US Lawmakers Challenge FDA's Foreign Drug Inspection Inconsistencies

Three prominent American lawmakers have raised concerns about the inconsistencies in the FDA's foreign drug inspection outcomes in India and China. They highlighted significant variations, suggesting a need for further investigation into the agency’s inspection program. The inquiry aims to address potential disparities in the skill and thoroughness of inspectors.

Three prominent American lawmakers are challenging the credibility of the Food and Drug Administration's (FDA) foreign drug inspection program, targeting its operations in India and China.

In a letter addressed to FDA Commissioner Robert Califf, the lawmakers pointed out the glaring discrepancies in the outcomes of inspections conducted between January 2014 and April 2024. They described this inconsistency as indicative of institutional flaws within the FDA's inspection processes.

The legislators, including House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith, are calling for a thorough review into the agency's methodology. Their findings suggest concerning variations in inspector competence and thoroughness, which they argue demand immediate attention.

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