Novo Nordisk issued FDA warning letter over adverse event reporting
Novo Nordisk Inc. (NYSE: NVO) received a warning letter from the U.S. Food and Drug Administration for violations of postmarketing adverse drug experience reporting requirements, according to an FDA document dated January 2025.
The FDA conducted an inspection of Novo Nordisk's U.S. operations between January 13 and February 7, 2025, focusing on the company's compliance with adverse event reporting regulations for products containing semaglutide, liraglutide, nedosiran sodium, and estradiol.
The agency identified failures in developing written procedures for surveillance, receipt, evaluation, and reporting of postmarketing adverse drug experiences. The FDA found that Novo Nordisk's procedures allowed adverse events to be rejected or cancelled if reporters considered them unrelated to the product, inconsistent with federal regulations requiring all adverse events to be reported regardless of perceived causality.
The inspection revealed that Novo Nordisk failed to report serious and unexpected adverse events to the FDA within the required 15-day timeframe. Examples included cases where patients experienced strokes, deaths, and suicidal ideation while taking company products, but these were not reported due to procedural deficiencies.
The FDA also found that Novo Nordisk inappropriately invalidated reports due to claimed lack of patient identifiers, even when such identifiers were available in source documents. Additionally, the company's procedures required unnecessary consent from reporters before following up on adverse events, which delayed investigations.
Novo Nordisk submitted multiple written responses to the FDA between March 2025 and January 2026, describing corrective actions including procedure revisions, retrospective case reviews, and plans to transition safety case intake from contracted call centers to internal healthcare professionals.
The FDA stated that the company's responses were inadequate and did not provide sufficient details to demonstrate that proposed actions would prevent future violations. The agency expressed concerns about systemic failures in Novo Nordisk's adverse event reporting system and its oversight of contractors handling safety responsibilities.
The warning letter requires Novo Nordisk to respond within 15 business days with actions taken to prevent similar violations. The FDA noted that failure to address these issues adequately may lead to regulatory action.