Earlier this month, Eli Lilly’s COVID-19 drug factory in New Jersey garnered unwanted headlines for quality control snafus and alleged document tampering. Now, the Department of Justice (DOJ) has stepped in to investigate.
Thursday, Lilly revealed the DOJ has issued a subpoena demanding documents relating to the site in Branchburg, New Jersey. The site produces doses of Lilly's COVID-19 antibody treatment, which has recently faced setbacks for its susceptibility to certain variants.
Meanwhile, Lilly says it's working with outside counsel on an independent investigation. Lilly is "cooperating fully" with the DOJ probe, the company said in a Securities and Exchange Commission filing.
“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 drugmaker said in the filing. A Lilly spokesperson told Fierce Pharma that the company couldn't comment further.
In early May, Reuters reported that employees at the site accused an executive of altering FDA-required documents in an effort to downplay serious quality control problems, citing an internal complaint and a source familiar with the matter.
The complaint, dated April 8, said the executive rewrote findings from Lilly’s technical experts to make them look more favorable, Reuters reported.
The findings included details about 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 the FDA revoked its emergency authorization for that drug as a solo treatment in April, it can still be paired with etesevimab for high-risk patients. 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.
However, the U.S. has stopped shipping the combo treatment to a handful of states, citing a rising frequency of variants, specifically those found in South Africa and Brazil. It's thought that those variants are able to skirt the drug's protection.
Lilly's New Jersey site has had somewhat of a challenging year. Last October, the site faced 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.
At the time, Lilly confirmed the report to Fierce Pharma and said it had already launched an external investigation into the complaints and, depending on the outcome, would “take appropriate action.”