AUTH/3445/12/20 - Complainant v Novo Nordisk

Promotion of Ozempic

  • Received
    19 December 2020
  • Case number
  • Applicable Code year
  • Completed
    14 June 2021
  • No breach Clause(s)
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

A contactable complainant who described him/herself as a concerned health professional complained about a promotional email (ref UK20OZM00311) for Ozempic (semaglutide solution for injection) sent by Novo Nordisk Limited. Ozempic was indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise, either as monotherapy or in combination with other medicines.

The complainant noted that the email detailed the results from the SUSTAIN 7 trial but did not state that one of the inclusion criteria was that patients had to be over the age of 18 years. Only further down and in much smaller writing did the email clarify that the treatment was only for adults, not all type 2 diabetes patients. The complainant submitted that type 2 diabetes was increasingly common in teenagers and so this was a serious omission. The complainant alleged that Ozempic had been promoted off licence.

The detailed response from Novo Nordisk is given below.

The Panel noted that the email at issue included ‘Could Ozempic help in the management of your patients with type 2 diabetes?’ followed by the claim ‘Ozempic has proven efficacy in decreasing HbA1c and could help your patients to reach their targets’. This was followed by information about the SUSTAIN 7 clinical trials and an invitation for the reader to ‘Learn more about the efficacy and tolerability of Ozempic for your patients with type 2 diabetes’. Beneath this, in smaller less prominent font, was the Ozempic indication followed by another link to prescribing information and adverse event reporting.

The Panel noted that the full indication for Ozempic, stating that it was licensed for the treatment of adults with type 2 diabetes, was towards the end of the email, after the information about SUSTAIN 7. The Panel noted Novo Nordisk’s submission that there was no suggestion within the email that Ozempic should be used in patients under 18 years of age. In the Panel’s view, it would be unusual for a patient with type 2 diabetes to be under 18 years old. Health professionals would take particular care when prescribing for such patients.

The Panel considered the immediate and overall impression to a busy health professional. There was no specific mention in the email or impression given that the email related to patients with type 2 diabetes who were under 18 years old. In the Panel’s view, although it might have been helpful for the indication to have been nearer the beginning of the email, the email overall was not misleading in relation to the licensed indication as alleged and the Panel ruled no breaches of the Code including Clause 2.