AUTH/2870/8/16 - Voluntary admission by Janssen

Trevicta advertisements

  • Received
    10 August 2016
  • Case number
    AUTH/2870/8/16
  • Applicable Code year
    2016
  • Completed
    23 August 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 in relation to a number of Trevicta (paliperidone palmitate 3 monthly) journal advertisements placed during July and August 2016. Trevicta, a 3-monthly injection, was indicated for the maintenance treatment of schizophrenia in adults who were clinically stable on 1-monthly paliperidone palmitate injectable product.

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.

Janssen explained that the advertisements were two page advertisements in which the prescribing information appeared overleaf, however the reference to where it could be found was missing, which was a breach of the Code. This was not picked up in the certification process.

Janssen submitted that the job bags had erroneously been uploaded into Zinc as digital job bags whereas the advertisements were in fact both digital and hard copy. This error meant that the journal advertisements were only electronically certified and not also certified in their final hardcopy form and so Janssen did not pick up on the missing prescribing information location reference. Janssen considered that the failure to certify the final form of the hardcopy advertisements also amounted to a breach of the Code.

The details submitted by Janssen are given below.

The Panel noted that the two page advertisements in question had prescribing information overleaf on the second page but the reference to where to find it was missing from the first page. A breach of the Code was ruled as acknowledged by Janssen.

The Panel noted Janssen's admission that the journal advertisements were only electronically certified and not also certified in their final hardcopy form. The Panel thus ruled a breach of the Code as acknowledged by Janssen.