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 The Indianapolis-based company on Sept. 24 issued a voluntary U.S.
recall of one lot of the kits whose key ingredient is Glucagon, a
drug used to treat dangerously low blood sugar in diabetes patients.
The company issued a voluntary recall in Canada the following day.
Lilly’s recall notices said that the company had received a report
of a patient who experienced seizures even after being injected with
the drug, a sign that the treatment was not potent enough to work.
The company said the product failure might be related to its
manufacturing process, without elaborating.
In response to Reuters’ inquiries, Lilly told the news organization
that the affected kits were produced at a company facility in
Indianapolis, and that the kit that prompted the recall had been
distributed in Canada. As Reuters reported in May, the Indianapolis
plant had been cited by U.S. health regulators
https://www.reuters.com/business/
healthcare-pharmaceuticals/exclusive-lilly-hit-by-staff-accusations-fda-scrutiny-covid-drug-factories-2021-05-05
for substandard sanitation and quality control procedures.
Separately, Lilly is facing a federal criminal investigation
https://www.reuters.com/business/legal/
exclusive-us-opens-criminal-probe-into-alleged-lapses-eli-lilly-plant-2021-05-27
into alleged manufacturing irregularities involving another of its
U.S. factories in New Jersey, details of which were first reported
by Reuters https://www.reuters.com/article/us-health-elililly-special-report/special-report-insider-alleges-eli-lilly-blocked-her-efforts-to-sound-alarms-about-u-s-drug-factory-idUSKBN2B31K5
earlier this year. The recall of Glucagon kits made in Indianapolis
is the first indication of potential patient harm due to recent
manufacturing issues at the company’s plants.
“Lilly is deeply committed to manufacturing high-quality medicines
for patients who need them—nothing is more important to us,” the
company said in a statement. “We take our obligations seriously and
have rigorous quality systems in place to ensure compliance with
stringent regulatory requirements.”
In all, roughly 66,000 Glucagon Emergency Kits were affected by the
recalls, Lilly spokeswoman Kathryn Beiser told Reuters. She said
about 19,000 of those were distributed to U.S. customers and nearly
all the rest in Canada. She said the kits were produced at the
Indianapolis plant around May 2020. Beiser declined to say whether
Lilly has received other reports of adverse events related to the
Glucagon kits.
EMERGENCY KITS
The recalled Glucagon Emergency Kit was designed for diabetes
patients whose blood sugar is plummeting, and who need to raise it
quickly to avoid complications that can include seizures or death.
The kit consists of a vial, which is supposed to contain
freeze-dried Glucagon powder, and a separate syringe filled with
liquid.
Normally, a caregiver inserts the liquid-filled syringe needle into
the Glucagon vial in order to dilute the powder before administering
it. Lilly's recall announcement said the vial used by the stricken
patient contained liquid, instead of powder.
The company’s Indianapolis plant performs what is known in the
industry as “fill and finish” - receiving raw drugs made at other
facilities, putting them into vials and syringes, and shipping them
to customers.
U.S. Food and Drug Administration inspection records from March 2021
viewed by Reuters cited numerous quality-control violations at that
plant, such as staff failing to properly monitor environmental
conditions where the finished drugs are made and failing to
establish appropriate procedures to prevent contamination.
The FDA inspectors said they observed lapses in the manufacturing of
the Glucagon kits as well as in Lilly’s COVID-19 antibody therapy
bamlanivimab and several other drugs, according to the inspection
records, dated March 16. They concluded that Lilly must take steps
to remedy the lapses but did not recommend regulatory action on the
part of the FDA.
Lilly spokeswoman Beiser said U.S. distribution of Glucagon
Emergency Kits from the lot that was later recalled had ceased by
March 25, a little more than a week after the FDA inspection report.
Beiser said the distribution of the lot followed its regular process
via wholesaler channels and was not related to the FDA report,
adding that “any suggestion" it ended for other reasons is false.
[to top of second column] |
 Meanwhile, emergency kits from that same batch
continued to be distributed in Canada, Beiser
said. Distribution of 44,000 kits in Canada
began in February 2021 and continued through the
middle of September, she said. The patient
complaint that triggered the late September
recall involved a kit that had been shipped to
Canada, Beiser told Reuters.
Beiser declined to comment specifically on why
distribution of Glucagon Emergency Kits from the
batch continued for another six months in Canada
after distribution had ceased in the United
States. She did not answer questions about
whether the affected patient recovered.
Health Canada, a regulatory agency similar to
the U.S. FDA, declined to comment about Lilly’s
voluntary recall of the Glucagon Emergency Kits,
or why kits from the batch continued to be
distributed in Canada for months after they had
ceased to be distributed in the United States.
The FDA declined to comment on distribution of
the kits, whether it had received other reports
of adverse events, had re-inspected Lilly's
Indianapolis facility or if it planned
additional actions related to the recall.
“It is important to note that this recall was a
voluntary action taken by the company,” FDA
spokesman Jeremy Kahn said, without elaborating.
“We have been closely evaluating this event and
will continue to monitor the marketplace and
manufacturing efforts to help ensure the
availability of safe products for U.S.
consumers.”
FEDERAL PROBE
The recall comes as Lilly faces a criminal
investigation by the U.S. Department of Justice
into alleged manufacturing irregularities and
records-tampering at a separate factory in
Branchburg, New Jersey, that produces
bamlanivimab and other drugs.
The Justice Department has not accused Lilly of
any wrongdoing, and the company said earlier
this year that it is cooperating in the probe.
Lilly did not respond to a question from Reuters
about the status of that investigation. The
Justice Department did not respond to a request
for comment.
Bamlanivimab, the COVID-19 antibody,
manufactured at the Branchburg facility has been
sent to the Indianapolis fill-and-finish plant
to be put into vials and shipped.
A group of FDA inspectors arrived at the
Indianapolis plant in mid-February and stayed
for more than two weeks, according to a redacted
version of their report, which Reuters obtained
via a Freedom of Information Act request.
In their report, the inspectors listed Glucagon
as among the drugs where Lilly “failed to
establish an adequate system for monitoring
environmental conditions,” and noted that Lilly
failed to establish and follow appropriate
written procedures “to prevent microbiological
contamination of drug products purporting to be
sterile.”
In addition, the inspectors said Lilly did not
properly conduct quality-control sampling of
glass components like vials and pharmaceutical
ingredients for drugs including Glucagon,
bamlanivimab and the cancer drug Cyramza.
In Lilly’s April 6 response to the FDA obtained
by Reuters through an open records request, the
company said it takes the inspectors’ findings
“very seriously” and is implementing actions to
resolve concerns “on aggressive timelines.”
Lilly said it has established a comprehensive
environmental monitoring program designed to
assess microbiological control of manufacturing
spaces, the redacted response said. The company
did not respond to questions about the status of
its efforts to rectify violations noted by the
FDA at the Indianapolis plant.
(Reporting by Dan Levine in San Francisco and
Marisa Taylor in Washington, DC; Additional
reporting by Allison Martell in Toronto; Editing
by Michele Gershberg and Marla Dickerson)
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