(Reuters) – The US Department of Justice has launched a criminal investigation into Eli Lilly and Co. focusing on alleged manufacturing irregularities and registry forgeries at a factory in Branchburg, New Jersey, which produces the pharmaceutical giant's COVID-19 therapy and other drugs, said three people familiar with the matter.
The probe represents a significant escalation of the government's scrutiny of Lilly. The drug company, one of the world's largest, has been under investigation for more than a year by the U.S. Food and Drug Administration due to alleged manufacturing and registry violations at the Branchburg plant.
Reuters questioned Lilly about the criminal investigation on Wednesday. On Thursday morning, the company revealed in a securities archive that it had received a lawsuit from the Ministry of Justice this month to search for documents related to the Branchburg factory.
The company revealed nothing more about the nature or focus of the investigation and said that it cooperated fully in the matter.
Lilly said it had previously hired external advisers to conduct an independent investigation into certain allegations concerning the Branchburg plant. The company provided the same information to Reuters on Thursday in response to news agency questions.
"Lilly is deeply committed to manufacturing high quality medicines for patients who need them, and the safety and quality of our products is our top priority," said the company.
The Department of Justice's investigation follows a Reuters report in March that a HR manager Lilly claimed she had been forced to leave her job at the factory after conducting internal investigations into employees' complaints about manufacturing defects, forged or destroyed.
In April, employees accused a factory manager of altering FDA-required documents to downplay problems, according to an unsigned internal complaint reviewed by Reuters.
The company previously told Reuters that none of the issues flagged by FDA inspectors affected the quality of drugs released to physicians and patients. Lilly has also denied reprisals against employees.
The Department of Justice's investigation, which involves U.S. prosecutors and other officials in New Jersey and Washington, began in recent weeks, the three said. The FBI is involved in the probe, they said.
A spokesman for the New Jersey U.S. Attorney's Office declined to confirm or deny the existence of an investigation. The Department of Justice and FDA representatives in Washington had no immediate comment on the probe. The FBI declined to comment.
The investigation is in its early stages, the three people told Reuters, and the Justice Department has not blamed Lilly or any of its employees for wrongdoing. The department could ultimately prosecute criminal charges, seek civil sanctions or close the probe without taking action.
In November 201
Federal documents show that the FDA cited the issues in March 2020 as "Official Action Indicated", or OAI, which is its most serious category of infringement. If left untreated, an OAI could lead to a ban on the sale of drugs from a facility, regulators say. The FDA has not taken any further public action.
In October, the Trump administration ordered Lilly & # 39 ;s antibody therapy bamlanivimab, manufactured in Branchburg, for $ 375 million. Shortly afterwards, the FDA approved the drug's use in emergencies to help quell the pandemic. Bamlanivimab is now being combined with a second Lilly drug, called etesevimab, to treat COVID-19.
A condition of the state of emergency was that an external auditor inspect bamlanivimab batches to ensure that they met FDA standards. Lilly and the FDA have not responded to questions from Reuters about whether this requirement is met. Catalog