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Republicans seek more information from FDA on its foreign drug inspection program
In a letter, members of the House Committee on Energy and Commerce discussed their analysis of FDA inspection outcomes in India and China from January 2014 to April 2024.
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Logo of US FDA. / Wikipedia
In a recent letter to the Food and Drug Administration (FDA) Commissioner Robert Califf, House Energy and Commerce Committee Chair Cathy McMorris Rodgers, Subcommittee on Health Chair Brett Guthrie, and Subcommittee on Oversight and Investigations Chair Morgan Griffith have requested additional information about the agency’s foreign drug inspection program in India and China.
In the letter, the Members outline the Committee’s analysis of FDA inspection outcomes in India and China from January 2014 to April 2024. The Committee limited its review to inspectors with 10 or more inspections in either China or India.
The Members noted that some FDA inspectors consistently found compliance issues during all or nearly all of their inspections, while others rarely reported any issues. Remarkably, two inspectors did not find a single compliance issue over the course of 24 combined inspections in India. Another inspector identified no compliance issues in 20 out of 23 inspections (85 percent) in China, yet found issues in almost half of domestic inspections during the same period.
“The results of this analysis were surprising, revealing tremendous variation in inspection outcomes,” they emphasized in a letter.
The large variations in inspection outcomes are troubling and warrant further investigation, it said. The Committee is concerned that these findings suggest significant differences in the skill, thoroughness, and competence of FDA inspectors.
Prior to the pandemic, media reports indicated that some FDA inspectors were overly lenient with foreign drug manufacturers that had serious compliance violations. Additionally, there were reports and concerns about foreign manufacturers attempting to bribe or improperly influence inspectors, the letter said.
The letter comes after Indian spice makers MDH and Everest came under the US FDA radar after Hong Kong halted sales of some of their products for allegedly containing pesticide ethylene oxide beyond permissible limits.
"The FDA is aware of the reports and is gathering additional information about the situation," an FDA spokesperson had told Reuters.
In April this year, Hong Kong suspended sales of three MDH spice blends and an Everest spice mix for fish curries. Singapore also ordered a recall of the Everest spice mix, citing high levels of ethylene oxide, which is unfit for human consumption and poses a cancer risk with long-term exposure.
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