FDA Issues Warning Letter to Novo Nordisk Inc. Regarding Postmarketing Safety Reporting
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to Novo Nordisk Inc. (NNI) following an inspection conducted between January and February 2025. The inspection identified serious violations of Postmarketing Adverse Drug Experience (PADE) reporting requirements.
💠Key Findings from the FDA Inspection:
🔹 Failure to Report Serious Events: NNI failed to report certain “serious and unexpected” adverse drug experiences (ADEs) to the FDA within the mandatory 15-calendar-day timeframe.
🔹 Procedural Gaps in Causality Assessment: Internal procedures incorrectly allowed ADEs to be rejected or cancelled if the reporter believed the event was unrelated to the product. FDA regulations require reporting regardless of whether the event is considered drug-related.
🔹 Invalidation of Valid Reports: The FDA found that NNI and its call-center contractors inappropriately invalidated reports (including a report of a patient death) due to a perceived lack of patient identifiers, despite identifiers being present in the source documents.
🔹 Lack of Investigation: The company failed to promptly investigate serious ADEs—including a case of suicide—because internal procedures mistakenly required explicit consent from the reporter before following up.
🔸 Impacted Product Ingredients Noted: The violations concerned safety reporting for products containing: Semaglutide, Liraglutide, Nedosiran sodium, Estradiol.
🔶 FDA’s Stance and Required Action: The FDA emphasized that failure to report and investigate ADEs limits the agency’s ability to monitor drug safety profiles and protect public health. Novo Nordisk has been given 15 business days to provide a written response detailing the corrective actions taken to resolve these deficiencies and prevent recurrence across their entire product portfolio.