Califf Pressed by House Republicans for Answers on Foreign Inspection Irregularities

Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers.

In a six-page letter sent to FDA Commissioner Robert Califf on June 24, Committee Chair Cathy McMorris Rodgers (R-Wash.), Subcommittee on Health Chair Brett Guthrie (R-Ky.), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-Va.) wrote that their deep dive into 10 years of FDA’s foreign inspections unearthed “tremendous variation in inspection outcomes,” depending on the inspector and the country they were in.

For instance, they said, the analysis showed that some FDA inspectors found compliance issues during all or almost all of their inspections, while others 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, and another inspector found no compliance issues in 20 out of 23 inspections in China while finding compliance issues with almost half of domestic inspections during the same period.

Read the letter here.

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