REUTERS: 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, according to government documents and three sources familiar with the matter.
Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant's various manufacturing processes had been deleted and not appropriately audited, government inspection documents show."The deleted incidents and related audit trail were not reviewed by the quality unit," the FDA inspectors wrote.
One of the sources told Reuters that Lilly employees had complained about problems at the plant, including insufficient staffing and falsified records tracking whether workers had followed FDA manufacturing standards.Out of 563 total inspections concluded in fiscal year 2019 by the FDA across the country, only a small fraction resulted in the most serious OAI classification, FDA data shows, and no other Lilly facility has received such a notice in at least 10 years.
Now under increased pressure to act swiftly against the pandemic, the FDA has discretion to approve Lilly's COVID-19 therapy for emergency use even if the manufacturing issues have not been fully resolved. Leading scientists have pointed to antibody drugs as a promising way to treat people who are already sick, and also to temporarily prevent infection in people at high risk of COVID-19, until a successful vaccine is identified.
No such agreement has been reached with Lilly, but the government's interest in its therapy appears keen. Earlier this month, Warp Speed officials traveled to Branchburg to meet with Lilly executives, according to two sources briefed on the visit. Among the attendees were Lilly Chief Executive David Ricks and Chief Science Officer Dan Skovronsky, one source said.
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