Drugs

Reuters Details Lilly Whistleblower Allegations

Attorneys for a former Eli Lilly senior human resources officer at the firm’s Branchburg, NJ, drug manufacturing facility say their client was a dedicated whistleblower who repeatedly pressed her superiors to address serious problems at the facility including staffing shortages, poor training, and record destruction and falsification. In a lengthy report, Reuters details the case of Amrit Mula who investigated employee complaints about manufacturing issues related to multiple drugs, including the blockbuster diabetes drug Trulicity.

The report says that among the most serious allegations she handled were reports that records had been falsified or destroyed in the wake of manufacturing mistakes.

Reuters reviewed a 12/30/19 letter sent to Lilly by Mula’s attorneys seeking unspecified damages after her position was eliminated. They said her inquiries were downplayed, ignored, and sometimes blocked. And when she persisted, the letter says, Lilly responded by “marginalizing, harassing, and eventually terminating her.”

Reuters says it could not independently verify every claim in the letter. “However,” it says, “based on internal correspondence and other company documents reviewed by reporters, Mula repeatedly received complaints and raised concerns about everything from quality control to record-keeping with a host of Lilly managers and executives. Three former factory workers who spoke to Reuters on condition of anonymity said such problems were endemic at Branchburg, and FDA inspectors later identified some of the same concerns there.”

In her only comment to the news service, Mula said, “I was just doing my job.”

Company spokesperson Kathryn Beiser said Lilly has “rigorous” quality assurance systems in place and welcomes employee feedback. She also said the firm is working closely with FDA to address concerns about the factory and voluntarily conducted a five-year retrospective review that found no impact on the facility’s product quality.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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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