- Eli Lilly has hired an outside consultant and is redoubling efforts at remediation after the Food and Drug Administration faulted the company's data handling at a plant in Branchburg, New Jersey.
- The FDA's criticisms "have our full attention," Lilly said in a statement. The Indiana-based drugmaker added that it has hired more staff and directed more resources to the facility, one of several that makes antibody designed to treat or possibly prevent coronavirus infections.
- The FDA issued a type of notice known as an Official Action Indicated, or OAI, but Lilly hasn’t received a warning letter or faced other enforcement actions. "We are confident that the issues raised during the Branchburg inspections did not impact product quality or patient safety," Lilly said.
Issues at the Branchburg plant are taking on greater significance in the context of the COVID-19 pandemic. Lilly said it’s sharing information because of "global interest" in its efforts to develop a treatment. The company earlier this month sought an emergency approval for the antibody therapy, known as bamlanivimab.
The company didn’t detail the issues raised by the FDA, other than saying they were related to "data handling." A November 2019 inspection found that employees at the plant hadn’t properly deleted and audited data, Reuters recently reported. A four-week inspection that ended in August found continuing problems with quality assurance, Bloomberg reported this week.
Lilly officials didn’t reply to a request for comment from BioPharma Dive. The company originally acquired the site through its $6.5 billion acquisition of ImClone Systems in 2008.
"We are confident in the quality systems for our global manufacturing processes," Lilly said in a statement Tuesday. "Our commitment to the safety of our medicines has not — and will not — change during our efforts to provide treatments to fight this global pandemic."
Cantor Fitzgerald analyst Louise Chen noted that the November inspection occurred before the site began production of bamlanivimab. Chen also emphasized that the issues from the original inspection report were related to the appropriate controls of electronic data, not manufacturing of therapies.
Yet the incident, along with the recent pause of a National Institutes of Health-led study for a safety review, threatens to delay the emergency clearance of Lilly's drug. A similar, rival treatment from Regeneron, which hasn't had the same issues, is also under an FDA evaluation and could get to market first.