When Eli Lilly last month revealed that the U.S. Department of Justice (DOJ) issued a subpoena into its manufacturing facility in Branchburg, New Jersey, the drugmaker's own independent investigation had already wrapped up and concluded the company didn't make false statements to the FDA, Reuters reports.
That's the takeaway in an internal memo sent to employees May 20 that said the company's independent, outside legal counsel concluded that "allegations that Lilly made false statements to the FDA were not substantiated," Reuters reported Thursday. Lilly declined to comment on the situation.
Still, the memo's conclusion differs slightly from the original allegations raised by plant workers. In an April complaint, employees at the plant expressed concern that an executive altered FDA-required documents in an effort to downplay serious quality control problems, the news service previously reported. The employees didn't specifically raise allegations that the company provided the FDA with misleading statements.
The employee complaint claimed an executive at the site rewrote findings from Lilly’s technical experts to make them look more favorable, Reuters previously 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.
At the time, a Lilly spokesperson maintained that the company was working with outside legal counsel to address the concerns and told Fierce Pharma that, depending on the outcome, it “will take appropriate action.”
Lilly later disclosed a DOJ probe into the plant on May 27.
In the internal memo, the company denied allegations that it made any false statements to the FDA. The Indianapolis-based company, however, didn’t cover all of the employee complaints in the note, Reuters reports. Lilly based its internal probe off more than 100 interviews, according to the news service.
While Lilly may have cleared itself in an internal probe, it remains to be seen how the DOJ will proceed. As Reuters notes, if federal prosecutors determine the company's probe was thorough, they may not press the issue much further. But if they find weaknesses in the internal investigation, they could take a tougher approach.
This isn’t the first time Lilly’s New Jersey site has come under fire. Last October, the facility faced FDA scrutiny over inadequate "control of computer systems” and a potential FDA warning letter. The site already received an “official action indicated” notice in November 2019.
Meanwhile, a former human resources employee at the site previously claimed she was ousted from her job after raising concerns over its quality controls, record keeping and staff shortages, Reuters reported in March.