AUTH/3712/11/22 - Complainant v Abbvie

Promotion of Rinvoq

  • Received
    22 November 2022
  • Case number
  • Applicable Code year
  • Completed
    18 August 2023
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal

Case Summary

This case concerned allegations about the suitability of imagery used on two Rinvoq (upadacitinib) webpages related to rheumatoid arthritis and psoriatic arthritis. 

The Panel ruled a breach of the following clauses of the 2021 Code on the basis that it considered: 

  • the use of an image of a young female surfing on the webpage related to psoriatic arthritis might misleadingly imply that patients taking Rinvoq would be able to perform such strenuous exercise which in the Panel’s view was unlikely and which was compounded by the claim of ‘rapid and sustained joint efficacy’ and created a misleading impression in that it did not reflect the typical patient with moderate to severe psoriatic arthritis and could not be substantiated
  • the image of a woman of childbearing potential on each webpage without including a reference to the fact it was contraindicated in pregnancy or the warning that women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of Rinvoq was misleading
  • the use of imagery of a young female, in association with a product with a known risk of foetal harm, without highlighting that there were restrictions on use in this population had the potential to impact patient safety and was such that AbbVie had brought discredit upon, and reduced confidence in, the industry. 

Breach of Clause 2

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

Breach of Clause 5.1

Failing to maintain high standards

Breach of Clause 6.1

Failing to ensure material was sufficiently complete and not misleading

Breach of Clause 6.2

Making an unsubstantiated claim

Breach of Clause 6.3

Failing to ensure artwork conformed to the letter and spirit of the Code

 The Panel ruled no breach of the following Clauses of the 2021 Code on the basis that:

  • Rinvoq was licensed for rheumatoid arthritis and psoriatic arthritis in adult patients only. Therefore, the Panel did not consider that failure to include the warning, that female paediatric patients taking Rinvoq and/or their parents/caregivers should be informed about the need to contact the treating physician once the patient experiences menarche (starting menstruation), on the webpages at issue was, in the particular circumstances of the case, misleading or incapable of substantiation
  • The complainant had not established that an image of a young female sitting on a swing swinging on the rheumatoid arthritis webpage was not representative of a typical patient with moderate to severe rheumatoid arthritis; while some fitness was required to generate the swinging movement, the activity did not appear to require particular stability or strength in the joints.

No Breach of Clause 6.1

Requirement that material must be sufficiently complete and not be misleading 

No Breach of Clause 6.2

Requirement that claims and information must be capable of substantiation

No Breach of Clause 6.3

Requirement that all artwork must conform to the letter and spirt of the Code

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