AUTH/3633/4/22 - Complainant v Novartis

Allegations misleading information for Entresto on a Novartis promotional website

  • Received
    13 April 2022
  • Case number
  • Completed
    27 April 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 allegations that the 'Starting and Monitoring Entresto' page of the Entresto (sacubitril/valsartan) promotional website contained misleading information and omitted important safety information.

The Panel ruled a breach of the following Clauses of the 2021 Code as it considered that
by providing some, but not all, the relevant information in relation to hepatic impairment and renal impairment in a section of the webpage which was intended to advise health professionals on considerations when using the medicine, was misleading:

Breach of Clause 6.1

Providing misleading information

Breach of Clause 5.1

Failing 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 on the basis that the complainant had not demonstrated that:
• health professionals would be misled by the claim ‘Monitoring and using Entresto is simple’ or that the claim, in the context of the particular webpage at issue, could not be substantiated;
• based on the very narrow allegation, the omission of liver function monitoring in the monitoring section of the webpage was misleading, noting the Entresto SPC did not specifically state that liver function should be monitored:

No Breach of Clause 6.1

Requirement that claims and information must not be misleading

No Breach of Clause 6.2

Requirement that claims must be capable of substantiation

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