Eli Lilly has settled a whistleblower lawsuit that was filed by a former employee who was terminated for bringing poor manufacturing practices and data falsification to the company's attention. This alleged misconduct included issues with Eli Lilly’s major diabetes drug.
The former Eli Lilly human resources officer, Amrit Mula, alleged that she had repeatedly urged higher-ups at a New Jersey plant to fix issues with multiple drugs including the biologic drug Trulicity that treats type 2 diabetes. Mula says that after making these deficiencies known, Eli Lilly terminated her. In its defense, Eli Lilly has stated that Amrit Mula is a non-scientist whose allegations are incorrect.
The facility Mula reported has received scrutiny from the FDA for over 4 years. The facility came to the FDA’s attention after inspectors found that quality control data had been systematically deleted and proper auditing had not occurred. In addition to producing Trulicity, the facility also manufactured multiple cancer medications and a treatment for COVID-19. Upon a return inspection, inspectors found that when batches of drugs had been destroyed due to manufacturing or quality control errors, the causes were not being properly assessed by Eli Lilly to prevent the problem from recurring. Additionally, the U.S. Department of Justice has launched a criminal investigation into the company after Reuters published an article detailing some of Mula’s allegations.
Eli Lilly has stated that it is...
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