Three top American lawmakers have questioned the of the in and . In a letter to FDA commissioner Robert Califf, the lawmakers on Monday wrote that the difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA's foreign drug inspection programme. The letter dated June 21 was written by House Energy and Commerce committee chair Cathy McMorris Rodgers, subcommittee on health chair Brett Guthrie, and subcommittee on Oversight and Investigations Chair Morgan Griffith following the analysis of the outcomes 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 found 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 zero compliance issues in 20 out of 23 inspections (85 percent) in China while finding compliance issues in almost half of domestic inspections during the same period. These are unusual inspection outcomes, the opposite of what would be expected given the widely reported failures in and lack of adherence to current by drug manufacturing facilities in China and India, the lawmakers wrote.
"By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance is.