Three lawmakers from E&C Republicans have written a letter to Robert Califf, FDA Commissioner, stating the FDA’s foreign drug inspection programme to be dysfunctional and the difference in their inspection outcomes is an example of institutional weakness.
The letter dated June 21, 2024, written by Cathy McMorris Rodgers, House Energy and Commerce Committee Chair, Brett Guthrie, Chair Subcommittee on Health Chair, and Morgan Griffith, Subcommittee on Oversight and Investigations Chair, is pressing for more information regarding the agency’s foreign drug inspection programme.
The letter continues the Committee’s investigation into FDA inspection practices, which include a July 18, 2023, letter, a December 13, 2023, letter, and a February 6, 2024, oversight hearing at which the FDA declined to make an official available to testify.
Background
In the letter, the Members discuss the Committee’s analysis of FDA inspection outcomes in India and China from January 2014 to April 2024, limiting its review to inspectors with ten or more inspections in either China or India.
Excerpt of the analysis:
“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 over the course of a combined 24 inspections in India. Another inspector found zero compliance issues in 20 out of 23 inspections (85 per cent) in China while finding compliance issues with 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 quality control and lack of adherence to current good manufacturing techniques 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 professional reputations for thoroughness who also had at least 10 inspections in China or India during the studied time period. 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.”
Key letter excerpts:
“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. The difference in inspection outcomes appears to be just another example of institutional weaknesses and dysfunction in the FDA’s foreign drug inspection program. Prior to the pandemic, media reporting found that some FDA inspectors took an inappropriately lenient approach with foreign drug manufacturers with serious compliance violations. There were also reports of, and concerns about, foreign manufacturers attempting to bribe or improperly influence inspectors. The Committee is seriously evaluating the disturbing possibility that some of the variation in inspection outcomes could be the result of bribery or fraud.”