Janssen Blames "Human Error" for Breach of ABPI Code re Off-Label Promotion of STELARA for Crohn's Disease | Pharma Industry Regulation | Scoop.it

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.