U.S. lawmakers have intensified their scrutiny of the FDA’s foreign inspection program, particularly for companies based in China and India. Members of the Energy and Commerce Select Committee have penned a letter to FDA Commissioner Robert Califf, expressing serious concerns over significant variations in inspection outcomes that they believe raise questions about the validity of these inspections.
The correspondence follows an investigation by the Committee into the FDA’s inspection outcomes from January 2014 to April 2024, focusing on inspectors with ten or more inspections in China or India. The letter highlights a stark disparity in findings, with some FDA inspectors identifying compliance issues in nearly all of their inspections, while others found almost no issues across multiple companies. The letter points out that one inspector in China found zero compliance issues in 20 out of 23 inspections (85%), contrasting with a nearly 50% compliance issue rate in domestic inspections during the same period. In contrast, three FDA inspectors known for their thoroughness reported finding no compliance issues in China at a rate of only 6.7% to 11.4% and in India at a rate of 0% to 9.5% during the studied period.
The letter’s authors caution that these discrepancies suggest systemic weaknesses in the FDA’s foreign inspection program and raise the possibility of bribery or fraud. The committee is thus demanding that the FDA conduct a comprehensive review of its foreign inspection procedures and share these with the committee. They are also asking the FDA to explain why the number of warning letters for Chinese and Indian firms has decreased post-COVID-19 pandemic.- Flcube.com
