AUTH/3445/12/20: Novo Nordisk Ozempic email alleged off-label promotion to under-18s (No breach)

📅 2020 | 🖉 Dr Anzal Qurbain
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Key facts

Case numberAUTH/3445/12/20
CompanyNovo Nordisk Limited
ProductOzempic (semaglutide solution for injection)
MaterialPromotional email (ref UK20OZM00311) sent via Pulse
Main allegationImplied promotion to under-18s / off-licence because adult-only indication was later and less prominent
Key trial mentionedSUSTAIN 7 (plus post-hoc analysis for baseline HbA1c >75 mmol/mol)
Clauses considered2, 7.2, 9.1
OutcomeNo breach
Complaint received19 December 2020
Case completed14 June 2021
Applicable Code year2019
AppealNo appeal

Download the full case report (PDF)


Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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What happened

  • A health professional complained about a Novo Nordisk promotional email for Ozempic (semaglutide) (ref UK20OZM00311) sent via Pulse.
  • The email referenced SUSTAIN 7 data and included claims such as “Could Ozempic help in the management of your patients with type 2 diabetes?” and “Ozempic has proven efficacy in decreasing HbA1c and could help your patients to reach their targets”.
  • The complainant alleged the email did not clearly state upfront that Ozempic was for adults (18+), and that the adult-only indication appeared later in smaller text.
  • The complainant argued this was a serious omission given increasing type 2 diabetes in teenagers, and alleged off-licence promotion.
  • Novo Nordisk denied any breach, stating the adult indication was included in the email, accessible via a prominent prescribing information link, and repeated on linked promotional webpages.
  • The Authority asked Novo Nordisk to consider Clauses 2, 7.2 and 9.1.
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Outcome

  • No breach of Clause 7.2.
  • No breach of Clause 9.1.
  • No breach of Clause 2.
  • Panel noted it might have been helpful for the indication to appear nearer the beginning, but the email was not misleading overall.
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