Lilly Plant Stops COVID Drug Trial Over Safety Concern
U.S. Food and Drug Administration inspectors reportedly uncovered serious quality control problems at its pharmaceuticals plant in Branchburg, N.J., during a visit last November. (iStock/jetcityimage)
Eli Lilly recently paused clinical trials of its COVID-19 drug in hospitalized patients “out of an abundance of caution” over a potential safety concern. U.S. Food and Drug Administration (FDA) inspectors reportedly uncovered serious quality control problems at its pharmaceuticals plant in Branchburg, N.J., during a visit last November.
The FDA’s findings could complicate Lilly’s bid for an Emergency Use Authorization (EUA) from the federal agency, according to Reuters, because U.S. law requires compliance with manufacturing standards for authorization of a drug. The pharmaceutical company’s antibody therapy is experimental and not yet been approved by regulators as safe and effective.
FDA inspectors found that data on the plant’s manufacturing processes had been deleted and not appropriately audited, according to government inspection documents. “The deleted incidents and related audit trail were not reviewed by the quality unit,” the inspectors wrote.
After its November inspection, 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, former associate chief counsel at the FDA who is now a law professor at Ohio State University.
Lilly confirmed the OAI notice to Reuters’ questions, but did not provide details on what prompted the FDA action. The company said it launched a comprehensive remediation plan, has increased staffing and was working “aggressively” to address all concerns raised during the inspection, according to Fox Business.
Out of 563 inspections in fiscal year 2019 by the FDA throughout the country, only a small fraction resulted in an OAI classification, according to FDA data. No other Lilly facility has received such a notice in at least 10 years.