Eli Lilly Sued by Whistleblower for Pharmaceutical Manufacturing Issue

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.

Responding to the recent lawsuit, Lilly officials said they would continue cooperating with the Department of Justice and FDA.

For reference, in 2009, Eli Lilly agreed to pay the largest individual corporate criminal fine in history at that point, amounting to $1.415 billion for the off-label promotion of its drug Zyprexa. More recently, the company settled a sexual discrimination lawsuit out of court after a lobbyist sued the company, alleging mistreatment.

Eli Lilly’s efforts to manufacture COVID-19 antibodies were ramped up at the Branchburg plant around the same time that FDA inspectors announced the quality issues they found there. Later, Lilly chose to cease the manufacture of the antibody bamlanivimab as variants emerged that evaded its efficacy.

It was also reported that components of Eli Lilly’s blockbuster diabetes drug — Trulicity — were manufactured at the same plant.

Trulicty has long been Lilly’s cash cow, bringing in $3.28 billion in gross spending in 2020. Eli Lilly has also precipitously increased the drug’s price since its release, raising it by 5% at the beginning of the pandemic alone.

Eli Lilly has sought to expand its reach in the US diabetes market in several instances as companies invent biosimilars to compete with Trulicty. In May, the company received FDA approval for an injectable type 2 diabetes treatment called Mounjaro. Lilly also sells non-branded insulin injections at a reduced price. And last year, the company acquired Protomer Technologies which specialized in type 1 diabetes treatments.