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 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, 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.
Three outside experts who reviewed the FDA inspection records for
Reuters said such manufacturing violations could erode the potency,
purity or safety of drugs. It’s crucial to log the processing
temperatures and times of drugs and what raw materials are used,
said Susan Bain, an assistant professor of regulatory and quality
sciences at the University of Southern California who once conducted
FDA factory inspections.
Based on her review of the FDA inspection records, she described the
quality assurance at the Branchburg plant as “so wildly out of
control it’s scary.”
“Ultimately, you don't know what the heck went on,” Bain added.
RISING DEMAND, SHRINKING STAFF
Lilly’s factory in Branchburg sits at an epicenter of U.S. drug
manufacturing, with many of the company’s competitors close by.
Mula went to work there in 2004, when the plant was owned by ImClone
Systems, then embroiled in an insider trading scandal involving
celebrity businesswoman Martha Stewart. Four years later, Eli Lilly
bought the company and the plant for $6.5 billion.
Ever since, the biologics produced in Branchburg have become
increasingly important to Lilly’s bottom line. Biologics are not as
easily copied by competitors as conventional pharmaceuticals are and
therefore can stay profitable longer.
Lilly developed Trulicity as Type-2 diabetes diagnoses exploded
worldwide. The widely advertised medicine, introduced in 2014, is
prescribed to help lower blood glucose levels and reduce, or avoid,
the need for regular insulin injections. Trulicity, which is
injected weekly, also may help with weight loss, according to a
Lilly promotional website.
After David Ricks became CEO in 2017, he sought to cut costs through
a global reduction of about 3,500 employees - roughly 8% of Lilly’s
staff. Many employees took early retirements, and a top quality
control official at the New Jersey plant departed.
Fewer and fewer employees at the Branchburg plant were available to
prepare critical ingredients used in manufacturing drugs, three
people who worked in the plant told Reuters. In addition, many
workers were assigned tasks above their experience and training
levels, they said.
Ricks referred Reuters questions to a Lilly spokesperson.
The process of manufacturing biologics is complex and delicate;
every step and ingredient is tightly controlled. The drugs start as
cells in large vats where they are fed ingredients to help them
multiply. Then the batches are purified in a series of containers
with substances to make them suitable for human absorption. Workers
in sterile areas are required to wear protective gear covering their
entire bodies. Even skin cell flaking was cited as a possible source
of contamination at Branchburg, according to a 2018 employee
complaint.
Critical tasks often required at least two people - one to perform a
step and another to verify it was done correctly. In some cases,
workers reported they didn’t have supervisors to check with on how
to properly handle contamination or disposal of unusable materials.
‘STOP THIS STUPIDITY’
By 2018, serious complaints from factory workers and allegations of
manufacturing violations were piling up on Mula’s desk, the internal
Lilly records reviewed by Reuters show.
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On Aug. 9, an anonymous employee called Lilly’s ethics and
compliance hot line to report that inadequate staffing and high
turnover was a problem at Branchburg, leading to a “heightened
stressful environment because employees are handling multiple jobs
at once,” according to a complaint recorded by the hot line call
center.
Around the same period, emails show, Mula was notified that
contamination or other errors in at least nine instances led
ingredients or other materials to be discarded. According to the
emails, Mula suspected in some cases that the items were improperly
disposed of or “dumped” inside the factory.
Two of the 2018 incidents involved Trulicity, Mula told her
supervisor, Richard Ruth, in emails the following February.
Altogether, Mula said at least $2 million in materials for various
drugs were lost to dumping, according to an email she sent to a
human resources superior, Efraim Ortiz, whom she thanked for
confirming that number.
Both Ortiz and Ruth declined to comment and referred questions to a
company spokesperson.
On Oct. 1, 2018, Mula received the complaint from an unidentified
factory employee in all-caps via interoffice mail, beseeching her
for help.
“WE ARE TIRED AND OVERBURDENED AND DON’T HAVE ENOUGH PEOPLE WORKING
ON THE FLOOR,” it said. “PLEASE SUPPORT US AND STOP THIS STUPIDITY.”
On October 11, Mula asked a quality assurance official in an email
if her unit had enough staff. The response: “No.”
In her statement, Lilly spokeswoman Beiser said the company ensures
that the staffing at all its sites is appropriate, and Branchburg
has seen only marginal variations in staffing levels over the past
six years. She did not disclose specific figures.
Then-plant manager Victor Cruz and other Branchburg executives
pledged at times to cooperate with Mula’s multiple inquiries, the
email correspondence shows. But some of the executives also
suggested to Mula that there wasn’t a quality problem at the plant,
or advised her to let officials in Lilly’s dedicated quality unit
resolve the matters.
“We would not proceed with executing any manufacturing operation if
we did not have the trained staff to perform that operation,” Liz
Gosen, then Branchburg’s vice president of manufacturing operations,
wrote to Mula in an October 2018 email. “This would be a violation
of our procedures.”
Mula also raised her concerns about staffing in an October meeting
with Lilly’s vice president of quality, Leanne Hickman, according to
emails between the two.
That same day, plant manager Cruz told Ruth he could no longer work
with Mula, emails show. Later, Mula heard that Cruz had announced at
a company party that she was going to be reassigned or removed,
according to the emails.
Two other managers also had filed complaints against Mula, accusing
her of badmouthing her superiors and spreading rumors about an
interoffice affair, the emails show.
Ruth later acknowledged in emails to Mula that the managers’
complaints had been unfounded and were dismissed.
It was “determined that there was no violation and no further action
regarding the allegations that were brought forward against you” was
needed, Ruth wrote in December 2018.
Cruz and Hickman did not respond to requests for comment. Gosen
declined to comment.
On Oct. 22, an associate director at the plant emailed Mula and two
others to report that records of a Trulicity manufacturing upgrade
were missing. Looking for the records entailed “climbing and sifting
through garbage,” the associate director said.
By then, turbocharged global demand had vaulted Trulicity over three
other Lilly drugs - including erectile dysfunction medicine Cialis -
to become the company’s best seller.
COMING TO A HEAD
The pressure on Mula mounted.
In February 2019 emails, a senior manufacturing executive, Darin
Moody, told factory managers that he had to attest to “material
compliance” with Lilly’s “Red Book” code of conduct and company
policies.
However, Mula emailed Ruth and Nellie Clark, who had replaced Cruz
as plant manager, on Feb. 5, saying that she “cannot with integrity
confirm that all (Branchburg) cases have been escalated as
appropriate” by the senior leadership team at the plant.
Mula brought up what she called “one reckless example” in January
2019 that had not been investigated: wet mopping around live
electrical wires, posing a risk of electrocution.
“The fact that the event didn’t result in a fatality is shocking,”
Mula wrote.
Mula told Ruth she was “excluded” from a meeting with the plant
leaders about the incident.
“I would ask that you permit me to do my job and examine the
situation despite anticipated rebuffs from Nellie (Clark) and Efraim
(Ortiz),” she wrote to Ruth.
Initially, plant managers recommended “verbal” coaching for the
employees involved. Ultimately, Mula successfully pushed for written
warnings, the emails show.
In email correspondence that February, Mula told Ruth that the
upper-level Branchburg managers were not providing detailed
information that she needed to conduct her inquiries.
Clark did not respond to requests for comment.
On Feb. 28, 2019, Ruth emailed Mula some positive news.
Ruth told Mula that she “sufficiently” met expectations and would be
receiving a bonus. In a later email, he complimented Mula on her
work on the electrical wires investigation: “Well done, Amrit.”
Around the same time, however, plant manager Clark told Mula she was
“displeased” with Mula’s findings of violations and recommendations
for discipline, according to Mula’s demand letter.
Shortly afterward, according to the letter, Mula met three Lilly
scientists who alleged that the company discarded a batch of
Trulicity worth $8 million to $10 million after data falsification
led to contamination during manufacturing. The letter says Clark
responded in a mid-March meeting: “We don’t want to mess with
Trulicity.” Clark then threatened to remove Mula from her position
at the Branchburg plant, the demand letter alleges.
Reuters could not independently confirm the mass discarding of
Trulicity or Clark’s comments about the drug or Mula.
On March 28, the day Mula found her files gone, Ruth flew into
Branchburg from Lilly’s Indianapolis headquarters, according to
email and instant messages he sent to Mula at the time. Once there,
he told her that her position was being eliminated.
According to a March 28 notification letter Mula received from the
company, the job was being eliminated due to a need to reallocate
resources “to compete in a new business environment.” Mula was
offered a roughly $96,000 severance and the opportunity to apply for
another position, according to the March 28 letter and her demand
letter.
ENTER THE FEDS
In November 2019, eight months after Mula’s dismissal, FDA
inspectors showed up at the plant for a routine inspection.
Among a host of problems cited by the inspectors: The company did
not keep proper records to verify that its quality management
systems were operating in compliance with FDA regulations - a
concern Mula had been raising for more than two years.
The FDA red-flagged the problems with its “Official Action
Indicated” designation.
On a subsequent inspection that began in July 2020, the FDA
discovered signs that Lilly was systematically downplaying
significant manufacturing problems, said Peter Calcott, a
pharmaceutical consultant and instructor at the extension program of
the University of California, Berkeley, among those who reviewed the
FDA records for Reuters.
“As a patient, I’m more worried about that,” Calcott said.
In July 2020, for instance, FDA inspectors found that when the
plant’s tests of a migraine treatment drug called Emgality showed
problems, the plant repeated those tests until it got the results
needed to finish the manufacturing process, according to the FDA
documents reviewed by Reuters.
During that same inspection, the FDA found that Lilly discarded a
batch of drug ingredients that had been used incorrectly in May
2020, without investigating the matter or keeping proper records. It
is not possible to tell from the redacted documents which drug was
at issue.
The company’s vice president of manufacturing, who is not named in
the FDA report, told the agency that the workers responsible “are no
longer employed with the firm” due to “the severity of the issue,”
the inspectors wrote.
FDA investigators said that the May incident and lack of follow-up
investigation was not an “isolated occurrence,” as they said Lilly
had claimed. They cited three similar instances in 2020 alone and
could not determine whether the company had addressed the problems,
according to their August inspection report.
In September, a month after the FDA inspection, Lilly drew up
internal talking points to brief employees on the agency’s findings
and remind them how to comply with regulations. Workers were
instructed, for instance, not to use informal record-keeping such as
“sticky notes.”
Lilly asserted in the briefing that it had made “tremendous
progress.” If problems arise again, the company advised employees,
“speak up.”
(Marisa Taylor reported from Washington, D.C.; Dan Levine from San
Francisco. Editing by Michele Gershberg and Julie Marquis)
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