Indianapolis-headquartered pharmaceutical company Eli Lilly & Co is facing trouble at home after employees accused a factory executive of altering documents regarding the plant producing the firm’s COVID-19 antibody. The documents are related to regulatory requirements mandated by the government and the executive is said to have downplayed some quality control issues that the plant was facing.
The issue was revealed by an unknown source to Reuters. Employees filed an unsigned report on April 8 with the company through a confidential complaint system, detailing the actions of the executive. The Branchburg plant in New Jersey, which is producing the COVID antibody, was already under investigation by the U.S. Food and Drug Administration (FDA).
A top executive from the plant, Lydia Wible, who is named in the complaint, is said to have rewritten findings made by the company’s internal team of technical experts to make the conclusions favorable to the firm. The findings involved the use of bamlanivimab, a coronavirus antibody treatment that had been approved for emergency use by the FDA, which the government agency later revoked. The drug is used in COVID-19 patients who face a high risk of severe illness.
“The source familiar with the matter said the group that submitted the complaint comprises more than 10 employees, including managers. The source claimed that many of the staffers had seen the relevant documents both before and after they were altered. The complaint did not specify what alterations the employees believed were made to the documents but said Wible ‘rewrites factual data provided by subject matter experts to formulate responses she feels are more beneficial.’ It is not clear whether any of the documents have been submitted to the FDA,” states the Reuters report.
The company admitted that it has received the employee complaint regarding the alteration conducted at the Branchburg plant and stated that an investigation is currently being conducted by a third party due to which the firm does not wish to reveal anything at present. Within the past two months, the Branchburg plant hasn’t shipped any new batches of bamlanivimab. The company stated that it will meet its production commitments.
In March, Reuters had published a report that detailed problems in the manufacture of several of Lilly’s drugs. Emails of company executives from 2018 apparently showed that the company did not even have internally mandated quality assurance documents for one of its bestselling products Trulicity. A drug used in the treatment of type 2 diabetes, Trulicity had generated sales of about $4 billion for the company in 2019.
An employee at the Branchburg plant, identified as Mula, had constantly asked her superiors about several issues plaguing the plant, including destruction and falsification of records. Her inquiries were ignored, blocked, and downplayed. Mula was eventually terminated from the plant where she worked for almost 15 years; she told Reuters that she was just doing her job.
Kathryn Beiser, a spokeswoman for Lilly, stated that the company welcomes feedback from employees and had put in place “rigorous” quality control systems. “[Lilly has] long-standing policies and procedures that enable – and encourage – individuals to come forward with information about any potential issues or concerns without fear of retribution… We are continuously strengthening and reinforcing a culture where our employees can be proud of our work, so in turn, doctors and patients can trust Lilly’s products have been ethically, properly, and safely manufactured,” Beiser had said in a statement. However, she refused to address issues raised by Mula.
In April, the FDA revoked emergency use authorization granted to bamlanivimab. The authorization was revoked at the request of the company which cited COVID-19 variant issues in the United States. The variants are apparently resistant to bamlanivimab when the drug is used alone, resulting in a high risk while treating COVID-19 patients. As such, it was determined that the benefit of administering bamlanivimab alone for COVID-19 treatment no longer outweighed the risk of its emergency use.
“While the risk-benefit assessment for using bamlanivimab alone is no longer favorable due to the increased frequency of resistant variants, other monoclonal antibody therapies authorized for emergency use remain appropriate treatment choices when used in accordance with the authorized labeling and can help keep high-risk patients with Covid-19 out of the hospital,” Patrizia Cavazzoni, Director of FDA Center for Drug Evaluation and Research (CDER), had said in a statement.