Drugs

Lilly Employees Say Exec Rewrote FDA Reports

An internal Eli Lilly complaint says that a factory executive changed technical documents required by government regulators to downplay serious quality control problems at the facility that makes the company’s Covid-19 therapy. Reuters reports in an exclusive story that the complaint involves Lydia Wible, an executive at the Lilly Branchburg, N.J., facility that manufactures its bamlanivimab coronavirus antibody treatment. Wible did not respond to a Reuters request for comment.

The report also says that in a separate action, FDA inspectors in March identified numerous manufacturing lapses at a Lilly facility in Indianapolis that bottles the Covid-19 therapy and other drugs. The problems reportedly included substandard sanitation and quality control procedures.

“The troubles at the two factories, along with a succession of internal complaints in recent years, deepen the regulatory, production, and leadership issues facing Lilly …,” Reuters says.

Contacted by Reuters, the company confirmed receiving an employee complaint about the Branchburg plant and said that it would not comment further due to an investigation underway by an unidentified independent third party.

“Depending on the outcome of that investigation, we will take appropriate action,” Lilly spokesperson Kathryn Beiser told the news service. “Lilly has long-standing policies and procedures designed to enable, and encourage, individuals to come forward with information about any potential issues or concerns without fear of retribution.”

The company also said it had responded to FDA about the Indianapolis inspection and would not share that response with Reuters.

The employee complaint reportedly did not specify what alterations the employees believed were made to the documents, but said Wible “rewrites factual data provided by subject matter experts to formulate responses she feels are more beneficial.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome