Escalating US regulatory scrutiny: FDA ad citation, safety reporting violations and TN AG 340B warning
Key Questions
What FDA warning did Novo Nordisk receive?
The FDA issued a warning to Novo Nordisk for failing to report serious suspected side effects, including deaths and suicidal thoughts, for Ozempic and Wegovy. This involves postmarketing adverse event reporting violations and an oral ad citation.
What is the Tennessee AG's action against Novo Nordisk?
The Tennessee Attorney General issued a 340B warning to Novo Nordisk. This adds to escalating U.S. regulatory scrutiny amid pricing and Hims-related issues.
What compliance risks does Novo Nordisk face?
Risks include delayed GLP-1 adverse event reporting, safety violations linked to Clayton/NJ deaths and suicides. These occur amid broader pricing pressures and telehealth partnerships.
FDA warning delayed GLP-1 AE reporting + oral ad (NJ 2025 insp, action plan/7 updates, no prod impact); TN AG 340B; Clayton/NJ deaths/suicide.
Sources (2)
Updated Apr 8, 2026