AUTH/2871/8/16 - Voluntary admission by Janssen

Pre-licence promotion

  • Received
    22 August 2016
  • Case number
    AUTH/2871/8/16
  • Applicable Code year
    2016
  • Completed
    06 October 2016
  • Breach Clause(s)
  • Sanctions applied
    Undertaking received
  • Additional sanctions
  • Appeal
    No appeal
  • Review
    November 2016 Review

Case Summary

​Janssen-Cilag voluntarily admitted breaches of the Code as a Crohn's disease awareness campaign initiated and approved by the Janssen European team was used in the UK and amounted to prelicence promotion.

The campaign consisted of an email sent on 2 June and images and news headline links made available to Gastroenterology members 29 June – 29 July.

The email was headed 'Developed under the direction and sponsorship of Janssen Pharmaceutical Companies' followed by 'Crohn's. Let's re-write their story'. The next heading was 'Relapse' where 'lapse' had been crossed out and 'mission' added ie 'Relapse' had been amended to 'Remission' followed by 'A disease with many unknowns, has many treatment challenges'. The email stated that there was no known cause or cure for Crohn's disease but with better understanding of the pathophysiology the ambition of treatment was to move from short-term symptom control to more targeted long term disease modification. There were high treatment failure rates with existing biological therapies (40% of patients did not respond to anti-tumour necrosis factor (TNF)). Patients needed more effective treatment options to improve overall disease management and optimise outcomes. The email then referred to the need to understand the disease pathway at the molecular level followed by 'Janssen has been working tirelessly to improve the way Crohn's is managed' and that the company was 'committed to discovering pioneering treatments for Crohn's disease'. Janssen introduced the first anti TNF in 1998 and continued to lead the way. It had expanded its research focus to include other targets now known to drive inflammation and autoimmune processes. Working with others Janssen was committed to developing new tailored therapeutic options 'in order to provide the right treatment for the right person in every part of the world'.

The email concluded with a box headed 'Learn more about Janssen's commitment to Crohn's management' with three links to the results of studies of ustekinumab in Crohn's Disease.

The last sentence below the references was 'This promotional communication is provided by [named third party]'.

The images and news headline links were made available to Gastroenterology members accessing the Medscape website; the alerts appeared adjacent to other news headlines at that time. During that period, the headline 'Remission: the goal for all patients with Crohn's disease ' followed by 'information from industry' were shown in three forms, desktop, news section and home page versions, to UK gastroenterologists. A link from the news headline took readers to the same email content 'Remission: Mapping new pathways for Crohn's disease treatment'.

Stelara (ustekinumab) was currently indicated for the treatment of moderate to severe plaque psoriasis and for the treatment of adult patients with psoriatic arthritis. Stelara did not yet have a licensed indication for the treatment of Crohn's disease. In November 2015 Janssen sought approval from the European Medicines Agency for this indication.

 As Paragraph 5.6 of the Constitution and Procedure required the Director to treat a voluntary admission as a complaint, the matter was taken up with Janssen.

The detailed response from Janssen is given below.

The Panel noted that Janssen in Europe had emailed UK health professionals without the involvement of Janssen UK which had therefore not certified the materials. The email could also be accessed from advertisements which read 'Remission: the goal for all patients with Crohn's disease. Information from industry'. These advertisements were accessible to members of Medscape who were gastroenterologists.

The Panel noted that there appeared to be a serious error in that the relevant Janssen EMEA standard operating procedure (SOP) required materials to be sent to the local company for approval prior to use and this had not happened. Janssen UK submitted that this was due to human error. This appeared to the Panel to be conduct that fell short of competent care.

The Panel considered that the email was clearly promotional. It discussed the treatment of disease pathways of Crohn's disease and provided links to results of studies using Stelara for Crohn's Disease. It mentioned that Janssen was committed to discovering pioneering treatments for Crohn's disease and the need for more effective treatment options. Stelara was not indicated for Crohn's Disease. The advertisements were linked to the email and thus were also promotional. The Panel ruled a breach of the Code as the material was inconsistent with the Stelara summary of product characteristics (SPC) as acknowledged by Janssen UK. The material had not been certified and a breach of the Code was ruled as acknowledged by Janssen.

The Panel ruled that high standards had not been maintained in breach of the Code as acknowledged by Janssen UK. It considered that by promoting an unlicensed indication and failing to certify the material it brought discredit upon and reduced confidence in the pharmaceutical industry. The Panel ruled a breach of Clause 2.