Quality control problems have already plagued one COVID-19 vaccine manufacturer in Baltimore, Maryland. Now, it appears they’re threatening to trip up a major pandemic therapeutic supplier as well.
Eli Lilly employees have accused an executive at the drugmaker’s Branchburg, New Jersey, manufacturing site of altering FDA-required documents in an effort to downplay serious quality control problems, Reuters reported on Wednesday, citing internal complaint documents and a source familiar with the matter.
The complaint, dated April 8, said the executive tasked with quality controls rewrote findings from Lilly’s technical experts at the facility, which produces doses of the company’s COVID-19 antibody treatment bamlanivimab, in order to make them look more favorable, according to the report.
The findings from the technical experts included the production of bamlanivimab, which has been widely deployed in the U.S. to treat adult and certain pediatric COVID-19 patients with mild-to-moderate disease, the source told Reuters. While federal regulators recently revoked bamlanivimab’s emergency authorization when administered by itself, the drug can still be paired with etesevimab under an EUA issued in February.
The complaint was reportedly filed by more than 10 employees, including managers, who claimed they saw the findings before and after they were allegedly edited. However, the complaint did not name the employees, Reuters reports.
Lilly’s Branchburg manufacturing site has previously been subject to FDA scrutiny over inadequate "control of computer systems.” Meanwhile, a former human resources employee at the facility previously claimed she was ousted from her job after raising concerns over its quality controls, record keeping and staff shortages, Reuters reported in March.
A Lilly spokesperson confirmed the employees’ complaint to Fierce Pharma and said the company takes all reports of “improper or inappropriate conduct seriously.” The drugmaker has already launched an external investigation into the complaints, which is still ongoing.
“Depending on the outcome of that investigation, we will take appropriate action,” Lilly said in an email.
Separate from that complaint, the news service also reported on Wednesday that the FDA found numerous quality problems at a second Lilly facility in Indianapolis that bottles Lilly’s bamlanivimab and other drug products during inspections conducted in March.
The issues included substandard sanitation and quality control procedures, according to a preliminary FDA inspection report Reuters obtained through an open records request. Lilly also confirmed the FDA’s inspection in an email to Fierce Pharma, calling it a “general surveillance inspection” of the facility.
The drugmaker said it has responded to the issues raised during the FDA’s observations and added that none of them have “affected any finished product or product in the marketplace that was manufactured in this facility.”
Lilly, which updated its bamlanivimab supply deal with the U.S. in April to focus on its combo treatment, said it still expects to meet its production commitments.
The U.S. government agreed to buy a minimum of 100,000 doses of bamlanivimab and etesevimab together for $210 million at the end of February, with the option of securing an additional 1.1 million doses through November.
The COVID-19 therapeutics have produced a hefty sales boost for Lilly. The drugmaker made $810 million from the two drugs combined in the first quarter this year and estimates $1 billion to $1.5 billion in revenue from the treatments through 2021.