AUTH/3168/2/19 - Complainant v Janssen

Company website

  • Received
    27 February 2019
  • Case number
  • Applicable Code year
  • Completed
    27 June 2019
  • No breach Clause(s)
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    Published in the May 2020 Review

Case Summary

A contactable individual who described him/herself as a concerned UK health professional, complained about the Janssen Medical Cloud website.  The website was described on its homepage as being for healthcare professionals providing information about Janssen, product information, medical education and resources for patient management by disease area.  Links were included to prescribing information and the home page included that the website contained promotional content.

The complainant stated that Janssen Medical Cloud appeared to be a website that was promotional and had areas that probably should not be. 

The complainant stated that he/she was initially concerned about the way medical was so overtly used on a promotional website but then he/she realised that this was merely the tip of the iceberg.  The complainant highlighted a number of concerns.

The detailed response from Janssen is given below.

With regard to various allegations that changes to summaries of product characteristics (SPC) had not been reflected in prescribing information, the Panel ruled no breach of the Code.  This applied to material about Edurant, Symtuza, Stelara and Zytiga.  The Panel also ruled no breach in relation to Trevicta,

Xeplion and Risperdal oral tablets and solution and Risperdal Consta in the Schizophrenia portfolio.

Breaches of the Code were ruled in relation to similar allegations about Trevicta, Xeplion and Risperdal Consta prescribing information within a presentation on Schizophrenia  including that high standards had not been maintained.

The Panel ruled a breach of the Code as high standards had not been maintained in relation to an alleged failure to include all the special warnings and precautions for using Edurant. Warnings relating to pregnancy were not included in a table.

The failure to update references to when pages were last updated was not considered to be a matter covered by the requirements for prescribing information and no breach was ruled in relation to two similar allegations in this regard.

The Panel ruled no breach in that the use of a supressed zero in a graph did not exaggerate the differences between the products as alleged.  A second graph which also used a suppressed zero was ruled in breach as in this instance the presentation exaggerated the differences between the products.

The Panel ruled a breach as it considered a reference to ‘the safe and effective use of Janssen medicines’ in a ‘meet the team’ section might be seen as a claim that such medicines were safe. The Panel ruled breaches of the Code as a Tremfya video did not have the up-to-date prescribing information.  A further breach was ruled due to the lack of clear prominent statement as to where the prescribing information could be found. 

No breach was ruled with regard to certification of presentations published in the oncology section on the website.

The Panel ruled that the facility for a health professional to forward materials to colleagues did not amount to disguised promotion.  It would be clear to recipients that Janssen had created the email template and that the content was from the company.  Prescribing information was available on the website accessed by the link and the email creation was certified as part of the website.  No breaches of the Code were ruled.

The Panel did not consider that the website was disguised promotion.  It was clearly promotional.  The Panel ruled no breach in this regard. 

The Panel did not consider that the complainant had shown on the balance of probabilities that the training of Janssen staff failed to meet the requirements of the Code and ruled no breach of the Code.

The Panel considered it was very important that prescribing information was up-to-date.  It noted that there were some errors on the website and also noted its rulings above.  The Panel considered therefore that high standards had not been maintained and ruled a breach. 

The Panel noted the complainant stated that if the majority of the allegations were found to be true, then he/she was alleging a breach of Clause 2.  The majority of allegations had not been ruled in breach.  The Panel noted the errors with out of date prescribing information and its ruling that high standards had not been maintained.  It also noted Janssens’s submission that the up to date prescribing information was available on the home page.  Clause 2 of the Code was a sign of particular censure and reserved for such use.  The Panel considered that based on the allegations, on balance, the circumstances did not warrant a ruling of a breach of Clause 2 of the Code.