DOJ issues subpoena to Eli Lilly over New Jersey plant

The Department of Justice (DOJ) issued a subpoena to pharmaceutical company Eli Lilly requesting documents associated with a manufacturing factory in New Jersey, the company confirmed on Thursday. 

The drugmaker said it received the subpoena this month seeking information about its site in Branchburg, N.J., which produces the diabetes drug Trulicity and the COVID-19 antibody drug bamlanivimab.

Eli Lilly said it was “cooperating fully with the investigation,” according to a U.S. Securities and Exchange Commission (SEC) document filed Thursday. 

“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 filing said.

Reuters first reported on the investigation on Thursday, citing three people familiar with the matter. The three sources told the outlet that the probe involving U.S. prosecutors and other officials in New Jersey and Washington, as well as the FBI, started in recent weeks. So far, the DOJ has not accused the company or its employees of wrongdoing. 

The Food and Drug Administration (FDA) had previously flagged the plant in question for alleged manufacturing and records violations. 

The agency first found that quality control data had been removed and not audited correctly in November 2019, according to Reuters. Then, in July, regulators discovered more issues, including that batches of drugs were scrapped due to manufacturing errors. 

A September report obtained by Reuters found Eli Lilly told the FDA that it took the problems “very seriously” and comprehended “the criticality of data integrity across the entirety of our operations.”

The investigation comes after Reuters reported in March that a former human resources officer asserted that she had to leave her job after examining employee complaints about manufacturing and records issues. 

The outlet also reported in April that several employees alleged in an unsigned internal complaint that a top quality official altered documents to minimize mistakes. 

In Thursday’s SEC filing, Eli Lilly said it previously instructed external counsel to run an independent probe of “certain allegations relating to its Branchburg facility” and said it’s investigating “thoroughly” through the counsel.  

The DOJ did not immediately respond to a request for comment. The FDA said it does not comment on possible or open investigations.