AUTH/3655/6/22 - Anonymous Health Professional v Novartis

Alleged promotion of Mayzent

  • Received
    06 June 2022
  • Case number
  • Applicable Code year
  • Completed
    27 June 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case was in relation to the promotion of Mayzent (siponimod) on the ‘Dosing and administration’ page on a Novartis website. 

The Panel ruled a breach of the following Clauses of the 2021 Code for referring to Mayzent initiation in patients with a history of myocardial infarction and heart failure without making apparent the absolute contra-indication in patients with a history of myocardial infarction or heart failure in the previous 6 months, except on a separate webpage and within the prescribing information which, in the Panel’s view, was insufficient to negate this immediate misleading impression: 

Breach of Clause 6.1

Providing misleading information

Breach of Clause 6.2

Providing a misleading impression which was incapable of substantiation

Breach of Clause 5.1

Failure to maintain high standards

Breach of Clause 2

Bringing discredit upon, and reducing confidence in, the pharmaceutical industry

The Panel ruled no breach of the following Clauses of the 2021 Code as it did not consider that highlighting the contraindication in pregnancy for Mayzent meant that health professionals would assume there would be no other considerations or contraindications:

No Breach of Clause 6.1

Requirement that claims must not be misleading

No Breach of Clause 6.2

Requirement that claims must be capable of substantiation

No Breach of Clause 5.1

Requirement to maintain high standards

No Breach of Clause 2

Requirement that activities or material must not bring discredit upon, or reduce confidence in, the pharmaceutical industry

This summary is not intended to be read in isolation.
            For full details, please see the full case report below.