The U.S. Food and Drug Administration (FDA), not the clinical sponsor, paused a recent study based on serious quality control issues at a production facility of Eli Lilly and Co. Apparently, this plant represented one of the facilities the company was preparing to utilize to ramp up production of the monoclonal antibody-based product touted by POTUS as “a cure” for COVID-19 based on government documents and three sources familiar with the issue reports Reuters. Both Lilly and Regeneron have invested heavily alongside support from the U.S. government in advanced monoclonal antibodies targeting SARS-CoV-2, the virus behind the pandemic.
According to a Reuters findings by the FDA, not previously disclosed despite the fact that Lilly has submitted an emergency use authorization (EUA), may complicate the pharmaceutical company’s effort to secure any authorization. The news agency cites two internal sources and outside legal experts. After all, U.S. law does preclude approvals if regulatory compliance measures are not up to standard. Reuters is talking to individuals that are concerned about retaliation and hence requested anonymity.
Apparently, the issue centers on Lilly’s Branchburg, New Jersey facility last November: data associated with the company’s manufacturing process was for some reason “…deleted and not appropriately audited” according to government documents.
Official Action Indicated (OAI) Notice
Because of this incident, the FDA classified as the most serious calling for action, called “Official Action Indicated” (OAI) notice reports Dan Levine and Marisa Taylor of Reuters. Patricia Zettler, a law professor at Ohio State University and former FDA associate chief counsel commented to the Reuters team that this “means that the violations are serious enough and have significant enough impact on the public health that something needs to be fixed.”
Real Reason for Pause
TrialSite reported that the pause was due to Lilly’s concern for safety based on some observations of data during the clinical trial. Now Reuters reports that actually Lilly commented this week that it was the National Institutes of Allergy and Infectious Diseases (NIAID) that paused the government-backed clinical trial involving hospitalized patients “out of an abundance of caution” given the safety concern. Of course, the company supported the decision but didn’t disclose any relevant or material information to the public—one that seeks more transparency from both the government and clinical trial sponsors.
Why weren’t these matters disclosed in a timely way? Why didn’t the U.S. FDA pause the study? Apparently, Lilly hasn’t disclosed the background information—does it think that this helps the overall cause? In the rush to produce advanced therapies health and human safety comes first. Companies were receiving government funding. Does this introduce certain obligations on the part of the sponsor?
Call to Action: Follow the link to the story authored by Mr. Levine and Ms. Taylor here. Send TrialSite your comments.