an analysis of FDA inspections in India and China from January 2014 to April 2024.
“The results of this analysis were surprising, revealing tremendous variation in inspection outcomes. Some FDA inspectors found compliance issues during all or almost all of their inspections. Other inspectors rarely reported finding a single compliance issue. Two inspectors never found a single compliance issue throughout a combined 24 inspections in India,” they wrote.
Another inspector found no compliance issues in 20 out of 23 inspections (85 per cent) in China, while finding compliance issues in nearly half of domestic inspections during the same period.
According to the lawmakers, these are unusual inspection outcomes, opposite to what would be expected given the widely reported quality control failures and lack of adherence to current goof manufacturing practices by drug manufacturing facilities in China and India.
“By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted. As a measure of what a pattern of rigorous inspections should look like, the Committee reviewed the inspection outcomes for 3 FDA inspectors with a professional reputation for thoroughness who also had at least 10 inspections in China or India during the studied period,” they wrote.
These expert inspectors reported finding no compliance issues during inspections in China at a rate of only 6.7 to 11.4 per cent and at a rate of zero to 9.5 per cent in India, they said, adding that such large variations in inspection outcomes are troubling, and they merit further investigation.
At a minimum, the Committee is concerned that these findings suggest vast differences in the skill, thoroughness, and competence of FDA inspectors. As such, the lawmakers pressed for more information regarding the agency’s foreign drug inspection programme.
