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Eli Lilly, a leading pharmaceutical company, is under renewed scrutiny as U.S. inspectors unveil fresh manufacturing problems at its Branchburg, New Jersey plant. This revelation comes amidst an ongoing federal investigation into the facility’s practices.
FDA Inspection Findings:
A July U.S. Food and Drug Administration (FDA) inspection identified eight deficiencies at the Branchburg plant.
Issues ranged from shortcomings in tracking the manufacturing process and quality controls to calibration problems with equipment and inadequate facility maintenance.
Lilly’s Response and FDA’s Silence:
Eli Lilly responded, stating that it had requested the FDA’s permission for additional flexibility in manufacturing migraine treatment Emgality on a different production line.
The company assured that the inspection’s findings did not impact the quality, safety, or supply of any current or planned Lilly products in the market. The FDA, however, declined to comment on the situation.
Impact on Products and Operations:
While Lilly did not disclose the affected products, it confirmed that the migraine treatment Emgality was a focus of the requested manufacturing flexibility.
Other drugs produced at the Branchburg plant include the widely used diabetes medicine Trulicity and cancer treatments Erbitux and Cyramza.
Recurring Manufacturing Concerns:
Eli Lilly, the world’s most valuable healthcare company by market capitalization, has faced multiple citations for manufacturing issues at its U.S. plants in recent years.
The Branchburg facility, in particular, has been under investigation by the U.S. Department of Justice following allegations of poor practices and data falsification.
Regulatory experts reviewing the latest inspection report expressed serious concerns. Issues such as inadequate protection of electronic records, insufficient staff training, and neglect of equipment were highlighted.
Former FDA official Steven Lynn remarked that addressing one set of problems seemed to lead to new concerns at the Branchburg plant.
Legal Settlement and Continued Investigations
Experts suggested that the FDA might categorize the lapses as the most serious, “Official Action Indicated,” when responding to the inspection findings.
The timing and severity of the FDA’s response remain uncertain. However, the ultimate rating may be less severe if Eli Lilly has taken robust corrective actions to ensure drug quality at the facility.
Late last year, Eli Lilly settled a lawsuit with a former employee who claimed termination after reporting manufacturing issues and data falsification. The company denied the allegations.
The ongoing Department of Justice probe into the Branchburg facility’s practices remains unresolved, with Lilly and the Justice Department declining to comment on its status.
