AUTH/3727/1/23 - Complainant v Janssen

Symposium video on Janssen Medical Cloud website

  • Received
    12 January 2023
  • Case number
  • Applicable Code year
  • Completed
    28 February 2024
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case concerned a video of a symposium on pulmonary arterial hypertension published on a Janssen website which the complainant alleged was misleading by presenting:
• relative risk reduction information without the absolute risk reduction,
• a Kaplan–Meier curve labelled with incorrect absolute risk reduction information, and
• secondary outcome data without providing the context of the study, including its failure to achieve the primary endpoint.

The Panel ruled a breach of the following Clauses of the 2021 Code:

Breach of Clause 5.1

Failing to maintain high standards

Breach of Clause 6.1 (x3)

Making a misleading claim

In relation to allegations about off-label promotion of macitentan and the location of the prescribing information, the Panel ruled no breach of the following Clauses of the 2021 Code:

No Breach of Clause 11.2 (x3)

Requirement that a medicine must be promoted in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics

No Breach of Clause 12.1

Requirement to include prescribing information

No Breach of Clause 12.6

Requirement to include a prominent statement as to where the prescribing information can be found on promotional material on the internet

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