Eli Lilly's much-maligned Branchburg plant earns a federal subpoena amid whistleblower claims tied to Covid-19 work
With Eli Lilly’s work on Covid-19 antibodies facing multiple setbacks at the FDA and state level, the plant responsible for producing the drugs has seen a flush of employee complaints alleging fudged documents and poor conditions. Now, the Department of Justice is getting involved and wants to see Lilly’s paperwork.
The DOJ hit Lilly with a subpoena requesting additional documentation on its work at a Branchburg, NJ plant, the Indianapolis drugmaker said in an SEC filing. The scope of the DOJ’s investigation is unclear, but in early May, Reuters reported that the company’s employees accused an executive of altering documents required by regulators to downplay quality control problems at the plant.
The complaint alleged that the executive rewrote findings from a Lilly technical expert to make the conclusion more favorable.
“Lilly is cooperating fully with the investigation,” the drugmaker said in a statment. “Lilly had previously engaged external counsel to conduct an independent investigation of certain allegations relating to Branchburg. Lilly, through its counsel, is investigating these allegations thoroughly.”
The FDA has been investigating the plant that produces antibody bamlanivimab after issuing a two-observation Form 483 in August that noted quality and laboratory controls that were not up to par.
The accusations are the latest setback for Lilly’s Branchburg plant. The company’s EUA was pulled by the FDA after citing a rise in variants, and in March, Reuters reported that a human resources employee claimed she was fired after blowing the whistle on quality issues at the site. A history of missing documents was among those issues, with employees sometimes sent to dig through the trash to recover them.
The Form 483 also revealed that inadequate data surrounding GMP violations were disclosed in the necessary documents, and the company didn’t open a “deviation” investigation on at least one occasion because it cited a mixup as “an isolated occurrence,” despite similar incidents with similar circumstances.