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A Giant Indian Drugmaker Failed to Fix Safety Breaches. The FDA Let It Off the Hook Again and Again.
Sun Pharma, a major generic drug manufacturer, repeatedly failed to meet quality standards at its Indian factory, particularly concerning injectable drugs. Despite numerous FDA inspections revealing critical violations like contamination and disrepair, Sun consistently made promises of reform. For eight years, the FDA largely tolerated these broken promises, allowing an uninterrupted supply of Sun's drugs to the U.S. market. Documents obtained by ProPublica show the FDA’s leniency, even as they declared Sun’s products adulterated due to compromised quality and purity. The agency only banned shipments from the Halol factory in late 2022, but immediately granted exemptions for many drugs. Subsequent inspections in 2022 found practically identical deficiencies, with dirty equipment and impurities persisting. This practice of granting exemptions to prevent drug shortages, even from companies with repeated violations, has been applied to over 20 foreign factories since 2013. The FDA claims companies must conduct extra testing for exempted drugs, but their own records indicate some provided unreliable data. Concerns about Sun's manufacturing quality, including tampering with test results, were known among FDA inspectors. Despite thousands of adverse event reports related to Sun's drugs, the FDA has not shared specific details with prescribing doctors or patients, raising serious questions about consumer protection.