Drugs

Committee Finds Troubling Foreign Inspection Issues

The House Energy and Commerce Committee is seeking additional inspection records from FDA after a recent committee analysis of the foreign drug inspection program found troubling issues. In looking at inspections in India and China from 1/2014 to 4/2024, the committee says its analysis revealed “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.”

In a 6/21 letter to FDA commissioner Robert Califf, the committee notes it found “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.” For example, it says 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%) in China while finding compliance issues with almost half of domestic inspections during the same period. By contrast, 16 FDA inspectors, with over 325 inspections collectively in India, found compliance issues during every inspection they conducted.”

The committee letter says staff also reviewed the inspection outcomes for three FDA inspectors known for their 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% and at a rate of zero to 9.5% in India,” it says. “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.”

The letter requests more inspection records from FDA so staff can continue their evaluation. For example, it asks for:

Records of all inspections conducted in India and China from January 2021 to April 2024 by FDA inspectors identified in an attached non-public document. The listed inspectors are those who have conducted at least 10 inspections in India or China and who reported no compliance issues in 70% or more of their inspections in India or in 50% or more of their inspections in China.
Copies of all FDA policy and guidance documents related to the conduct of foreign inspections, including any anti-bribery or gratuity training material, program integrity materials, and performance evaluation metrics for inspectors.
Copies of all FDA policy and guidance documents related to any data analytics used to evaluate foreign inspection outcomes and trends.

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