By Marisa Taylor and Dan Levine
March 11 (Reuters) - On a chilly spring morning in 2019, Amrit Mula arrived in her office at pharmaceutical giant Eli Lilly and Co´s factory in Branchburg, New Jersey,
시알리스비아그라차이 to find a desk drawer open that she had kept locked. Her files were missing.
Mula was a top human resources officer at what was one of America´s largest biotech plants. Over the years, she had been investigating employee complaints about manufacturing problems related to multiple drugs, including the company´s blockbuster diabetes medication, Trulicity, according to internal company documents and email correspondence reviewed by Reuters.
Among the most serious allegations: Records had been falsified or destroyed in the wake of manufacturing mistakes. In one case, according to 2018 emails among executives, company-mandated quality assurance documents were missing for Trulicity, which security filings show garnered more than $4 billion in sales in 2019.
Shortly after Mula discovered her files missing that day, her boss told her that Lilly was eliminating her position at the Branchburg plant, where she had worked nearly 15 years, according to a confidential "demand" letter from Mula´s lawyers to Lilly´s attorneys dated Dec. 30, 2019.
The letter, which seeks unspecified damages, portrays Mula as a good-faith whistleblower who repeatedly pressed her superiors to address serious problems at the factory, including staffing shortages, poor training, and record destruction and falsifications. Her inquiries, according to the letter and internal correspondence, were downplayed, ignored and sometimes blocked.
When she persisted, Lilly responded by "marginalizing, harassing and eventually terminating" her, according to the demand letter. Mula has not sued her former employer.
Reuters could not independently verify every claim in the letter. However, 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 U.S. Food and Drug Administration inspectors later identified some of the same concerns there.
"I was just doing my job," Mula told Reuters, declining to comment further.The demand letter and supporting documentation offer a rare look inside a Big Pharma company - one of the world´s largest - as it struggles with allegations of serious manufacturing violations, which can occur behind the scenes without being promptly investigated and addressed by a company or the FDA.
The pharmaceutical industry has become increasingly reliant on high-priced biologic drugs, like those made at Branchburg, for its profits. Made from living organisms, biologics are difficult and expensive to produce, and batches are particularly prone to microbial contamination.
In a statement, Lilly spokeswoman Kathryn Beiser said the company has "rigorous" quality assurance systems in place and welcomes feedback from employees.
Lilly is working closely with the FDA to address concerns about the factory, Beiser said, and the drugmaker voluntarily conducted a retrospective five-year review that found no impact on Branchburg's product quality.
Lilly has "long-standing policies and procedures that enable - and encourage - individuals to come forward with information about any potential issues or concerns without fear of retribution," Beiser said. "We are continuously strengthening and reinforcing a culture where our employees can be proud of our work, so in turn, doctors and patients can trust Lilly´s products have been ethically, properly, and safely manufactured."
Beiser did not specifically address the issues raised by Mula.On Tuesday, several days after receiving detailed questions from Reuters, Lilly announced the retirements of two senior vice presidents: Myles O´Neill, who heads Lilly´s manufacturing operations, and Melissa Barnes, who is chief ethics and compliance officer.
Beiser said the retirements were "long planned changes that reflect Lilly´s robust succession planning process" and that the company is grateful for the executives' "tremendous" contributions. O´Neill and Barnes did not reply to emails seeking comment.
The internal Lilly documents portray a plant where a worker complained in capital letters about being "TIRED AND OVERBURDENED"; where substandard chemicals and ingredients were simply discarded and not reported as required; where safety hazards included the risk of electrocution from live wires; and where quality assurance records disappeared or were doctored. In one case, according to a 2018 email among managers, workers sifted through the garbage to find missing manufacturing records.
The FDA requires pharmaceutical companies to closely track such documents, including recording any deviations from mandated procedures. The record-keeping requirements are key to ensuring the
quality of drugs, as
defects may not be obvious to consumers or physicians,
시알리스비아그라차이 pharmaceutical and regulatory experts told Reuters. The FDA also requires companies to hire enough staff members and properly train them to ensure compliance with regulations.
As associate director of HR and employee relations since 2011, Mula was tasked with investigating workplace issues including manufacturing complaints. In doing so, she repeatedly encountered a lack of cooperation or pushback from her bosses, according to contemporaneous emails, Mula´s handwritten meeting notes and excerpts from an internal retaliation complaint she filed with the company in December 2018.
"I submit that (executives´) motivation was to discredit and deter me from completing the investigations that were yielding unfavorable results," she wrote in the internal complaint, which was excerpted in the February 19, 2019, email to her direct supervisor.
At times, her bosses acted on her recommendations or said they would pass her concerns up the management chain, according to internal correspondence.
But the problems largely remained. Months after Mula left, FDA inspectors cited some of the same lapses she had flagged during her tenure and described in her demand letter. For instance, the inspectors found that on several occasions when serious manufacturing quality problems occurred - including in the case of Trulicity ingredients - "the firm failed to conduct a detailed investigation," according to an August 21, 2020, FDA report.
Overall, the FDA classified its inspectors´ findings at the plant as "Official Action Indicated" or OAI, the most serious category of violations, according to FDA correspondence and reports reviewed by Reuters. If the problems aren´t corrected, an OAI finding can lead to the FDA's prohibiting the sale of drugs made at the facility, drug quality experts told Reuters. The finding is the most serious sanction Lilly has received in about 12 years and is issued in only 7% of U.S. plant inspections, according to FDA records. The agency has not taken further public action.
Even so, the FDA announced last year that an antibody drug made at the Lilly plant called bamlanivimab could be used to treat COVID-19 on an emergency basis. After its inspections at Branchburg, the FDA required an independent lab to test batches of the treatment made there.
The FDA declined to comment, saying it does not usually discuss its dialogue with individual companies. The inspection reports reviewed by Reuters were heavily redacted by the agency to protect the company´s trade secrets and financial information.