Lilly said it is cooperating fully with the DOJ and is in the process of conducting its own investigation into the allegations made against the company.
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More than a month after an Eli Lilly employee at a Branchburg, N.J. manufacturing facility filed a complaint alleging improper conduct at the facility manufacturing the company’s COVID-19 antibody treatments, the U.S. Department of Justice is now stepping in.
In a filing with the U.S. Securities and Exchange Commission, Eli Lilly acknowledged receiving a subpoena from the DOJ seeking documents related to the manufacturing. Lilly said it is cooperating fully with the investigation and is in the process of conducting its own investigation into the allegations made against the company.
“Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority,” the company said in its filing.
The anonymous complaint filed with the company in April alleged that individuals at the management level at the facility were rewriting findings from research and technical teams to show more favorable results regarding quality control, Reuters reported.
The anonymous source, who spoke with Reuters on condition of anonymity after the complaint first became public, said the findings that were being rewritten involved the production of the company’s coronavirus antibody treatment, bamlanivimab, which has been authorized under emergency use in combination with another drug as a treatment for mild to moderate COVID-19 patients who are at risk of developing severe illness.
The complaint did not specify what was altered in the documents. However, the report singled out the executive who is allegedly involved, Lydia Wible, according to the report. The anonymous source said Wible “rewrites factual data provided by subject matter experts to formulate responses she feels are more beneficial,” Reuters reported.
In addition to Wible, the source said others were involved but declined to name names for fear of retaliation. It is estimated that about 13 people were involved in the alleged rewriting of reports.
A human resources officer at the Branchburg site also claimed she was terminated after raising concerns about quality control, record keeping, and staffing at the facility.
It is still unclear whether any of the documents have been submitted to the FDA, although the agency routinely reviews such records. However, the Branchburg site has previously been scrutinized by the U.S. Food and Drug Administration. Last year, inspectors from the regulatory agency cited the facility on two counts of inadequate control of its computer systems. The FDA said the findings included deleted manufacturing process data and questioned its quality control over audit paper trails.
Lilly’s manufacturing woes aren’t tied to just the Branchburg site. In March, FDA inspectors also flagged a manufacturing facility in Indianapolis for issues. That site is involved with the bottling of the company’s COVID-19 antibody and other drugs. According to Reuters, the FDA found substandard sanitation and quality control procedures.
