Washington, Three top US lawmakers have questioned the Food and Drug Administration's foreign drug inspection program in India and China.
In a letter to FDA Commissioner Robert Califf, lawmakers wrote Monday that the gap in inspection results appears to be just another example of institutional weaknesses and dysfunction in the FDA's foreign drug inspection program.
The letter dated June 21 was written by House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Health Subcommittee Chairman Brett Guthrie, and Oversight and Investigations Subcommittee Chairman Morgan Griffith. , following analysis of the results of FDA inspections in India and China from January 2014 to April 2024.
“The results of this analysis were surprising and revealed enormous variation in inspection results. Some FDA inspectors found compliance problems during all or nearly all of their inspections. Other inspectors rarely reported finding a single compliance problem. Two inspectors never found a single compliance issue in 24 combined inspections in India,” they wrote.
Another inspector found no compliance issues in 20 of 23 inspections (85 percent) in China, while finding compliance issues in nearly half of domestic inspections during the same period. These are unusual inspection results, 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 lawmakers wrote.
“In contrast, 16 FDA inspectors, with more than 325 collective inspections 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 results of 3 FDA inspectors with a professional reputation for rigor who also conducted at least 10 inspections in China or India during the period studied,” they wrote. .
These expert inspectors reported finding no compliance problems during inspections in China at a rate of only 6.7 to 11.4 percent and at a rate of zero to 9.5 percent in India, they said, adding that Such large variations in inspection results are concerning, and deserve further investigation. At a minimum, the Committee is concerned that these findings suggest large differences in the skill, thoroughness, and competence of FDA inspectors.
As such, lawmakers pushed for more information about the agency's foreign drug inspection program.
In a letter to FDA Commissioner Robert Califf, lawmakers wrote Monday that the gap in inspection results appears to be just another example of institutional weaknesses and dysfunction in the FDA's foreign drug inspection program.
The letter dated June 21 was written by House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Health Subcommittee Chairman Brett Guthrie, and Oversight and Investigations Subcommittee Chairman Morgan Griffith. , following analysis of the results of FDA inspections in India and China from January 2014 to April 2024.
“The results of this analysis were surprising and revealed enormous variation in inspection results. Some FDA inspectors found compliance problems during all or nearly all of their inspections. Other inspectors rarely reported finding a single compliance problem. Two inspectors never found a single compliance issue in 24 combined inspections in India,” they wrote.
Another inspector found no compliance issues in 20 of 23 inspections (85 percent) in China, while finding compliance issues in nearly half of domestic inspections during the same period. These are unusual inspection results, 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 lawmakers wrote.
“In contrast, 16 FDA inspectors, with more than 325 collective inspections 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 results of 3 FDA inspectors with a professional reputation for rigor who also conducted at least 10 inspections in China or India during the period studied,” they wrote. .
These expert inspectors reported finding no compliance problems during inspections in China at a rate of only 6.7 to 11.4 percent and at a rate of zero to 9.5 percent in India, they said, adding that Such large variations in inspection results are concerning, and deserve further investigation. At a minimum, the Committee is concerned that these findings suggest large differences in the skill, thoroughness, and competence of FDA inspectors.
As such, lawmakers pushed for more information about the agency's foreign drug inspection program.
