Eli Lilly Sued by Whistleblower
A former employee of Eli Lilly is suing the company, claiming she was terminated after exposing issues with pharmaceutical manufacturing practices at one United States operation. Amrit Mula said that she had urged Eli Lilly officials to correct manufacturing issues, including some that affected its popular biologic drug Trulicty.
The US Justice Department began investigating the claims last year after Mula felt forced to publicize her story in response to a lack of effort to address the manufacturing issues. In 2019, an FDA inspection revealed serious violations at the Branchburg, New Jersey plant, where Lilly manufactures active pharmaceutical ingredients. Executives promised to address the concerns but also mentioned the problems did not impact drug quality or patient safety.
Drug inspectors found quality control issues at the pharmaceutical manufacturing plant, including data deletions and improper audits that led to an “Official Action Indicated” notice from the FDA, according to Reuters. This is the most severe level of violation issued by FDA inspectors.