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article imageFDA found serious violations at Eli Lilly plant making Covid drug

By Karen Graham     Oct 21, 2020 in Health
U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co. pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease.
Last week, according to Digital Journal, Eli Lilly said that the National Institute of Allergy and Infectious Diseases paused a phase three government-backed clinical trial of its ACTIV-3 monoclonal antibody treatment in hospitalized patients “out of an abundance of caution” over a potential safety concern.
Eli Lilly's drug trial is for its monoclonal antibody treatment that is used in combination with the anti-viral, remdesivir. This drug is similar to the Regeneron antibody cocktail, along with Remdesivir, that was given to President Donald Trump when he was diagnosed with COVID-19.
Trump is pushing for the Regeneron and the Eli Lilly treatment therapies to become available immediately on an emergency basis, raising questions by some policy experts over the possibility the administration will imminently release an Emergency Use Authorization (EUA) for the drug.
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However, Reuters is reporting that The Food and Drug Administration (FDA) had uncovered a number of serious quality control problems at the Eli Lilly plant in Branchburg, New Jersey in November, last year. And it was the government inspectors who called for a pause in the ACTIV-3 trial last week.
The FDA's findings had not been made public at that time, and according to two sources and two outside legal experts, the FDA findings could complicate the drugmaker’s request for an EUA for their therapy. This is because U.S. law requires compliance with manufacturing standards for authorization of a drug.
The sources who spoke with Reuters requested that their names be withheld so they could speak freely without fear of retaliation.
The government documents covering the November 2019 inspection, seen by Reuters, found that data on various manufacturing processes had been deleted and were not properly audited, according to Seeking Alpha.
“The deleted incidents and related audit trail were not reviewed by the quality unit,” the FDA inspectors wrote. Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.
The FDA classified the problems as the most serious level of violation, resulting in an “Official Action Indicated” (OAI) notice. That “means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,” said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.
On Monday, when questioned by Reuters, Eli Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action. The company did say they had launched a “comprehensive remediation plan,” has increased staffing at the site, and was working “aggressively” to address all concerns raised during the inspection.
The drugmaker also said the deletions found by inspectors had nothing to do with the COVID-19 treatment. “These findings do not impact product quality or patient safety, as outlined in a detailed assessment submitted to FDA,” the company’s statement said. “Lilly continues to provide updates to the FDA on progress towards completion of our detailed plan.”
However, in an October 2 memo, U.S. drug-safety inspectors found continuing quality-control problems at the New Jersey plant. FDA compliance officers wrote that findings from an inspection of the facility in July and August “support a major failure of quality assurance.” They noted that Lilly planned to make its antibody therapy at the plant and said the inspection group “feels it is still imperative that FDA take action," according to Bloomberg.
More about Eli Lilly, monoclonal antibody treatment, Safety concerns, Fda, Quality control
 
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